Director Senior, tRED Antibody Innovation
United States, California, Pleasanton
Responsible for the direction, planning, execution and continuous improvement of research and development activities for new product and technology planning, critical reagent development and validation and project management.
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 studies for Marketing and FDA approval and ensures GMP, ISO and IVDD compliant documentation.
New Product Planning – Interacts with Marketing and Product Development teams to set product specifications, timing, resources and provide technical expertise.
Oversees the critical reagent development, validation and transfer to Operations.
Project Management – Oversees Antibody Innovation commitments and workstreams within cross-functional teams engaged in the development, commercialization and on-market support of critical reagent applications and new product development.
Contributes to and drive execution of tRED technology strategies, roadmaps and strategic capabilities. Addresses strategic and technical issues; prepares departmental budgets; monitors and manages department infrastructure, operations and spending.
Directs departmental staff including: interviewing and hiring staff, providing performance feedback and reviews, counseling, coaching and developing, rewarding, completing progressive disciplinary and terminating.
Monitors work to ensure quality, and continuously promote Quality First Time.
Oversees implementation of continuous improvement, R&D Lean and best practices (standard work) to drive quality, speed, productivity and efficiency, in alignment with departmental strategy and objectives.
Ph.D. in a Life Sciences Discipline or related Computational Biology/Bio-Engineering disciplines (Biochemistry/Immunology/Pathology/Molecular Biology etc).
15 years combined academic and industry with direct experience in an IVD company. Experienced working with Marketing, Quality Assurance and Operations. 10 years of management experience. Demonstrated record of accomplishments (e.g., publications in scientific journals, issued US patents).
Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digitalpathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics.
For more information and to apply, please click here.
Job posted: April 26, 2018