The Sr. Manager, Technical Transfer will have leadership responsibility in planning and oversight for transfer of products developed in the Genetic Testing Solutions (GTS) Business to manufacturing. As part of the Operations team within the Genetic Sciences Division of Thermo Fisher Scientific, the successful candidate will lead efforts for process development, pilot manufacturing and operations transfer of genetic testing solutions products. This individual will form and manage the new GTS Technical Transfer team, provide technical leadership, serve as the subject matter expert on project teams and work closely with other cross-functional groups on new product introduction and continuous improvement activities. The candidate will monitor, explore and evaluate new technologies to continuously improve transfer quality and time.
What will you do?
- Lead and manage development and growth of the Technical Transfer team
- Participate in product architecture and design activities, support risk analysis, integration and testing activities
- Plan and execute experiments that involve multiple chemistry and molecular biology disciplines to optimize new product formulations and manufacturing processes
- Work with development scientists and engineers to establish formulation and testing protocols and translate to standard operating procedures
- Set up product infrastructure including raw material, intermediate and finished goods specifications
- Lead development of supplier partners to support successful component development
- Conduct tech transfer activities including process characterization and scale up
- Lead product transfer to manufacturing and support commercialization of the product/process
- Support manufacturing and quality in problem solving production issues and deviation investigations
How will you get here?
- Successful candidates will have educational background in chemical engineering, molecular biology, bioengineering or similar field.
- Typically requires a Bachelor’s degree with 8-12 years’ experience, or Masters with 6-10, or PhD with 4-7 years of work experience.
- Experience required in both, Development (new product introduction) and Operations settings, preferably with experience commercializing products in a fast-paced Biologics, Chemistry or Molecular Biology environment.
- Track record in successfully developing and managing R&D, Tech Transfer or Manufacturing teams required.
- Experience with regulated product development, transfer and support is a plus