Sr. Development & Transfer Scientist, Focus Diagnostics
As part of the Quest Diagnostics family, Focus Diagnostics, Inc. is committed to providing proven and reliable products its customers have grown accustomed to throughout the years. Since its founding in 1978, Focus Diagnostics has grown its business from specialized laboratory testing to manufacturing its high-quality laboratory tests for hospitals and commercial laboratories worldwide. These manufactured tests are built in response to diagnostic testing trends identified and evaluated by Focus Diagnostics and used in Quest Diagnostics’ national laboratories.
The Sr. Development and Transfer Scientist will be the technical partner to the R&D teams responsible for successful design for manufacturability and manufacturing transfer of new products. Daily interaction and heavy engagement with R&D, Manufacturing Engineering, Manufacturing, Quality Engineering and other functions within Focus is expected of the scientist in this role. Uses professional concepts and relationships to contribute to the development and completion of company goals and objectives in creative and effective ways. Supports all applicable regulations including, but not limited to, FDA and ISO requirements.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Actively participate in the development of new products as a representative of Product Transfer and Operations to ensure compatibility with current and future manufacturing processes and capabilities.
- Partner with the R&D team to assess manufacturability throughout the life cycle of new products.
- Conduct design for manufacturability testing and review meetings routinely.
- As appropriate, serve as a technical liaison for other departments with regards to new product introduction activities, including, but not limited to, bill of materials, reference material, reagent formulation, and product or consumables testing.
- Lead, coordinate, or participate in operations-related activities required for the successful transfer of new products to routine production including production scale-up, process development/optimization and technology transfer.
- Assist manufacturing teams with process validation and test method validation studies.
- Develop production documentation including procedures, worksheets, and bills of materials.
- Maintain substantial and current knowledge of validation and process control requirements mandated by applicable regulatory bodies.
May direct an individual technician or a group of scientists and technicians. Works with other departments through matrix reporting to ensure development projects are effectively managed during the product development process.