Careers at ChromaCode

We are seeking a senior software engineer with experience developing back end systems to join our growing software team. You will work with the software development team to build out a web-based data analysis platform and associated applications. The position entails the development of web services using a variety of technologies. We are hiring for multiple positions and the seniority/title of the final position will reflect your experience.

Who we are

We are a fast-growing early stage company, passionate about increasing the information content of molecular diagnostics data to drive better decision-making. We use state of the art methods to analyze and improve information content from widely used life science instruments. You will join a team of software developers and scientists in a well-funded, exciting startup environment. We are developing analytical, statistical, and visualization algorithms and implementing tools and software pipelines used to analyze large multidimensional biological datasets, e.g. DNA/RNA data.

What you will be responsible for

• Implementing cloud-based services focusing on scalability and reliability
• Implementing APIs for custom web application and B2B integrations
• Building reusable code and libraries
• Ensuring implementation of security best practices in services and data management
• Package, deploy, and maintain production systems

Your ideal qualifications

You are a collaborative, strong communicator who effectively adjusts to technical and non-technical audiences. You are able to prioritize and deliver results with a high emphasis on quality, technical rigor, and attention to detail. You love working in a fast-paced environment that rewards innovation and creativity.

• 5+ years of professional software development experience
• Strong knowledge of some common languages (Python, Go, Java, C/C++)
• Strong knowledge of (semi-)structured data services (RDBMS, KVS, Doc stores, Index services)
• Strong principles in software design, object-oriented, procedural and event-driven
• Familiarity with Scrum or Kanban to enable effective organization and distributed work
• Strong knowledge of SCM systems (Git) and effective code review techniques

Additional experience (nice to have):

• Experience with authorization frameworks (OAuth2, OIDC)
• Experience with serverless architectures (Lambda, Knative)
• Experience developing public facing APIs and standards (OpenAPI)
• Experience with log aggregation and indexing tools (Splunk, SumoLogic)
• Experience with service observability and monitoring tools (Jaeger, NewRelic)
• Knowledge of application containerization technologies (Docker)
• Experience developing in and contributing to a DevOps culture
• Familiarity with clinical diagnostics environment and understanding of Design Control practices as they relate to software development
• Knowledge of security and privacy regulatory frameworks such as ISO27001 and HIPAA

This position is based in Carlsbad, California. ChromaCode is an equal opportunities employer.

If interested, please email resume and cover letter describing your qualifications to:

hr@chromacode.com

ChromaCode is looking for an experienced Research Associate to join our Assay Development team.  To be successful, you’ll need a strong background in molecular diagnostics and a track record of successfully contributing to the development of nucleic-acid-based assays, specifically working in a BSL-2 environment.  Experience working with real-time PCR technology is a requirement.

The person filling this role will be part of a dynamic assay team developing ChromaCode HDPCR assays for real time and digital PCR applications.  Attention to detail, tenacity, and flexibility is extremely helpful in this role. Working closely with team members will be essential to success.

Who we are

We are a company interested in substantially increasing information in multiplexed molecular diagnostics. We leverage novel methods to analyze and enhance information from popular life science instrumentation.

What you will be responsible for

• Extraction of nucleic acids in a Biosafety Level 2 laboratory
• Maintaining usage logs of clinical specimens and sample stocks
• Execution of laboratory work under the direction of your supervisor
• Documentation of work in accordance with ChromaCode procedures

Your ideal qualifications

• You are highly organized and eager learner with the desire to advance projects and support your team in a fast-paced work environment
• BS in molecular biology or related discipline with 2+ years of industry or academic R&D experience or 2+ years clinical laboratory setting
• Demonstrated experience in:
  • operation of common instrumentation/methodologies for nucleic acid extraction
  • setting up and running PCR/qPCR assays on commonly used real-time PCR instruments
  • maintaining records
  • successful execution in a team setting
• Experience in product development under Design Control is a plus

We are looking for an experienced field market development scientist who will support the go-to-market strategy for all ChromaCode products. We want you to drive product adoption, investigate new opportunities as a partner to sales and marketing and assist as a back-up person in the lab when workload is at capacity. You will be a key member of a cross-functional team ensuring successful product adoption, transfer of scientific knowledge and identification of new opportunities to drive commercial success.

Who we are:

We are a company interested in substantially increasing information in multiplexed molecular diagnostics. We leverage novel methods to analyze and enhance information from popular life science instrumentation.

What you will be responsible for:

• This is a full-time position that is based in the USA with travel time is expected to be a minimum of 60-70%
• Demonstrating the ChromaCode technology (assay and software) on-site at customer labs
  • Demonstrate product assay workflow and optimize customer workflow
  • Be the resident expert in the field to answer technical questions
  • Present technology to lab personnel and key decision makers
  • Troubleshoot issues on-site
• Develop application notes and white papers to support strategic market development
• Provide technical support to customers via email, telephone, or in person site visits
• Pre-sales support by identify new opportunities in the field for the company technology as part of market development
• Assist Account Executives in driving sales through technical knowledge and with the RFPs’ technical details as needed
• Communicate voice of customer (VOC) to the R&D team for product enhancements and new product development by assessing product requirements through customer interaction
• Assisting in lab in-house as needed on assay development or verification and validation projects

Your ideal qualifications:

• Bachelor’s or Master’s in molecular biology, microbiology, genetics, or related field with a minimum of 5 years lab bench experience and minimum of 3 years customer facing experience
• Experience and knowledge of dPCR and ddPCR technologies a must
• Experience with assay and/or software development life cycle management.
• Experience writing scientific posters, publications and preparing oral presentations
• Demonstrated ability to present to all levels of an organization including the C-Suite
• Experience in regulated (FDA) and non-regulated (life science research) and laboratory-developed test (LDT) environments
• The ability to dialog with customers and internal assay developers at a deep technical level
• Basic fundamental marketing skills (market analysis, branding, social media, trade show management, advertising, etc.)
• Ability to seek out new opportunities in the field and bring forth to sales and marketing teams to work towards a close

If interested, please email resume and cover letter describing your qualifications to: hr@chromacode.com

We are looking for a dedicated Research Associate with expertise in developing novel molecular phenotyping technologies to join a talented team in our advanced technology group. The ideal candidate will contribute to the development of new, high multiplex analyte detection technologies, consistently generate high quality, reproducible data, and be comfortable in a dynamic and fast-paced environment. They will work with scientists, development, software, operations, and business teams to drive the success and impact of novel technologies. The candidate will have incredible enthusiasm for the life sciences, is an organized and effective communicator, and is excited for ChromaCode’s mission.

Who we are:

ChromaCode is a fast-growing life sciences tools company, passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We are currently using our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19.  You will join a team of highly talented scientists and researchers working on really challenging problems in a well-funded, exciting environment.

What you will be responsible to:

• Work both jointly with colleagues and independently to develop, design, and perform experiments to assess new molecular methods for high multiplex analyte detection
• Interpret data and, leveraging your domain knowledge, draw conclusions from experiments to impact project decisions and directions
• Recommend next experimental steps based on results, influencing key project and team directions, and technical approaches to evaluate and implement
• Accurately document and communicate experimental procedures, observations, and insights
• Summarize key data and findings and communicate them to peers through visualizations, reports, and/or presentations

Your ideal qualifications:

• BSc in Biochemistry, Bioengineering, Genetics, Genomics, Molecular Biology, Cell Biology, or related field, or equivalent experience
• 2-5 years of post-undergraduate experience in an experimental lab setting
• Prior experience working with clinical biospecimens (blood, tissue, FFPE, plasma)
• Prior experience with nucleic acid purification and quality control
• Sound understanding of PCR, including PCR assay design and data analysis
• Solid communication skills and ability to interface with other researchers
• Prior expertise developing qPCR and/or digital PCR assays a plus

If interested, please email resume and cover letter describing your qualifications to: hr@chromacode.com

ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at hr@chromacode.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

We are looking for a creative, independent Staff Scientist with technical expertise in developing novel molecular phenotyping technologies to join a talented team in our advanced technology group. The ideal candidate will lead development of new, highly multiplex analyte detection technologies, motivate new market applications and strategic directions, and be comfortable in a dynamic and fast-paced environment. They will work cross-functionally with development, software, operations, and business teams to drive the success and impact of novel technologies. The candidate will have incredible enthusiasm for the life sciences, is an organized and effective communicator, and is excited for ChromaCode’s mission.

