Senior Drug Substance (API) Technical Operations Manager

Hornet Staffing, Inc, a GEE Group company; Marlborough (MA); On-site; USD 99,500 - 156,420; Part time

Job summary

A staffing agency is seeking a Senior Drug Substance (API) Technical Operations Manager to oversee small molecule drug substance operations. The ideal candidate will have over 8 years of experience in manufacturing within a GMP environment and be adept at managing process changes. This mid-senior level position requires strong analytical skills and technical writing capabilities. This role will involve collaboration with various teams and requiring effective problem-solving in a dynamic pharmaceutical manufacturing environment.

Qualifications

• Bachelor's degree in Science, Engineering, or Operations required.
• 8+ years of experience in small molecule DS (API) manufacturing necessary.
• Expertise in GMP established.

Responsibilities

• Lead process change activities for small molecule drug substances.
• Conduct investigations and resolve discrepancies.
• Collaborate with manufacturing team to understand capabilities and constraints.

Skills

Process change management

Analytical problem-solving

Technical writing

Independence

Education

Bachelor's degree in Science/Engineering/Operations

Job description

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