Associate Director, External Development and Manufacturing, Drug Product
$129k - $203.1kMerck
Associate Director role leading formulation, device, and manufacturing process development activities at external contract organizations. Manages vendor relationships, project execution, and clinical supply coordination across diverse product modalities including oral solids, biologics, and vaccines.
Responsibilities
- Plan and coordinate formulation, device, process development, and clinical manufacturing activities at contract research organizations
- Provide manufacturing expertise and manage timelines, deliverables, risks, and issue resolution for project teams
- Develop and evaluate vendor requests for proposals; recommend providers based on technical fit, capacity, and clinical supply needs
- Establish and maintain trusted vendor relationships aligned with pipeline needs across formulation, sterile, specialty, and device development
- Collaborate across functions to optimize externalization activities and advance portfolio-level operational excellence
Requirements
- Bachelor's degree with 8+ years relevant industrial experience, or Master's with 6+ years, or PhD with 4+ years in Chemical Engineering, Pharmaceutical Sciences, or related discipline
- Pharmaceutical development, clinical manufacturing, supply chain, or external manufacturing experience
- Demonstrated vendor and project management with cross-functional collaboration capability
- Strong GMP knowledge, regulatory expectations, manufacturing compliance, and drug product development expertise
- Excellent communication, facilitation, and stakeholder engagement skills; ability to influence without direct authority
- Strategic thinking, business acumen, and ability to solve complex problems with rigor
Compensation: $129,000–$203,100 base
$174.13k - $199.62k
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