Who we are:

ChromaCode is a fast-growing life sciences tools company, passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We are currently using our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19.  You will join a team of highly talented scientists and researchers working on really challenging problems in a well-funded, exciting environment.

What you will be responsible for:

• Ideation, design, development, execution, and analysis of new molecular methods for high multiplex analyte detection, research projects, and externally partnered studies
• Generate strategies and key experimental results that influence team directions and broader company strategy
• Communicate experimental work and insights internally and externally
• Design and lead the cross-disciplinary transition of new assays and iterations in collaboration with diverse technical peers
• Evaluate and integrate emerging technologies into product roadmaps
• Initiate and lead strategic academic and/or industrial collaborations

Your ideal qualifications:

• PhD in Biochemistry, Bioengineering, Genetics, Genomics, Molecular Biology, Cell Biology, or related field, or equivalent experience
• 5+ years of post-graduate experience creating and developing novel technologies for molecular/cellular phenotyping or diagnostics
• Demonstrated record of research and development for novel molecular technologies, as evidenced through related peer reviewed publications, patents, or product launches
• Strong communication skills and ability to interface with cross-functional, interdisciplinary teams
• Experience with the end-to-end process of creating, developing, and commercially deploying complex molecular assays
• Domain expertise in molecular photochemistry, nucleic acid logic devices, and/or highly multiplexed molecular detection systems
• Knowledge and expertise with massively parallel sequencing and analysis workflows
• Experience with external engagement(s) with potential partners
• Familiarity collaborating with development, business, operations, and regulatory functions.

If interested, please email resume and cover letter describing your qualifications to: hr@chromacode.com

ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at hr@chromacode.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

Looking for a proactive, results-driven Product Manager to join a highly collaborative and fast-moving team dedicated to developing next generation PCR based product portfolio. As the Product Manager for Infectious Diseases, you will be responsible for driving marketing initiatives, product life cycle management, and leading VoC activities to guide new product development.  In this role, you will interface with multiple functions to contribute to building the product roadmap and execute on global product commercialization programs.

Who we are:

We are a fast-growing life sciences tools company, passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We are currently using our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19.  You will join a team of highly talented people in a well-funded, exciting environment.

What you will be responsible for:

• Leading the strategy for new product development within molecular diagnostics Infectious Diseases domain based on understanding of market opportunity, customer needs, competitive landscape, and business potential
• Guiding new product development by gathering voice of customer research, defining critical customer and product requirements, prioritizing features needed, and building associated business plan
• Analyzing market trends, customer requirements, and competitive strategy, and identify opportunities for increasing customer and business value through product differentiation
• Creating and executing launch plans including market segmentation, value proposition, commercialization strategy, pricing, regulatory strategy, reimbursement approach, competitive analysis, and forecasting
• Serving as the customer advocate for communicating VOC internally and aaccross cross functional teams through project and core teams
• Partnering with key functions to address including R&D, Manufacturing, Finance, Customer Services, Quality, Regulatory and others as needed
• Developing and delivering product training programs for internal and external customers (Technical Support, Field Application Specialists, and Sales)
• Designing and executing marketing campaigns to achieve strategic and commercial objectives of the product line
• Collaborating with MarCom to create product marketing collateral and content such as sales documentation, product videos, website copy, blog posts, brochures, on-line guides, and other forums
• Assessing and evaluating market and competition to help develop and deploy key messages and communication strategies for the product line
• Managing total Product Life Cycle and use data to drive decision making to the scope and prioritize new requirements or address defects/issues in the product based on business and customer impact
• Assisting with the management of sales forecast with operations/planning to ensure proper inventory management of product line
• Assisting with long-term strategy development and product pipeline portfolio management aligned with business strategy

Your ideal qualifications:

• Minimum 3-5+ years of experience in product or marketing management of molecular diagnostics in Infectious Diseases domain.
• Understanding of the applications of molecular diagnostics in Infectious Diseases testing for different applications
• Knowledge of Infectious Diseases landscape and testing market
• Bachelor’s degree in biological sciences (genetics, molecular biology, microbiology, immunology, or biochemistry……..etc.)
• Experience in new product development and lifecycle management
• Demonstrated effective verbal and written communication skills+
• Ability to work independently in a fast-paced changing environment with deadline and resource constraints+
• Experience working in a regulated environment and knowledge of IVD and LDT products
• Ability to travel up to 25% of the time

If interested, please email resume and cover letter describing your qualifications to: hr@chromacode.com

ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at hr@chromacode.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

Looking for a proactive, results-driven individual to join a highly collaborative and fast-moving team dedicated to developing next generation PCR based product portfolio. As Molecular Diagnostics Strategic Marketing Director, you will be responsible for driving product development strategy, market research activities, marketing initiatives, product life cycle, and product commercialization strategy.  In this role you will manage a team of Product Managers and guide the establishment of functional excellence.  The role will interface with multiple functions to contribute to building the product roadmap and execute on global product commercialization programs.

The Strategic Marketing Director will lead the development and execution of global product strategy and integrated marketing plans needed for the commercialization of a portfolio of products.  The role will lead a portfolio of products through dedicated product managers by application for specific disease state.

Who we are:

We are a fast-growing life sciences tools company, passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We are currently using our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19.  You will join a team of highly talented people in a well-funded, exciting environment.

What you will be responsible for:

• Developing the strategic product roadmap across product categories guiding new and existing activites required to address market needs, business opportunities, lifecycle requirements, and corporate objectives
• Leading a team of Product Managers to integrate and prioritize activities required for existing and new product development
• Executing with cross-functional team the development roadmap defined by the portfolio strategy
• Engaging with cross-functional core-teams to provide input into key objectives, priorities, and planning of key activities
• Building and interacting with KOLs to help guide product, marketing strategies, and scientific evidence
• Developing and executing marketing plan that covers: strategic product development and go-to-market/tactical plans for current and future products in the portfolio
• Develop and rationalize business proposals for new product development, existing product expansion, or other activities
• Following product development processes and ensuring consistency across product categories
• Growing marketing competency by establishing best practices and functional excellence activities
• Managing total Product Life Cycle and use data to drive decision making to the scope and prioritize new requirements or address defects/issues in the product based on business and customer impact
• Coordinating market research activities to guide the product portfolio strategy and prioritization
• Collaborating with MarCom to ensure alignment of brand elements with business core values, customer needs, value proposition, and corporate objective.
• Coordinating with MarCom to create product marketing collateral and content such as sales documentation, product videos, website copy, blog posts, brochures, on-line guides, and other forums.
• Driving culture of collaboration withing the marketing teams and across the organization.
• Designign and executing marketing campaigns to achieve strategic and commercial objectives of the product line.
• Assisting with the management of sales forecast with operations/planning to ensure proper inventory management of product line.

Your ideal qualifications:

• Minimum 10+ years of experience in product or marketing management of molecular diagnostics product range
• Experience working within the molecular in vitro diagnostics (IVD) market with strong knowledge of current marketed products and competition
• Required experience in upstream marketing and product management
• Domain knowledge of Molecular Diagnostics with experience in engaging at different stages of product development
• Bachelor’s degree in biological sciences (genetics, molecular biology, immunology, or biochemistry……..etc.).
• Skills in aspects of business research (industry analysis, competitive benchmarking, VOC, and market studies qualitative/quantitative)
• Experience in marketing strategy development and execution for a portfolio of products
• Experience in new product development and lifecycle management
• Demonstrated effective verbal and written communication skills+
• Ability to work independently in a fast-paced changing environment with deadline and resource constraints+
• Experience working in a regulated environment and knowledge of IVD and LDT products
• Ability to travel up to 25% of the time

If interested, please email resume and cover letter describing your qualifications to: hr@chromacode.com

ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at hr@chromacode.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

Looking for a proactive, results-driven Product Manager to join a highly collaborative and fast-moving team dedicated to developing next generation PCR based product portfolio. As the Product Manager for NIPT, you will be responsible for driving marketing initiatives, product life cycle management, and leading VoC activities to guide new product development.  In this role, you will interface with multiple functions to contribute to building the product roadmap and execute on global product commercialization programs.

