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Sr. Manager, Technical Development, Raw Materials
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- an experienced Bioprocess scientist or engineer with a strong process development background in the regulated biopharmaceutical environment
- The successful candidate must be able to work in a fast paced and highly dynamic environment, will have significant experience in biologics process development using standard bioprocess unit operations (e.g. reactions, mixing, chromatography, tangential flow and/or normal filtration
- BS with a minimum of 8 years of experience, MS with a minimum of 5 years experience, or PhD with post-doctoral or industry experience in bioprocess development and/or manufacturing sciences.
- Accomplished background in process development (late-phase preferred) and process technology transfer for large biomolecules using QbD principles (sender or receiver)
- Knowledge of the large molecule regulatory environment, particularly FDA/ICH/ISPE guidelines on risk management, technology transfer and process validation
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