Senior Drug Substance (API) Technical Operations Manager

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:

• 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
• 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

Must Have's:

• 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

Job functions:

• 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)