Who we are:

We are a fast-growing life sciences tools company, passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We are currently using our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19.  You will join a team of highly talented people in a well-funded, exciting environment.

What you will be responsible for:

• Leading the strategy for new product development within noninvasive prenatal testing (NIPT) domain based on understanding of market opportunity, customer needs, competitive landscape, and business potential
• Guiding new product development by gathering voice of customer research, defining critical customer and product requirements, prioritizing features needed, and building associated business plan
• Analyzing market trends, customer requirements, and competitive strategy, and identify opportunities for increasing customer and business value through product differentiation
• Creating and executing launch plans including market segmentation, value proposition, commercialization strategy, pricing, regulatory strategy, reimbursement approach, competitive analysis, and forecasting
• Serving as the customer advocate for communicating VOC internally and aaccross cross functional teams through project and core teams
• Partnering with key functions to address including R&D, Manufacturing, Finance, Customer Services, Quality, Regulatory and others as needed
• Developing and delivering product training programs for internal and external customers (Technical Support, Field Application Specialists, and Sales)
• Designing and executing marketing campaigns to achieve strategic and commercial objectives of the product line
• Collaborating with MarCom to create product marketing collateral and content such as sales documentation, product videos, website copy, blog posts, brochures, on-line guides, and other forums
• Assessing and evaluating market and competition to help develop and deploy key messages and communication strategies for the product line
• Managing total Product Life Cycle and use data to drive decision making to the scope and prioritize new requirements or address defects/issues in the product based on business and customer impact
• Assisting with the management of sales forecast with operations/planning to ensure proper inventory management of product line
• Assisting with long-term strategy development and product pipeline portfolio management aligned with business strategy

Your ideal qualifications:

• Minimum 3-5+ years of experience in product or marketing management of NIPT
• Knowledge of reproductive health landscape and testing market
• Bachelor’s degree in biological sciences (genetics, molecular biology, immunology, or biochemistry……..etc.)
• Knowledge of molecular diagnostics testing domain
• Experience in new product development and lifecycle management
• Demonstrated effective verbal and written communication skills+
• Ability to work independently in a fast-paced changing environment with deadline and resource constraints+
• Experience working in a regulated environment and knowledge of IVD and LDT products
• Ability to travel up to 25% of the time

If interested, please email resume and cover letter describing your qualifications to: hr@chromacode.com

ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at hr@chromacode.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

ChromaCode is looking for an experienced Scientist to support some of our most critical assay development efforts.  We want you to build multiplexed assays for real-time and digital PCR instruments.  To be successful, you’ll need a strong background in molecular diagnostics and a track record of successfully developing nucleic-acid-based assays.  Experience working with real-time and digital PCR technology is a major plus.

The person filling this role will have proven experience in designing, executing and reporting experiments.  You will work cross-functionally across Assay Development, Data Science, and Manufacturing to develop new products.

Who we are

We are a well-funded, multiplexed molecular diagnostics start-up with a bioinformatics focus and pedigree from Illumina, Google[x], Luminex, and Caltech. We leverage patented mathematical methods and algorithmic enhancements to enrich signal processing from the most popular life science instrumentation.  We are using this to extract new information on biochemistry reactions and substantially increase the performance capabilities of today’s gold-standard biochemical assays at a very low cost.

What you will be responsible for

• Design and Execute experiments and provide solutions for ChromaCode Assays and Technology.
• Guide Junior Scientists in experiment design and analysis.
• Use statistical methods to analyze data and generate useful reports
• Design studies that incorporate requirements from regulatory agencies
• Participate in scientific troubleshooting efforts to speed product development

Your ideal qualifications

• A BS, MS, or PhD in the Life Sciences (Biology, Molecular Biology, Biochemistry) or another relevant field.
• PhD with 1-3 years professional experience, MS with 3-5 years professional experience, BS with 5+ years professional experience. Experience ideally in biotech or related industries.
• Strong problem-solving skills and demonstrated knowledge of PCR based applications.
• Background in human genetics/genomics
• Experience in Design of Experiments (DoE).
• Experience working with aggregate data sets to identify trends and areas for improvement.
• Experience using statistical computer languages (R, Python, SQL, etc.) to manipulate data and draw insights from large data sets is a plus.
• Experience with biochemistry-related data and troubleshooting.
• Excellent communication and presentation skills.
• Experience with IVD, CE product development a plus.
• Experience working in a startup environment a plus.
• This position will be based in Carlsbad, California.

If interested, please email resume and cover letter describing your qualifications to:

hr@chromacode.com

Looking for a proactive, results-driven individual to join a highly collaborative and fast-moving team dedicated to developing next generation PCR based product portfolio. As the Business Development Director you will be responsible for identifying, assessing, and conducting diligence on new business development opportunities for partnerships, alliances, and collaborations that are in line with the overall busines and strategic growth objectives.  The successful candidate will be responsible for developing the business development & licensing strategy for multiple strategic IVD applications using the ChromaCode technology.  This person will report directly into the VP, Marketing and Business Development

Who we are:

We are a fast-growing life sciences tools company, passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We are currently using our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19.  You will join a team of highly talented people in a well-funded, exciting environment.

What you will be responsible for:

• Develop and execute business development and licensing strategies to leverage ChromaCode technology
• Assess growth opportunities, lead cross-functional search, evaluation and diligence teams and negotiate transactions
• Consider broad corporate priorities and participate in strategy planning for  decisions required for corporate growth
• Participate in and lead negotiations in business transactions
• Work effectively with legal, finance, commercial, clinical and scientific, and corporate development teams and make business development proposals to senior management
• Lead evaluations of all aspects of across the relevant assessment areas: proposed clinical benefit, mechanism, preclinical data, manufacturing, regulatory strategy, clinical development path, intellectual property and commercial potential
• Work remotely is an option, out of a home office, up to 50% travel required
• All other duties as assigned or necessary
• Proven track record constructing, managing, and executing business development deals

Your ideal qualifications:

• 10+ years in biotechnology, IVD, and molecular diagnostics
• Track record of leading strategic collaboration and in-licensing agreements including running due diligence processes and leading complex negotiations exemplified by a very strong deal sheet
• Ability to identify and prioritize risks across functional areas, weigh those appropriately with benefits of investment, and effectively frame business decisions for senior management
• Strong communication and leadership skills necessary to effectively lead diligence teams and navigate Company’s corporate structure, i.e., possessing organizational savvy
• Thorough understanding of FDA regulations within the U.S. in addition to global laws and regulations related to IP and legal
• Bachelor’s Degree in Life Sciences required, graduate degree preferred

If interested, please email resume and cover letter describing your qualifications to: hr@chromacode.com

ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at hr@chromacode.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

We are seeking a software developer with experience in devops platform engineering to join our growing team. You will work with software engineers to build out a cloud-based data analysis platform and associated web applications. You will be responsible for building tools to support software development and releases. You will co-ordinate with the software development team to ensure on-time delivery of production releases. We are hiring for multiple positions and the seniority/title of the final position will reflect your experience.

Who we are

We are a fast-growing early stage company, passionate about increasing the information content of molecular diagnostics data to drive better decision-making. We use state of the art methods to analyze and improve information content from widely used life science instruments. You will join a team of software developers and scientists in a well-funded, exciting startup environment. We are developing analytical, statistical, and visualization algorithms and implementing tools and software pipelines used to analyze large multidimensional biological datasets, e.g. DNA/RNA data.

