Director, Biologics Development and Commercialization Team Lead (CMC Team Lead)

Location: Hybrid; primary location: West Point, Pennsylvania, USA. Additional locations: Rahway, New Jersey, USA, and Ireland. US and Puerto Rico residents only.

Salary: $173,200–$272,600 per year for the primary location, plus eligibility for annual bonus and long-term incentive where applicable.

Company

MSD is a pharmaceutical company developing and commercializing medicines, including biologics, through cross-functional scientific, regulatory, quality, and supply chain organizations.

What you will do

• Lead Development and Commercialization Teams for the biologics portfolio and deliver integrated, stage-appropriate CMC strategies through commercial product launch.
• Direct end-to-end execution across process and analytical development, control strategy, technology transfer, regulatory filing and approval, and commercial supply continuity.
• Assess deliverables, prioritize and mitigate technical, operational, regulatory, and timeline risks, and develop solutions to unforeseen challenges.
• Own product technical processes and challenges, conduct options analyses, and provide recommendations to governance bodies.
• Represent CMC across governance bodies and stakeholder groups, influencing decisions and balancing speed, cost, and robustness.
• Ensure compliance with global regulatory requirements and current Good Manufacturing Practices while fostering a safe, collaborative, and compliant culture.

Requirements

• Bachelor of Science in a relevant engineering or science field with 15 years of relevant experience, or Master of Science with 12 years, or PhD with 10 years.
• Strong understanding of technical interdependencies across drug substance, drug product, devices, packaging, analytical, regulatory, quality, and supply chain functions from early development through commercial manufacturing.
• Recognized technical leadership and scientific excellence in at least one CMC function, with the ability to navigate uncertainty and make risk-based decisions.
• Strong cross-divisional networking, functional and enterprise leadership, and influence at all organizational levels.
• Strong collaborative, strategic, detail-oriented, communication, problem-solving, decision-making, and accountability skills.
• Ability to manage multiple programs, lead complex discussions, foster high-performing teams, and create a high-performance work environment.
• Strong understanding of product management systems and tools, with strong business and financial skills.
• Ability to execute technical and operational deliverables on time while balancing speed, cost, robustness, and patient needs.

Nice to have

• Experience in technical product stewardship.
• Track record of commercializing multiple large-molecule programs across varied platforms.
• Expert knowledge of global regulatory requirements for large-molecule commercialization and BLA assembly.

Culture & Benefits

• Hybrid work arrangement with approximately 10% travel.
• Regular employee status with medical, dental, vision, insurance, retirement, 401(k), paid holidays, vacation, compassionate leave, and sick days.
• Inclusive and collaborative environment that encourages diverse perspectives, respectful challenge, collective problem-solving, and accountability.
• Visa sponsorship is not available.

Hiring process

• Current employees and contingent workers must apply through the designated internal application routes.
• Accommodation support is available for US and Puerto Rico residents who need assistance during the hiring process.