Senior Drug Substance (API) Technical Operations Manager (Marlborough)Hornet Staffing, Inc, a GEE Group company • Marlborough, MA, US
Senior Drug Substance (API) Technical Operations Manager (Marlborough)
Hornet Staffing, Inc, a GEE Group company • Marlborough, MA, US
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job_description.job_card.job_descriptionSupport / lead process change activities for small molecule drug substances, intermediates and raw materials as SME Lead investigations, functioning as SME and resolve discrepancies in a timely manner Work closely with small molecule DS manufacturing team to understand the capabilities, capacity availability and constraints at the CMOs, develop plans to secure capacity appropriately Provide technical oversight during GMP manufacturing campaigns Work closely with Quality Assurance, Regulatory Affairs, Supply Chain, and external manufacturing partners to ensure alignment on timelines and deliverables Strong technical writing and analytical problem-solving capabilities Ability to work independently with minimal guidance Exercise good judgment and make decision that is appropriate for the organization Results-driven, take initiative and ownership to accomplish work Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment Min 6-8 years experience working in small molecule DS (API) manufacturing as SME in a GMP environment Has functioned as SME for process changes and investigations Position is not for those working in diagnostics, cosmetics, biologics, QA, QC, Regulatory, PM External manufacturing / operations Drug substance contract manufacturing Chemical manufacturing Manufacturing sciences & technology (MSAT) Chemical or Process Development (but I'm less sanguine about these titles since people in these roles are more early / mid-stage, with less exposure to the business and regulatory aspects of commercial work)
Desired background and experience :
- Bachelor's degree in Science / Engineering / Operations or a related field
- At least 8+ years of experience in the small molecule DS (API)_manufacturing or development environment
- Experience with lifecycle management for commercial products
- Knowledge of Good Manufacturing Practices (GMPs)
Requirements :
Must Have's :
Job functions :
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Senior Technical Api • Marlborough, MA, US
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