What you will be responsible for

• Building and maintaining CI/CD systems
• Developing provisioning and deployment automation systems
• Coordinating and managing software releases
• Providing tools and support to other software engineers

Your ideal qualifications

You are a collaborative, strong communicator who effectively adjusts to technical and non-technical audiences. You are able to prioritize and deliver results with a high emphasis on quality, technical rigor, and attention to detail. You love working in a fast-paced environment that rewards innovation and creativity.

• 5 years development and/or operations roles, preferably a combination
• Experience managing a high-availability production environment
• Demonstrated knowledge of Kubernetes
• Demonstrated knowledge of Git
• Experience with Jenkins Pipeline development
• Working knowledge of networking concepts (routing, vlans, vpn)
• Strong proficiency with Linux and Bash scripting
• Knowledge of security best practices and experience implementing them
• Experience with AWS, primarily IAM and networking

Additional qualifications:

• Experience with other languages such as Python, Go, or C#
• Knowledge of containerization technologies (e.g. Docker)
• Knowledge of security and privacy regulatory frameworks such as ISO27001 and HIPAA

This position is based in Carlsbad, California. ChromaCode is an equal opportunities employer.

If interested, please email resume and cover letter describing your qualifications to:

hr@chromacode.com

We are seeking a software developer with experience in web application development to join our growing software team. You will work with the software development team to build out a web-based data analysis platform and associated applications. The position entails the development of user-friendly interactive web frontends using JavaScript, HTML, and CSS. You will develop web services using a variety of technologies. We are hiring for multiple positions and the seniority/title of the final position will reflect your experience.

Who we are

We are a fast-growing early stage company, passionate about increasing the information content of molecular diagnostics data to drive better decision-making. We use state of the art methods to analyze and improve information content from widely used life science instruments. You will join a team of software developers and scientists in a well-funded, exciting startup environment. We are developing analytical, statistical, and visualization algorithms and implementing tools and software pipelines used to analyze large multidimensional biological datasets, e.g. DNA/RNA data.

What you will be responsible for

• Building reusable code and libraries
• Optimizing web applications for speed and scalability
• Translating UI/UX wireframes to visual elements
• Integrating front-end and back-end aspects of web applications

Your ideal qualifications

You are a collaborative, strong communicator who effectively adjusts to technical and non-technical audiences. You are able to prioritize and deliver results with a high emphasis on quality, technical rigor, and attention to detail. You love working in a fast-paced environment that rewards innovation and creativity.

• At least 2 years of professional software development experience
• Experience with client-side scripting and JavaScript frameworks (e.g. React, Redux, Node.js)
• Solid grasp of the principles of creating secure web applications
• Experience developing under version control using tools such as Git

Additional qualifications:

• Experience with other languages such as Python, Go, or C#
• Knowledge of containerization technologies (e.g. Docker)
• Familiarity with clinical diagnostics environment and understanding of Design Control practices as they relate to software development
• Knowledge of security and privacy regulatory frameworks such as ISO27001 and HIPAA

This position is based in Carlsbad, California. ChromaCode is an equal opportunities employer.

If interested, please email resume and cover letter describing your qualifications to:

hr@chromacode.com

We are seeking a senior software engineer with experience developing back end systems to join our growing software team. You will work with the software development team to build out a web-based data analysis platform and associated applications. The position entails the development of web services using a variety of technologies. We are hiring for multiple positions and the seniority/title of the final position will reflect your experience.

Who we are

We are a fast-growing early stage company, passionate about increasing the information content of molecular diagnostics data to drive better decision-making. We use state of the art methods to analyze and improve information content from widely used life science instruments. You will join a team of software developers and scientists in a well-funded, exciting startup environment. We are developing analytical, statistical, and visualization algorithms and implementing tools and software pipelines used to analyze large multidimensional biological datasets, e.g. DNA/RNA data.

What you will be responsible for

• Implementing cloud-based services focusing on scalability and reliability
• Implementing APIs for custom web application and B2B integrations
• Building reusable code and libraries
• Ensuring implementation of security best practices in services and data management
• Package, deploy, and maintain production systems

Your ideal qualifications

You are a collaborative, strong communicator who effectively adjusts to technical and non-technical audiences. You are able to prioritize and deliver results with a high emphasis on quality, technical rigor, and attention to detail. You love working in a fast-paced environment that rewards innovation and creativity.

• 5+ years of professional software development experience
• Strong knowledge of some common languages (Python, Go, Java, C/C++)
• Strong knowledge of (semi-)structured data services (RDBMS, KVS, Doc stores, Index services)
• Strong principles in software design, object-oriented, procedural and event-driven
• Familiarity with Scrum or Kanban to enable effective organization and distributed work
• Strong knowledge of SCM systems (Git) and effective code review techniques

Additional experience (nice to have):

• Experience with authorization frameworks (OAuth2, OIDC)
• Experience with serverless architectures (Lambda, Knative)
• Experience developing public facing APIs and standards (OpenAPI)
• Experience with log aggregation and indexing tools (Splunk, SumoLogic)
• Experience with service observability and monitoring tools (Jaeger, NewRelic)
• Knowledge of application containerization technologies (Docker)
• Experience developing in and contributing to a DevOps culture
• Familiarity with clinical diagnostics environment and understanding of Design Control practices as they relate to software development
• Knowledge of security and privacy regulatory frameworks such as ISO27001 and HIPAA

This position is based in Carlsbad, California. ChromaCode is an equal opportunities employer.

If interested, please email resume and cover letter describing your qualifications to:

hr@chromacode.com

We are looking for a full-time Senior Process Development Scientist. The Senior Process Development Scientist will be responsible for evaluating and developing manufacturing and quality processes to enable scale-up and efficiency improvements, as well as assisting in new process transfer.

Who we are:

We are a company interested in substantially increasing information in multiplexed molecular diagnostics. We leverage novel methods to analyze and enhance information from popular life science instrumentation.

What you will be responsible for:

• Help identify and engineer process improvement projects to increase efficiency in manufacturing and/or testing processes.
• Work with product transfer team and manufacturing to incorporate new processes and procedures for new products.
• Work with Operations Manager to support growth and technical advancement in the department.
• Evaluate and validate secondary vendors. Work with Supply Chain Manager and Purchasing to ensure correct materials are obtained.
• Evaluate potential automation opportunities, seek out automation platforms, and evaluate automation suitability.
• Advise on automation and lab equipment purchases.
• Supervise and perform IQ/OQ/PQ for new technology in manufacturing. Work with Quality to ensure all documentation requirements are met.

Your ideal qualifications:

• S. in Biology, Chemistry, or related physical science with 10+ years of related industrial experience, or M.S. and 6+ years experience.
• Management experience leading manufacturing and/or process improvement teams mandatory, preferably in an IVD environment.
• Experience with RT-PCR mandatory.
• Experience with automated manufacturing systems highly desirable.
• Computer literacy and experience with standard business software packages mandatory. ERP experience highly desired.
• Experience in scientific data analysis, and ability to understand implications of experiments and design relevant subsequent experiments.
• Knowledge of, and experience with, cGMP, ISO 13486, and FDA regulations required.

If interested, please email resume and cover letter describing your qualifications to: hr@chromacode.com

ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at hr@chromacode.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

We are looking for a dedicated Research Associate with expertise in developing novel molecular phenotyping technologies to join a talented team in our advanced technology group. The ideal candidate will contribute to the development of new, high multiplex analyte detection technologies, consistently generate high quality, reproducible data, and be comfortable in a dynamic and fast-paced environment. They will work with scientists, development, software, operations, and business teams to drive the success and impact of novel technologies. The candidate will have incredible enthusiasm for the life sciences, is an organized and effective communicator, and is excited for ChromaCode’s mission.

Who we are:

ChromaCode is a fast-growing life sciences tools company, passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We are currently using our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19.  You will join a team of highly talented scientists and researchers working on really challenging problems in a well-funded, exciting environment.

