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
M.S. in a Life Sciences Discipline (Biochemistry/Immunology/Pathology/Molecular Biology). PhD preferred, or equivalent 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).
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 firstname.lastname@example.org with any questions.