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Manager, Product Transfer
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Full-time
- Job Title: Manager, Product TransferLocation: Cherry Hill, NJ Job Type: Full time Req ID: 6132 About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health.
- Key Responsibilities: Lead the team enabling the transfer of products of varying types from R&D, another Hikma facility or CMO to Commercial Operations as a Process Champion from Hikma Lead the team enabling technical evaluation of site capabilities, process development, registration lots manufacturing, and FDA filings.
- SKILLS Expert implementation knowledge of applicable guidance and regulations regarding development and manufacturing of injectable pharmaceuticals, including FDA, cGMP, DEA, OSHA and other applicable regulatory and company guidelines.
- Expert knowledge of injectable pharmaceutical formulation development, processing equipment, quality by design, and cGMP production with emphasis on scale-up/ optimization and validation.
- B.S. degree in Engineering, Chemistry, or related scientific discipline plus a minimum of fifteen (15) years of experience in pharmaceutical product transfer, process development, technology transfer and validation, and/or process engineering for injectable products in a GMP environment.
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