Director of Assay Development, Molecular Diagnostics

An exciting new diagnostic company based on a next-generation CRISPR and synthetic biology technology platform is seeking an outstanding Director of Assay Development to lead product development teams to engineer and launch molecular diagnostic products. The successful candidate will be responsible for strategic direction of new products, planning and execution of research and development activities. In addition, the successful candidate will help drive the innovation of the platform and translate improvements into new products. This role provides strategic and technical leadership in defining and achieving product development objectives while ensuring compliance with health authority requirements. The Director of Assay Development is also responsible for partnering with life cycle teams and internal as well as external business partners to drive product development. This role will drive continuous improvement within product development processes and manage resources to achieve business results within budget. Successful candidates will join an exciting and fast-paced team focused on improving human health worldwide through a highly innovative CRISPR-based platform for molecular diagnostics.

Duties and Responsibilities include:

  •  New Product Planning – Interacts with Marketing to set product specifications, timing, resources and provide technical expertise.

  •  Oversees critical reagent development, validation, and transfer to Operations.

  •  Project Management – Oversees the management of cross-functional teams in the development and commercialization of reagent applications and new product development.

  •  New Product Development – Conducts feasibility studies. Develops reagents within design control process and oversees validations. Oversees research and development of new products, as well as the transfer of products to Operations.

  •  Directs analytical studies for Marketing and FDA approval and ensures GMP, ISO and IVDD compliant documentation.

  •  Addresses strategic and technical issues; prepares departmental budgets; monitors department spending.

  •  Directs departmental staff including: interviewing and hiring staff, providing performance feedback and reviews, counseling, developing, rewarding, completing progressive disciplinary and terminating.

  •  Monitors work to ensure quality, and continuously promote First Time Quality.

  •  Responsible for employee development including leaders and all level of scientists in the organization. Responsibilities also include developing workforce planning models and developing skills sets within team to meet future technology requirements

Minimum Qualifications:

M.S. in a Life Sciences Discipline (Biochemistry/Immunology/Pathology/Molecular Biology). PhD preferred, or equivalent experience.

Experience:

  •  With MS in Life Sciences: Eight (8) years combined academic and industry with direct experience in an IVD company.

  •  With PhD in Life Sciences: Six (6) years combined academic and industry with direct experience in an IVD company.

  •  4 years of management experience.

  •  Experience working with Marketing, Quality Assurance and Operations.

  •  Demonstrated record of accomplishments (e.g., publications in scientific journals, issued US patents).

Preferred Qualification:

8+ years of management experience

Knowledge, Skills, and Abilities:

  • Strong background in assay development, including immunoassay and immunohistochemistry or in situ hybridization and nucleic acid detection.

  • Demonstrated knowledge of cell biology, pathology, histology, molecular biology, chemistry, or biochemistry. Experience with immunohistochemistry preferred. Must demonstrate technical aptitude to learn different scientific applications quickly.

  • Experienced in IVD product development and FDA submissions.

  • Excellent leadership and communication skills, creative problem solver especially in technical areas.

  • Familiarity with the various regulatory requirements (GMP, ISO and IVDD).

  • Must work well with cross functional teams.

Please reach out to crisprdx@gmail.com with any questions.

Scientist I, Molecular Diagnostics

An exciting new diagnostic company based on a next-generation CRISPR and synthetic biology technology platform is seeking an outstanding scientist to work as part of a product development team to engineer and launch molecular diagnostic products across a range of impactful healthcare applications. The successful candidate will contribute to new product initiatives through requirement definition, prototype design, reaction optimization, verification, validation, and assay troubleshooting.

The ideal candidate will have prior experience designing, developing, testing, implementing, and supporting molecular diagnostics assay workflows using a requirement-driven approach – equivalent academic experience is highly valued and will qualify. Experience working on cross-functional teams to apply scientific methods and product/process design principles in establishing and improving quality control and manufacturing processes is a plus. Successful candidates will join an exciting and fast-paced team focused on improving human health worldwide through a highly innovative CRISPR-based platform for molecular diagnostics.

Duties and Responsibilities Include:

  •  Provides substantial, high-quality contributions to projects by working independently and leveraging the active support of others.

  •  Independently identifies and utilizes relevant internal documentation and external publications to optimize procedures and processes.

  •  Creative problem solving and critical thinking skills for addressing technical issues during assay development

  •  Proactively and effectively interacts with counterparts across one or more departments to support achievement of project goals.

  •  Helps to design guard-banding parameters, verification tests and validation experiments

  •  Performs primary data analysis of results, and provides substantial contributions to internal technical reports and design documentation

  •  Writes and reviews experimental protocols and Standard Operating Procedures, incorporating input from other team members efficiently and effectively

  •  Performs molecular laboratory methods including nucleic acid extraction, reverse transcription, quantitative PCR, and various other molecular diagnostic technologies.

