Tech Ops Mgr./Sr. Mgr.

20-40 work hours/week

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)

Education:
Min 6-8 years experience working in small molecule DS (API) manufacturing as SME in a GMP environment

Pay ranges between $58-65/hr based on experience