Associate Director, External Development and Manufacturing, Drug Product
MSD
Summary
Our company's Pharmaceutical Sciences and Device Development organization translates molecules into medicines from discovery through registration by designing, developing, scaling, and transferring formulations, devices, and manufacturing processes. The External Development and Manufacturing team executes the drug product and device sourcing strategy across small- and large-molecule research and development.
Job description
The Associate Director independently leads formulation, device, process development, and current Good Manufacturing Practice drug product manufacturing activities at external providers. Working within matrix teams that include product development, Quality, Analytical, Procurement, and Global Clinical Supply, the role supports oral solid dosage forms, biologics, vaccines, specialty products, and drug-device combinations. The position also contributes to operational excellence, external network strategy, and productive vendor relationships.
Key Responsibilities
- Plan and coordinate formulation, device, process development, and clinical manufacturing activities at contract research and manufacturing organizations.
- Provide manufacturing, compliance, and execution expertise to project teams; manage timelines, deliverables, risks, and issue resolution.
- Develop project requests for proposals; evaluate responses and recommend vendors based on technical fit, unit operations, safety classification, capacity, timing, geography, and clinical supply needs.
- Identify, establish, and maintain trusted vendor relationships aligned with pipeline needs across oral formulation, sterile and specialty products, device development, and discovery pharmaceutical sciences.
- Support technology evaluations through external partner discussions, confidentiality agreements, technical information exchange, and guidance on appropriate scope and agreement structure.
- Collaborate across scientific and operational functions to optimize externalization activities, improve workflows, and advance portfolio-level operational excellence.
- Provide business and logistical support for non-manufacturing activities, including device development, device evaluation, and process development.
- 10% Travel
Education Minimum Requirement
B.S. with at least 8 years of relevant industrial experience, or M.S. with at least 6 years, or Ph.D. with at least 4 years in Chemical Engineering, Pharmaceutical Sciences, or a related engineering or scientific discipline.
Required Experience and Skills
- Relevant pharmaceutical development, clinical manufacturing, supply chain, or external manufacturing experience.
- Demonstrated vendor and project management, cross-functional collaboration, and independent execution of business deliverables.
- Strong knowledge of GMP, regulatory expectations, manufacturing compliance, and drug product development.
- Excellent communication, facilitation, and stakeholder engagement skills with the ability to influence teams without direct authority.
- Strategic thinking, business acumen, creativity, sound judgment, and the ability to navigate ambiguity and solve complex problems with rigor.
Preferred Experience and Skills
- Direct drug product manufacturing, specialized scientific, or device development experience.
- Experience leading business process optimization, continuous improvement, or transformation initiatives.
- Familiarity with SAP for material build and transactions.
Requirements
- B.S. with at least 8 years of relevant industrial experience, or M.S. with at least 6 years, or Ph.D. with at least 4 years in Chemical Engineering, Pharmaceutical Sciences, or a related engineering or scientific discipline
- Relevant pharmaceutical development, clinical manufacturing, supply chain, or external manufacturing experience
- Demonstrated vendor and project management, cross-functional collaboration, and independent execution of business deliverables
- Strong knowledge of GMP, regulatory expectations, manufacturing compliance, and drug product development
- Excellent communication, facilitation, and stakeholder engagement skills with the ability to influence teams without direct authority
- Strategic thinking, business acumen, creativity, sound judgment, and the ability to navigate ambiguity and solve complex problems with rigor
- Preferred: Direct drug product manufacturing, specialized scientific, or device development experience
- Preferred: Experience leading business process optimization, continuous improvement, or transformation initiatives
- Preferred: Familiarity with SAP for material build and transactions
Benefits
- Medical, Dental & Vision
- Retirement Benefits
- 401(k)
- Paid Holidays
- Vacation
- Compassionate Leave
- Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
MSD, known as Merck Sharp & Dohme outside the United States and Canada, is a global research-intensive biopharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891, the company has established itself as one of the world's leading pharmaceutical corporations with a rich history spanning over 130 years. MSD operates as the international division of Merck & Co., Inc., focusing on the discovery, development, manufacturing, and marketing of innovative medicines, vaccines, biologic therapies, and animal health products. The company's extensive portfolio includes groundbreaking treatments in oncology, infectious diseases, cardiology, diabetes, and vaccines, with notable products such as Keytruda (pembrolizumab) for cancer immunotherapy, Gardasil for HPV prevention, and Januvia for diabetes management. MSD maintains a strong commitment to research and development, investing significantly in scientific innovation to address unmet medical needs worldwide. With approximately 75,000 employees globally, the company operates through four main segments: pharmaceuticals, animal health, healthcare services, and strategic alliances. MSD's mission centers on using leading-edge science to save and improve lives around the world, guided by the principle that medicine is for people, not profits.