  •  Participates in cross-functional process development and improvement teams focused on improving efficiency, throughput, cost, and quality

Minimum Qualifications

  •  Master’s degree (+1 year relevant experience) or Bachelor’s degree (+3 years relevant experience) in molecular biology, biochemistry, bioengineering, biomedical engineering, chemical engineering, or a closely-related discipline is required; PhD preferred.

  •  Experience with data analysis, maintenance of data quality and technical troubleshooting.

Experience

  •  Demonstrated ability to contribute effectively to cross-functional process development, improvement, and troubleshooting teams.

  •  Strong written and oral communication skills with demonstrated track record of successful communication with internal teams and managers.

  •  A track record of successfully completing assignments and meeting goals within aggressive timelines.

  •  Knowledge of statistical process control charts and data interpretation.

  •  Excellent organizational and planning skills.

Please reach out to crisprdx@gmail.com with any questions.

Research Technician, Molecular Diagnostics

An exciting new diagnostic company based on a next-generation CRISPR and synthetic biology technology platform is seeking an outstanding technician to work as part of a dynamic team to develop and launch molecular diagnostic products. The successful candidate will execute studies, conduct data analysis, and document results. This role will interact with other groups and functionalities in the research and product development teams. Successful candidates will join an exciting and fast-paced team focused on improving human health worldwide through a highly innovative CRISPR-based platform for molecular diagnostics.

Responsibilities:

  • Contributes to experimental design, data analysis, critical thinking, and problem-solving to improve methods or procedures.

  • Conducts laboratory and study activities according to approved study protocols, Standard Operating Procedures (SOPs), and Work Instruction Documents (WIDs) to maintain the safety of self and colleagues and the integrity of the data collected.

  • Proficient at carrying out assignments with general guidance in planning, organizing and meeting deadlines.

  • Supports an atmosphere of inclusion and collective contribution to projects and procedures with team. Communicates regularly with supervisor to relay project progress, experiment results, and data analysis, and discuss challenges

  • Good documentation is essential to this position and includes recording all work, notebooks and other documentation for assigned projects/experiments

Skills and Experience:

  •  B.S or M.S. degree in Biology, Biochemistry, or related field or comparable industry experience

  •  0-2 years industry experience (IVD a plus)

  •  Knowledge and laboratory experience with molecular biology techniques. Strong analytical and quantitative skills.

  •  Excellent oral and written communication skills

  •  Capable of adjusting to dynamic working environment and changing priorities, while ensuring timely completion of assigned tasks

Please reach out to crisprdx@gmail.com with any questions.

Scientist I, Molecular Diagnostics Platform Innovation

An exciting new diagnostic company based on a next-generation CRISPR and synthetic biology technology platform is seeking an outstanding scientist to work as part of a creative team dedicated to feature development and expansion of a leading molecular diagnostic technology platform. The successful candidate will contribute to driving the technology forward through innovations that will boost overall performance and robustness of the company’s CRISPR diagnostic platform.

The ideal candidate will have prior experience designing, developing, testing, implementing, and supporting molecular diagnostics assay workflows in a research or industrial environment. Experience working on diagnostics, in particular platform technologies, on cross-functional teams with success translating developments into product features is highly valued. Successful candidates will join an exciting and fast-paced team focused on improving human health worldwide through a highly innovative CRISPR- based platform for molecular diagnostics.

Duties and Responsibilities Include:

  •  Provides substantial, high-quality contributions to projects by working independently and leveraging the active support of others

  •  Independently identifies and utilizes relevant internal documentation and external publications to optimize procedures and processes

  •  Proactively and effectively interacts with counterparts across one or more departments to support achievement of project goals

  •  Creative problem solving and critical thinking skills for addressing technical issues during assay development

  •  Helps to design effective protocols to rapidly improve overall diagnostic performance

  •  Develops methods to translate platform improvements into solutions for IVD products that can be scaled for manufacturing

  •  Performs molecular laboratory methods including nucleic acid extraction, reverse transcription, quantitative PCR, and various other molecular diagnostic technologies.

Minimum Qualifications

  •  Master’s degree (+1 year relevant experience) or Bachelor’s degree (+3 years relevant experience) in molecular biology, biochemistry, bioengineering, biomedical engineering, chemical engineering, or a closely-related discipline is required; PhD preferred

  •  Experience with optimizing molecular diagnostics techniques

  •  Experience with data analysis, maintenance of data quality and technical troubleshooting

Experience

  •  Demonstrated ability to contribute effectively to cross-functional process development, improvement, and troubleshooting teams

  •  Strong written and oral communication skills with demonstrated track record of successful communication with internal teams and managers

  •  A track record of successfully completing assignments and meeting goals within aggressive timelines

  •  Knowledge of statistical process control charts and data interpretation

  •  Excellent organizational and planning skills

Please reach out to crisprdx@gmail.com with any questions.