The successful candidate will join the Manufacturing Sciences (MS) department to provide laboratory based technical support to clinical and commercial biologics cell culture processes.
• Primarily responsible for hands on execution and documentation of upstream cell culture experiments in the Laboratory and/or pilot plant.
• Develop, transfer and maintain qualified scale-down models (spinner flasks, shake flasks and bench top bioreactors) for the evaluation of medium and processes. Coordination of studies with the GMP manufacturing organization performing cell culture at large-scale may be necessary.
• Design, execute and document laboratory experiments using scale down models to 1) perform trouble-shooting and support effective root cause investigations and CAPA recommendations for manufacturing deviations; 2) evaluate raw materials; 3) support process validation; 4) expand process knowledge, identify and implement lifecycle process improvements for commercial manufacturing processes.
• Develop sampling protocols and coordinate manufacturing sample collection and submission related to process validation, troubleshooting and process improvement studies.
• Activities surrounding novel program technical improvements will also be required.
• Contribute to manufacturing data management and statistical analysis of data aimed at process knowledge development/ownership and resolution of investigations.
• Coordination and interfacing with Technical Development, Manufacturing, QA/QC teams and MS team members.
Biopharmaceutical Sciences (MFG)
BS or MS degree in Biochemistry, Chemical Engineering, Chemistry, Biology or a related scientific discipline. Knowledge and direct experience of cell culture techniques, mammalian preferred, including, cell biology, biochemistry, analytical techniques, and bioreactor operations. Understanding of statistical applications, such as DOE and JMP. Demonstrated technical proficiency and creativity is desired. This role requires excellent written and oral communication skills. The candidate must be able to work both independently and as part of an interdisciplinary team.
BS + 4 years relevant experience or MS + 2 years relevant experience
Biogen (NASDAQ: BIIB) is a global leader in the discovery, development and delivery of innovative therapies to improve the lives of...