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|Sr Staff Manufacturing R&D Scientist|
Company: Thermo Fisher Scientific
Location: Princeton, NJ
Employment Type: Full Time
Date Posted: 10/17/2020
Expire Date: 12/06/2020
Job Categories: Biotechnology and Pharmaceutical, Customer Service and Call Center, Information Technology, Manufacturing and Production, Science, Research & Development
Sr Staff Manufacturing R&D Scientist|
Title: Sr Staff Manufacturing R&D Scientist
The individual will be the primary technical liaison between the Manufacturing Sciences (MS) group and the manufacturing/operations group. The scientist will provide the formulation, manufacturing, and operations group with technical support during manufacturing/compounding of sterile pharmaceutical products.
The scientist will support the generation and review of protocols, work orders/batch records, and technical summary documents to support the timelines of individual projects.
The scientist will support the investigation and documentation of any deviations in conjunction with the assigned projects. The scientist may participate in technical discussions with clients with a high level of technical proficiency.
The scientist will support the implementation of new technologies, component systems, change parts, and other process related activities to support ongoing and new projects. This work may include process improvement activities, filling line transfers, and other activities that would be project driven.
The scientist will provide mentoring and guidance to other scientist with regard to client intractions
The scientist will have to make decisions that will support both client requests, adherence to the rules of GMP’s and support the goals of the project.
The Scientist will:
Works closely with site management to optimize requirements of both client and site for portfolio of projects. Leads development and coordination of realistic proposals and timelines. Leads meetings/teleconferences with clients as necessary. Leads research of industry practices and processes and applies to innovative drug development internally and for client products. Presents recommendations internally and to clients. Leads development of processes that meet or exceed the expectations from clients and provide innovation as necessary Guides and advises during implementation of new methodologies and processes. Leads resolution of problems related to the manufacturing of sterile pharmaceutical products. Liaises with internal scientific, analytical, and laboratory functional areas to meet project and team objectives. Provides mentoring to other scientists, facilitates review of documents, helps define project scope, and uses knowledge to interpret proposal definition versus client expectations. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.
How Will You Get There?
Bachelors of Science in Chemistry, Biochemistry, Biology, or related physical science. MS or PhD preferred but not required based on consummate related experience.
Typically requires 12 years of progressive scientific experience, including 9 years in a related life sciences field.
If related Master's degree, typically requires 10 years of related experience.
If related PhD, typically requires 6 years’ experience. Experience working directly with clients.