What you will be responsible to:

• Work both jointly with colleagues and independently to develop, design, and perform experiments to assess new molecular methods for high multiplex analyte detection
• Interpret data and, leveraging your domain knowledge, draw conclusions from experiments to impact project decisions and directions
• Recommend next experimental steps based on results, influencing key project and team directions, and technical approaches to evaluate and implement
• Accurately document and communicate experimental procedures, observations, and insights
• Summarize key data and findings and communicate them to peers through visualizations, reports, and/or presentations

Your ideal qualifications:

• BSc in Biochemistry, Bioengineering, Genetics, Genomics, Molecular Biology, Cell Biology, or related field, or equivalent experience
• 2-5 years of post-undergraduate experience in an experimental lab setting
• Prior experience working with clinical biospecimens (blood, tissue, FFPE, plasma)
• Prior experience with nucleic acid purification and quality control
• Sound understanding of PCR, including PCR assay design and data analysis
• Solid communication skills and ability to interface with other researchers
• Prior expertise developing qPCR and/or digital PCR assays a plus

If interested, please email resume and cover letter describing your qualifications to: hr@chromacode.com

ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at hr@chromacode.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

We are looking for an experienced field market development scientist who will support the go-to-market strategy for all ChromaCode products. We want you to drive product adoption, investigate new opportunities as a partner to sales and marketing and assist as a back-up person in the lab when workload is at capacity. You will be a key member of a cross-functional team ensuring successful product adoption, transfer of scientific knowledge and identification of new opportunities to drive commercial success. This role will also have a Technical Support function associated with the job responsibilities. It is necessary that you are located in the Carlsbad or San Diego County area.

Who we are:

We are a company interested in substantially increasing information in multiplexed molecular diagnostics. We leverage novel methods to analyze and enhance information from popular life science instrumentation.

What you will be responsible for:

• Demonstrating the ChromaCode technology (assay and software) on-site at customer labs
  • Demonstrate product assay workflow and optimize customer workflow
  • Be the resident expert in the field to answer technical questions
  • Present technology to lab personnel and key decision makers
  • Troubleshoot issues on-site
• Develop application notes and white papers to support strategic market development
• Provide technical support to customers via email, telephone, or in person at site visits
• Identify new opportunities in the field for the company technology as part of market development
• Communicate voice of customer (VOC) to the R&D team for product enhancements and new product development by assessing product requirements through customer interaction
• Assisting in lab in-house as needed on assay development or verification and validation projects
• Provide front line technical support tocustomers who may have product questions or require additional assistance
• Perform any technical troubleshooting experiments in lab as needed

Your ideal qualifications:

• Bachelor’s or Master’s in molecular biology, genetics, infectious disease, biomedical engineering, or related field with a minimum of 5 years lab bench experience
• Experience with assay and/or software development life cycle management.
• Experience writing scientific posters, publications and preparing oral presentations
• Demonstrated ability to present to all levels of an organization including the C-Suite
• Experience in regulated (FDA) and non-regulated (life science research) and laboratory-developed test (LDT) environments
• The ability to dialog with customers and internal assay developers at a deep technical level
• Ability to seek out new opportunities in the field and bring forth to sales and marketing teams to work towards a close
• Demonstrated technical ability to understand the products and be able to assist customers as issues may arise

If interested, please email resume and cover letter describing your qualifications to: hr@chromacode.com

We are looking for an experienced field market development scientist who will support the go-to-market strategy for all ChromaCode products. We want you to drive product adoption, investigate new opportunities as a partner to sales and marketing and assist as a back-up person in the lab when workload is at capacity. You will be a key member of a cross-functional team ensuring successful product adoption, transfer of scientific knowledge and identification of new opportunities to drive commercial success.

Who we are:

We are a company interested in substantially increasing information in multiplexed molecular diagnostics. We leverage novel methods to analyze and enhance information from popular life science instrumentation.

What you will be responsible for:

• Demonstrating the ChromaCode technology (assay and software) on-site at customer labs
  • Demonstrate product assay workflow and optimize customer workflow
  • Be the resident expert in the field to answer technical questions
  • Present technology to lab personnel and key decision makers
  • Troubleshoot issues on-site
• Develop application notes and white papers to support strategic market development
• Provide technical support to customers via email, telephone, or in person at site visits
• Identify new opportunities in the field for the company technology as part of market development
• Communicate voice of customer (VOC) to the R&D team for product enhancements and new product development by assessing product requirements through customer interaction
• Assisting in lab in-house as needed on assay development or verification and validation projects

Your ideal qualifications:

• Bachelor’s or Master’s in molecular biology, genetics, infectious disease, biomedical engineering, or related field with a minimum of 5 years lab bench experience
• Experience with assay and/or software development life cycle management.
• Experience writing scientific posters, publications and preparing oral presentations
• Demonstrated ability to present to all levels of an organization including the C-Suite
• Experience in regulated (FDA) and non-regulated (life science research) and laboratory-developed test (LDT) environments
• The ability to dialog with customers and internal assay developers at a deep technical level
• Basic fundamental marketing skills (market analysis, branding, social media, trade show management, advertising, etc.)
• Ability to seek out new opportunities in the field and bring forth to sales and marketing teams to work towards a close

If interested, please email resume and cover letter describing your qualifications to: hr@chromacode.com

We are looking for driven, talented scientist to lead new product introduction efforts of our reagents into manufacturing. The individual will drive new product introduction, and s/he will partner cross-functionally with R&D, Quality, Production, Supply Chain, and other engineering groups to successfully transfer new products into manufacturing.

Who we are:

We are a fast-growing life sciences tools company, passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We are currently using our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19.  You will join a team of highly talented people in a well-funded, exciting environment.

What you will be responsible for:

• Represent operations and process development activities on product core teams.
• Develop and characterize new processes and transfer to manufacturing.
• Work directly with the R&D team in the lab to help develop and characterize robust processes and products.
• Work with suppliers and contract manufacturers to develop incoming material specifications, QC and in-process testing.
• Analyze process test results, issue reports and make technical recommendations.
• Analyze complex data (internal and external) to drive improvements to our products.
• Support manufacturing directly at the low scale, initial launch as needed.
• Running characterization experiments in the wet lab on PCR-based technology

Your ideal qualifications:

• You are a self-driven entrepreneur and problem solver with the ability to advance projects through key milestones.
• Ability to mentor and manage a team to accomplish deliverables
• BA/BS or higher in chemical engineering, bioengineering, biochemistry, or another scientific/engineering discipline with relevant experience
• 6+ years of experience building processes and products in the biotech space
  • Ideally in a regulated environment (design control, ISO 13485, CFR 820)
  • PhD and 3+ years of experience is acceptable
• Wet lab experience with biochemical processes and molecular biology techniques required.
• Experience with statistics, Statistical Process Control and DOE techniques is a highly preferred.
• Experience with production in a high tech consumables industry is a plus.
• High level computer skills are required. Intermediate level programming / data analysis knowledge is desired (JMP, Python or R are preferred).
• Experience with product development processes and project management is a plus.
• Good interdepartmental communication skills and documentation skills are required.
• Demonstrated ability to accomplish goals while working across departments is required.

If interested, please email resume and cover letter describing your qualifications to: hr@chromacode.com

ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at hr@chromacode.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

The Systems Engineering Lead is responsible for driving the creation of requirements, risk file, and system verification & validation activities. He/She is the liaison between functions on the product development core team to realize the commercial product. The individual shall have strong knowledge in design controls, product development processes, requirements creation, risk management activities (plan, analyses, report), design traceability, and verification & validation.

Who we are:

We are a fast-growing life sciences tools company, passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We are currently using our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19.  You will join a team of highly talented people in a well-funded, exciting environment.

