Associate Director, Technical Operations - Small Molecule Drug Substance
$142.4k - $224.1kMerck
Associate Director role overseeing technical operations for small molecule active pharmaceutical ingredient manufacturing at a U.S. facility. The position involves leading process scale-up, technology transfer, validation activities, and commercial manufacture while ensuring compliance, safety, and continuous improvement.
Responsibilities
- Provide technical oversight and hands-on leadership for API manufacturing processes including synthesis, purification, and crystallization
- Lead technology transfer activities, process scale-up, and validation across internal sites and external partners
- Partner with manufacturing teams on campaign execution, troubleshooting, and deviation investigations with root cause analysis
- Drive continuous improvement initiatives focused on yield, cycle time, and cost optimization
- Lead and develop technical specialist team, providing coaching and performance feedback
Requirements
- Bachelor's degree or higher in Chemistry, Chemical Engineering, or related discipline
- 10+ years in API process development and/or manufacturing
- Strong background in process chemistry, scale-up, and validation activities
- Working knowledge of cGMP manufacturing and regulatory inspection readiness
- Experience with deviation management, investigations, and electronic batch records
- Demonstrated cross-functional collaboration and problem-solving capabilities
Vacancy posted 22 days ago
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