Job Description
Who we are
At Roche, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.
The Position
Responsible for the direction, planning and execution of research and development activities for the new product development, new product planning, critical reagent development and validation and project management. ESSENTIAL FUNCTIONS: - New Product Development – Conducts feasibility studies. Develops reagents within F8 design control process and oversees validations. Oversees research and development of new products, as well as the transfer of products to Operations. Directs studies for Marketing and FDA approval and ensures GMP, ISO and IVDD complaint documentation.- New Product Planning – Interacts with Marketing to set product specifications, timing, resources and provide technical expertise. - Oversees the critical reagent development, validation and transfer to Operations.- 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 Quality First Time.
Who you are
Formal Training/Education:Ph.D. in a Life Sciences Discipline (Biochemistry/Immunology/Pathology/ Molecular Biology). Experience:10 years combined academic and industry with direct experience in an IVD company. Experienced working with Marketing, Quality Assurance and Operations. 5 years of management experience. Demonstrated record of accomplishments (e.g., publications in scientific journals, issued US patents).Knowledge, Skills and Abilities:- Strong background in assay development, including immunoassay and immunohistochemistry or in situ hybridization and nucleic acid detection.- Knowledge of Cell/Molecular Biology, Pathology or Cancer Biology.- Experience 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.
Roche is an Equal Opportunity Employer
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