What you will be responsible for:

• Single point of accountability for all system requirements, interfaces, specifications and system V&V
• Lead all system and sub-system risk assessment activities including hazard analyses, FMEAs, and residual risk determinations
• Lead verification and validation planning, execution, and reporting including test method development
• Contribute to system architecture design including hardware, software, assay, and reagent components
• Advocate for and drive product usability
• Supports the strategic direction and intent of the product development program (technical judgement)
• Create documentation architecture to ensure appropriate traceability from requirements to risk to V&V
• Familiar with design controls and latest industry standards for product development
• Ensure seamless product transfer to manufacturing
• Active team member and reviewer in technical reviews and presentations
• Assist in the preparation and submission of documentation to regulatory bodies for review
• Clearly communicate results in oral and written presentations
• Orchestrate and lead system integration efforts across assay, software, and hardware teams
• Works with external vendors, partners and service providers to define clear delivery goals, track progress and budget

Your ideal qualifications:

• Bachelor’s degree or higher in Life Science, Engineering, or related field or equivalent work experience is required.
• Minimum of 5-7 years of relevant work experience in scientific or systems engineering product development
• Thorough working knowledge of appropriate regulations and standards, e.g. 21 CFR 820, ISO 13485, FDA, IVDR, CLIA
• Experience in some or all the following disciplines: assay development, PCR, data visualization, and software
• Experience with requirements management tools and building traceability matrices
• Working knowledge of Risk Management (ISO 14971)

• Familiar with auditing, designing, and executing human factors/usability studies in accordance with IEC 62366
• Strong motivational leadership skills and the ability to influence others without direct authority is required
• Exceptional interpersonal and communication skills
• Highly self-motivated individual constantly looking for solutions to design hurdles
• Strong time management and planning skills
• Strong written and oral communication skills
• Demonstrated skills in technical data interpretation and ability to troubleshoot

If interested, please email resume and cover letter describing your qualifications to: hr@chromacode.com

ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at hr@chromacode.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

ChromaCode is looking for an experienced Associate Scientist or Scientist to join our On-Market Engineering team.  To be successful, you’ll need a strong background in molecular diagnostics and a track record of successfully developing or supporting nucleic-acid-based assays.  Experience working with real-time PCR technology is desirable.

The person filling this role will assist the technical support team in troubleshooting products on the market, product improvement, and supporting new assay development as needed.  A sense of curiosity, flexibility, and self-motivation is extremely critical in this role. Working closely with internal cross-functional teams will be essential to success.

Who we are

We are a company interested in substantially increasing information in multiplexed molecular diagnostics. We leverage novel methods to analyze and enhance information from popular life science instrumentation.

What you will be responsible for

• Working closely with multiple departments to troubleshoot field and manufacturing issues
• Design and execute experiments that root cause and provide solutions for ChromaCode Assays and Technology
• Mentor junior member of the team
• Supporting assay development of multiplexed real-time PCR products
• Documentation of work in accordance with ChromaCode’s procedures
• Presentation of results to the On-market Engineering team and broader audiences

Your ideal qualifications

• You are a self-driven problem solver with the ability to advance projects to meet technical needs and you are invigorated by a fast-past work environment
• Independent thinker with strong collaboration skills
• BS in molecular biology or related discipline with 10-13 years of industry experience or an MS in molecular biology or related discipline with 7-10 years of industry experience
• Demonstrated experience in:
  • setting up and running PCR/qPCR assays on commonly used real-time PCR instruments
  • nucleic method extractions in a BSL-2 environment
  • data analysis using JMP, R or other methods
  • PCR/qPCR methodologies
  • scoping or forecasting projects
  • writing Protocols and Reports
• Hands-on experience with digital PCR is desired
• Experience in product support and complaint response is a plus
• Experience on cross-functional teams is a plus

If interested, please email resume and cover letter describing your qualifications to:

hr@chromacode.com

We are looking for a Senior Manager of Front End Application Development to join the Software Engineering team at ChromaCode Inc. A successful candidate will have a proven track record in this or a similar role and will have an enthusiastic entrepreneurial work ethic. This person will be a liaison for the Software Engineering team to the rest of the company and will drive initiatives to meet company goals.

Who we are:

We are a fast-growing life sciences tools company, passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We are currently using our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19.  You will join a team of highly talented people in a well-funded, exciting environment.

What you will be responsible for:

• Oversee development of ChromaCode’s commercial web applications.
• Identify and evaluate key future technologies and work to introduce the technology into the portfolio.
• Support the company’s vision and strategy for its software product lifecycle process and embrace the challenge of technical leadership.
• Promote a culture of teamwork, respect and innovation.
• Collaborate with key stakeholders and influencers in the organization to drive consistency in technical direction.
• Maintain and disseminate current knowledge of information technology and software development trends.

Your ideal qualifications:

• 10+ years of hands-on experience developing large software applications and solutions. Specific experience in Web Application Development, Cloud, AWS required.
• Strong knowledge of client-side scripting and JavaScript frameworks (e.g. React, Redux, Node.js).
• Experience with a broad range of technologies and architectures including: client/server architectures, enterprise architectures, containerization technologies (e.g. Docker), distributed architectures, and web deployments.
• Experience with other languages such as Python, Go, or C#.
• Extensive knowledge of security and data privacy best practices and relevant technologies.
• Strong experience in iterative software development life cycle and quality.
• Experience working in regulated space (preferably GxP).
• Excellent communication skills, verbal and written, with technical and executive audiences.
• Highly motivated, self-confident leader with a collaborative, open management style that fosters participation and contribution by others.
• A college degree, preferably related to engineering or software development.

If interested, please email resume and cover letter describing your qualifications to: hr@chromacode.com

ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at hr@chromacode.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

We are looking for a full-time Process Development Manager. The Process Development Scientist will be responsible for evaluating and developing manufacturing and quality processes to enable scale-up and efficiency improvements, as well as assisting in new process transfer.

Who we are:

We are a company interested in substantially increasing information in multiplexed molecular diagnostics. We leverage novel methods to analyze and enhance information from popular life science instrumentation.

What you will be responsible for:

• Help identify and engineer process improvement projects to increase efficiency in manufacturing and/or testing processes.
• Work with product transfer team and manufacturing to incorporate new processes and procedures for new products.
• Work with Operations Manager to support growth and technical advancement in the department.
• Evaluate and validate secondary vendors. Work with Supply Chain Manager and Purchasing to ensure correct materials are obtained.
• Evaluate potential automation opportunities, seek out automation platforms, and evaluate automation suitability.
• Advise on automation and lab equipment purchases.
• Supervise and perform IQ/OQ/PQ for new technology in manufacturing. Work with Quality to ensure all documentation requirements are met.

Your ideal qualifications:

• S. in Biology, Chemistry, or related physical science with 10+ years of related industrial experience, or M.S. and 6+ years experience.
• Management experience leading manufacturing and/or process improvement teams mandatory, preferably in an IVD environment.
• Experience with RT-PCR mandatory.
• Experience with automated manufacturing systems highly desirable.
• Computer literacy and experience with standard business software packages mandatory. ERP experience highly desired.
• Experience in scientific data analysis, and ability to understand implications of experiments and design relevant subsequent experiments.
• Knowledge of, and experience with, cGMP, ISO 13486, and FDA regulations required.

If interested, please email resume and cover letter describing your qualifications to: hr@chromacode.com

ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at hr@chromacode.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

We are seeking a highly motivated and experienced Director/Senior Director of Research and Development to join the ChromaCode team developing molecular diagnostic products. The primary focus is to use our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19, infectious disease, oncology, and other potential molecular diagnostic innovations. The qualified candidate will lead a Research Development team focused on new product development. This position will work cross-functionally across Software, Data Science, Manufacturing, and Commercial teams to develop and provide next-generation PCR-based diagnostics. Must be comfortable working in a fast-paced environment and flexible to changing priorities. Title is dependent on experience.

Who we are:

We are a fast-growing life sciences reagents and software company passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We are currently using our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19.  You will join a team of highly talented people in a well-funded, exciting environment.

What you will be responsible for:

• Lead a team or multiple teams of Scientists to solve complex issues that require an in-depth understanding of molecular biology and statistics.
• Act as the subject matter expert on core teams, working with the core team to deliver quality products on accelerated timelines.
• Provide scientific guidance on study design and executions for crucial projects.
• Quickly learn and apply new tools, processes, and standards. Demonstrate adaptability and forward-thinking in the face of technological or organizational change
• Provide clear communications to the development team, other functional areas, and to executives
• Manage relationships with key third-party collaborators and vendors.

