Senior Drug Substance (API) Technical Operations Manager
$99.5k - $156.42kHornet Staffing, Inc, a GEE Group company
Senior Drug Substance (API) Technical Operations Manager Location: Lexington, MA | Salary: $99,500.00 - $156,420.00 | 3 weeks ago. Education & 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 Support / 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 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 decisions that are 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 Must Haves 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 Job Functions External manufacturing/operations Drug substance contract manufacturing Chemical manufacturing Manufacturing sciences & technology (MSAT) Chemical or Process Development (though less emphasis on early/mid-stage titles) Seniority Level Mid‑Senior level Employment Type Contract Job Function Project Management and Product Management Industries Pharmaceutical Manufacturing #J-18808-Ljbffr Hornet Staffing, Inc, a GEE Group company
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