Associate Director, Technical Operations - Small Molecule Drug Product
Merck · Elkton, VA
CMCFull-time$142k–$224kCompany career page
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Role summary
Associate Director leading technical operations for small molecule oral solid dosage manufacturing at a U.S. facility. Responsible for process oversight, technology transfer, validation, and commercial manufacturing excellence from startup through lifecycle management.
What they're looking for
- Bachelor's degree or higher in Chemical Engineering, Pharmaceutics, or related discipline
- 10+ years experience in oral solid dose manufacturing or process development
- Strong expertise in process engineering, scale-up, and validation activities
- Knowledge of cGMP operations, regulatory expectations, and inspection readiness
- Experience with deviation management, investigations, and batch record systems
- Demonstrated problem-solving and cross-functional team collaboration skills
What you'll be doing
- Provide technical oversight and leadership for blending, granulation, compression, coating, and finishing operations
- Lead technology transfer activities, scale-up, and validation from development to commercial scale
- Partner with manufacturing to troubleshoot processes, investigate deviations, and drive continuous improvement
- Ensure compliance with cGMP and regulatory standards; support audits and submissions
- Lead and develop team of technical specialists and engineers
Privacy & handoff
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