Your ideal qualifications:

• MS (ten years minimum) or Ph.D. (six years minimum) with direct responsibility for leading development teams.
• Demonstrated success in delivering molecular diagnostic products under design control process, including authoring design documentation, leading core teams
• Strong problem-solving skills and demonstrated knowledge of PCR and/or other nucleic acid amplification technologies.
• Ability to work and communicate across departments.
• Well organized, detail-oriented, ability to influence and adaptable to change.
• Excellent communication and presentation skills
• Experience in launching IVD products is a must.
• Experience in oncology, NIPT and infectious disease molecular diagnostics is a plus.
• This position will be based in Carlsbad, California

If interested, please email resume and cover letter describing your qualifications to: hr@chromacode.com

ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at hr@chromacode.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

Looking for an Associate Director leading the Life Cycle Management group at ChromaCode. The ideal candidate will work in a dynamic, team-oriented environment to help manage the on-market lifecycle of our products, including product transfer, on market product engineering, and new product introduction to manufacturing.

Who we are:

We are a fast-growing life sciences tools company, passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We are currently using our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19.  You will join a team of highly talented people in a well-funded, exciting environment.

What you will be responsible for:

• Group leadership and team growth
• Lead the product transfer efforts to get products from R&D
• Lead implementation of new products into manufacturing
• Improve on-market products through leading the development of expansion of capabilities (e.g. new sample types, new instrumentation etc)
• Drive qualification of second source materials to reduce supply chain risk
• Oversee product design transfer to manufacturing and implementation
• The team will author process verification test plans and oversee execution
• The team will design experiments, analyze results and share findings through written reports and group presentations
• Work effectively with cross-functional project teams
• Troubleshoot and resolve field performance issues

Your ideal qualifications:

• PhD in relevant field (Bioengineering, Chemical Engineering, Biochemistry, Analytical Chemistry, Biology, etc.) and at least 6 years experience in a related industry or
  BS/MS in relevant field and at least 10 years experience in a related industry
• Complex system troubleshooting skills
• A desire to be a part of a fast-paced, collaborative and multidisciplinary environment.
• A history of managing and coaching high performers to achieve even greater success
• Wet laboratory & biochemistry/chemistry experience desired
• Thorough working knowledge of appropriate regulations and standards, e.g. 21 CFR 820, ISO 13485, FDA, IVDR, CLIA
• Experience in some or all the following disciplines: assay development, PCR, data visualization, and software
• Familiarity with design control process
• Understanding of PCR technology and applications
• Capability to analyze large, complex datasets
• History of leading teams in a matrix environment
• Track record of innovation

If interested, please email resume and cover letter describing your qualifications to: hr@chromacode.com

ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at hr@chromacode.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

ChromaCode is looking for an exceptional Clinical/Scientific Affairs professional to spearhead the establishment of these functional areas at ChromaCode. To be successful, you’ll need the mentality to thrive in ambiguity, a track record of developing successful processes from scratch, and the ability to execute with minimal supervision. Experience working with real-time and digital PCR technology is a major plus.

The person filling this role will have proven experience in cross-functional alignment.  You will work cross-functionally across the organization and will be the liaison to partner CROs.

Who we are

We are a well-funded, multiplexed molecular diagnostics start-up with a bioinformatics focus and pedigree from Illumina, Google[x], Luminex, and Caltech. We leverage patented mathematical methods and algorithmic enhancements to enrich signal processing from the most popular life science instrumentation.  We are using this to extract new information on biochemistry reactions and substantially increase the performance capabilities of today’s gold-standard biochemical assays at a very low cost.

What you will be responsible for

• Creating, authoring, and implementing processes/area SOPs for Clinical Affairs and Scientific Affairs
• Collaborating with Regulatory and liaise with partner CROs in the design and execution of clinical trials, including adherence to GCP
• Clinical Affairs core team representation
• Writing scientific communications, including white papers, abstracts, data summaries, and publications, interfacing with KOLs
• Work with the R&D team to ensure procurement of specimens for development & internal verification studies
• Lead the clinical sample management team to ensure the sample needs of internal and external testing are met
• Supporting study execution for alpha/beta testing sites, as well as external verification sites
• Collaborate with the Scientific Affairs Committee to design and support studies to meet commercial operations needs
• Collaborates with Legal and Regulatory to ensure NDAs, proper contracting, and financial agreements for external studies

Your ideal qualifications

• A BS, MS, or PhD in the Life Sciences (Biology, Molecular Biology, Biochemistry) or another relevant field
• Five or more years in Clinical Affairs with demonstrated increasing responsibilities including study design, contracting, budgeting, monitoring, and creative contingency planning
• Minimum 3 years of supervisory experience
• Extremely organized, results oriented, and energized by a fast-paced environment
• Highly collaborative and driven to understand organizational needs to set the team up for success
• Strong communication skills – oral and written – to enable meaningful and timely dissemination of scientific study results to a variety of audiences including internal stakeholders, trade show talks, abstracts, webinars and posters
• Experience in analysis of complex data sets
• Experience working in a startup environment
• This position will be based in Carlsbad, California

If interested, please email resume and cover letter describing your qualifications to:

hr@chromacode.com

We are seeking a highly motivated and experienced Director, Quality Engineering to join the exciting area of molecular diagnostic products. The primary focus is to use our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19, infectious disease, oncology, and other potential molecular diagnostic innovations. This qualified candidate will build and oversee the product development quality team to ensure programs are resourced and supported appropriately. This role is responsible for setting the quality expectations across products to build a high level of consistency and efficiency, applying quality engineering, design control and risk management principles to achieve the development of high quality diagnostic products, including software, and customer satisfaction that will improve patient outcomes. This individual will have overall responsibility for leading the improvements and management of the design control quality processes, including setting related quality goals and metrics to ensure compliance. In this hands-on role, the individual will work closely with the regulatory, engineering, marketing, project management, operations, and commercial teams to maintain compliance to 21 CFR 820 and ISO 13485 and to also support development of research use products. The ideal candidate should be strategic, able to work in a fast-paced work environment, flexible, analytical, able to lead and motivate teams, as well as run independently. This is an exciting opportunity for a passionate, hands-on, data-driven, ambitious individual who thrives in a dynamic environment.

Who we are:

We are a fast-growing life sciences reagents and software company, passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We are currently using our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19.  You will join a team of highly talented people in a well-funded, exciting environment.

What you will be responsible for:

• Provide quality engineering support for new product development from feasibility through clinical and into commercialization, including lifecycle management, to ensure design control requirements are met.
• Work effectively and guide multiple functions (R&D, Operations, Commercial, Regulatory, Supply Chain, Clinical, etc.) to ensure design control expectations are met and understood at the team and management levels.
• Lead initiative to refine design control and risk management activities according to 21 CFR 820, ISO 13485, and ISO 14971, and further develop processes that ensure compliance, agility, and consistency across products. Drive continuous improvements in this area.
• Support medical device software product development and align design controls with overall product development.
• Lead initiative to refine software design controls, specifically for verification/validation, risk management, and lifecycle management.
• Provide quality oversite and collaboration regarding risk management activities, including hazards identification, risk assessment (FMEA), and mitigation under normal and challenging conditions.
• Review/approve design control and risk management activities. Work closely with research and development, as well as operations to ensure potential product issues are identified and addressed during device design.
• Review/approve quality issues (e.g. deviation, investigations), technical matters (e.g. design changes, verification and validation), and their resolution, considering impact to design controls and risk management.
• Advise and educate technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.
• Partner/collaborate with potential 3rd parties who impact product development activities, such as review of 3^rd party’s quality system and their design control deliverables, assessment of supplier changes, supplier controls (corrective actions), quality agreements, relationship development, etc., as related to product development.
• Work on complex technical problems, utilize quality engineering methods and provide innovative solutions. Support resolution of project team issues with minimal oversight.
• Provide consultation and training on design controls to internal and cross-functional groups.
• Represent the company as the quality engineering product development subject matter expert during internal and external regulatory inspections.
• Review/approve design verification plans, validation protocols, reports, and trace matrices as part of design controls to ensure robust product development deliverables that support quality, approvable products.
• Review and approve product specifications
• Key performance indicators: On-time delivery of owned QE activities (i.e., product development quality deliverables, supplier collaboration/relationship management, design control SOP improvements, etc.) and implementation of quality key performance indicator (KPI) improvements as determined through Quality Planning.

