Director, Operations - Drug Product (Biologics)
Merck · Wilmington (biotech), DE
CMCFull-time$173k–$273kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Director-level operations leadership role overseeing drug product manufacturing for a new high-potency biologics facility. Lead cross-functional teams through facility start-up, technology transfer, and commercial production while ensuring GMP compliance and operational excellence.
What they're looking for
- Bachelor's degree in engineering/science plus 12 years industry experience (or Master's plus 10 years, or PhD plus 8 years)
- 6+ years demonstrated leadership managing and mentoring cross-functional teams
- Experience in biotech/pharma manufacturing with sterile drug product focus
- Clinical and commercial manufacturing product experience
- Knowledge of cGMP requirements for high-potency ADC drug product manufacturing
- Lean manufacturing and process optimization expertise
- Data analysis, regulatory compliance, and quality management systems proficiency
What you'll be doing
- Lead drug product operations for commercial and new product manufacturing at the Wilmington facility
- Oversee facility start-up and production of high-potency products including antibody drug conjugates
- Manage cross-functional teams through technology transfers and commercial approvals
- Drive operational and technical excellence, implement Lean principles, and maintain inspection readiness
- Monitor departmental KPIs including hiring, uptime, training, yield, and production cadence
Privacy & handoff
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