Your ideal qualifications:

• Bachelor’s Degree in sciences, engineering or other technical/scientific area
• 10+ years in medical device and/or pharma quality product development
• 2+ years of people management experience
• Understanding of software medical device regulations and guidance
• Experience with 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, Human factors Engineering and other standards and FDA guidance as related to medical device product development
• Hands on experience with design controls, including verification and validation, software, and risk management
• Experience with contract manufacturers, supplier management/relationships as related to product development
• Experience with 2^nd and 3^rd party quality audits
• Ability to resolve unusually complex technical problems by providing risk-based solutions that are highly innovative and strategic
• Conflict resolution skills and ability to negotiate positions based on clear technical justifications
• Ability to respond quickly to unplanned events, technical issues and changing needs from development programs by making sound quality judgment from complied factual data provided by the various functional areas, each presenting varied viewpoint of regulatory requirements or project needs and requirements
• Strong oral and written communication skills needed
• Excellent interpersonal skills required

If interested, please email resume and cover letter describing your qualifications to: hr@chromacode.com

ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at hr@chromacode.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

We are seeking a highly motivated and detail-oriented Manager, Quality Assurance (QA) to join the exciting area of molecular diagnostic products and oversee manufacturing QA. The primary focus is to use our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19, infectious disease, oncology, and other potential molecular diagnostic innovations. The qualified candidate will oversee a team for manufacturing QA and implementation of processes to build efficiency, with a heavy emphasis on inspection, instrument and equipment validation, quality control testing, deviation and resolution, and documentation activities to support manufacturing and quality management systems (QMS) compliance. The candidate will provide both oversight and hands-on manufacturing QA and QMS leadership and support. Such activities include ensuring team is trained in QA review activities and collaborating effectively, and ensuring completing of batch records, document maintenance, and archiving of electronic and paper-based quality records.

Who we are:

We are a fast-growing life sciences reagents and software company, passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We are currently using our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19.  You will join a team of highly talented people in a well-funded, exciting environment.

What you will be responsible for:

• Oversee and support the following quality manufacturing activities from incoming inspection to product release and ensure the team is trained and grows in knowledge and capability in these areas.
  • Ensure incoming material/component inspection and release is conducted.
  • Ensure in-process and finished product inspection is conducted.
  • Review and approval of batch record and test report reviews
  • Ensure calibration/maintenance of instrumentation and are maintained.
  • Issuing controlled batch record and test records.
  • Ensure batch records are archived as quality records.
  • Issuance, verification, and archival of laboratory cleaning logs.
  • Ensure line clearance activities are completed as part of manufacturing.
• Ensure device master records (DMR) are complete and archived. This includes generating device master record index (DMRI).
• Ensure compliance and inspection readiness of design and manufacturing areas with applicable regulatory standards.
• Review and approve new Work Instructions (WI) and Test Instructions (TI), as well as WI and TI revisions.
• Review and approve Manufacturing Specifications.
• Review/approve manufacturing deviations/non-conformances, related re-work and action requests, and resolution.
• Organize coordination of quality activities with manufacturing related suppliers and consultants to ensure timely delivery and compliance.
• Interface with contract manufacturers and manage quality related responsibilities related to contract manufacturing
• Strategize and collaborate on lean manufacturing initiatives and support development and manufacturing processes.
• Support development of QC test methods according to technical standards.
• Guide the conceptualization of new methodologies, materials, machines, processes or products.
• Drive use of appropriate statistical methods, quality tools and computer-generated reports to continuously improve process capabilities.
• Ensure on-time delivery of manufacturing/test records per manufacturing plan.
• Provide metrics, as well as track and trend for continuous improvement.
• Serve as subject matter expert for manufacturing QA in audits and inspections.
• Provide input into Quality Plan and Management Review, as related to manufacturing QA.
• Support product development quality engineering counterpart, specifically regarding process validation and design transfer, to ensure design control requirements are met.
• Implement of quality key performance indicator (KPI) improvements as determined through Quality Planning.

Your ideal qualifications:

• Bachelor’s Degree or Minimum 4 Years Experience Working in Medical Device Quality Assurance
• 2+ years working with Quality Systems within a regulated environment (medical device or pharmaceutical)
• 1+ years people management experience
• Knowledge of 21 CFR Part 820, ISO 13485 and familiarity with ISO 14971
• Experience with manufacturing QA management and deployment
• Must have excellent oral and written communication, presentation, and interpersonal skills
• Previous experience with process development
• Medical device audit/inspection experience
• Must provide a high level of partnership and cross-functional collaboration
• Sophisticated organizational skills, attention to detail, and the ability to balance multiple assignments is required
• Excellent interpersonal skills
• Requires high level of competence, confidence, and credibility
• Requires conflict resolution skills, including persuasive management techniques
• Strong oral and written communication skills needed
• Critical thinker, detailed oriented, organized, and collaborative skills.
• Ability to work in a self-directed environment and team environment.
• Software application knowledge; eQMS platforms, Microsoft Professional Office Suite (MS Word, MS Excel, MS Outlook, MS Access).
• ASQ certification and/or Six Sigma training
• Must be capable of working in a laboratory environment including appropriate personal protective equipment.
• Capable of lifting 50 pounds as required.

If interested, please email resume and cover letter describing your qualifications to: hr@chromacode.com

ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at hr@chromacode.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

ChromaCode is looking for an experienced Scientist/ Associate Scientist to support some of our most critical assay development efforts.  We want you to build multiplexed assays for real-time PCR instruments.  To be successful, you’ll need a strong background in molecular diagnostics and a track record of successfully developing nucleic-acid-based assays.  Experience working with real-time and digital PCR technology is a major plus.

The person filling this role will assist in supporting products on the market, product improvement, transfer activities to manufacturing, and supporting new assay development as needed.  A sense of curiosity and flexibility is extremely helpful in this role. Working closely with internal cross-functional teams will be essential to success.

Who we are

We are a well-funded, multiplexed molecular diagnostics start-up with a bioinformatics focus and pedigree from Illumina, Google[x], Luminex, and Caltech. We leverage patented mathematical methods and algorithmic enhancements to enrich signal processing from the most popular life science instrumentation.  We are using this to extract new information on biochemistry reactions and substantially increase the performance capabilities of today’s gold-standard biochemical assays at a very low cost.

What you will be responsible for

• Execution of laboratory work in support of molecular diagnostic product development
• Provide day to day guidance to junior team members
• Supporting assay design of multiplexed real-time and digital PCR products
• Documentation of work in accordance with ChromaCode’s procedures
• Writing protocols and reports for analytical verification studies
• Quantitative data analysis of experiments
• Presentation of results to the assay team

Your ideal qualifications

• You are a self-driven problem solver with the ability to advance projects to meet technical specifications
• BS/MS in molecular biology or related discipline with 10+ years of industry experience or PhD with 0-2 years of industrial experience.
• Experience setting up and running PCR/qPCR/dPCR assays on commonly used real-time PCR instruments
• Experience with nucleic acid extraction methods from human blood, plasma, nasal pharyngeal or other sample types in BSL-2 environment
• Bioinformatics, quantitative analysis and statistical knowledge a plus
• Strong technical background in molecular biology and troubleshooting skills are required
• Knowledge of real-time PCR and other amplification methodologies
• Experience in product development under QSR/Design Control
• Experience in developing diagnostic assays
• Ability to work both independently and as part of a team
• Good interdepartmental communication skills and documentation skills are required
• Experience analyzing data with Python, JMP or R a plus

If interested, please email resume and cover letter describing your qualifications to:

hr@chromacode.com