Director, Biologics Development and Commercialization Team Lead (CMC Team Lead)
Merck
July 02, 2026
Remote friendly (West Point, PA)
United States
Operations
Responsibilities:
- Deliver an integrated, stage-appropriate CMC development and commercialization strategy to yield the target commercial product; advance the biologics portfolio.
- Ensure on-time, end-to-end execution of CMC deliverables (processes & analytics, integrated control strategy, tech transfer packages, filings/approvals, robust commercial supply chain).
- Lead the DCT team; critically assess deliverables; foster a learning/collaborative environment; prioritize, interrogate, and mitigate technical, operational, and regulatory risks.
- Partner with DCRC; ensure best science and robust processes; provide options analysis and recommendations to governance.
- Represent CMC across governance and stakeholders; influence/advocate/negotiation to drive decisions; balance Speed/Cost/Robustness; direct technical reviews.
- Execute GMP and comply with global and regulatory requirements.
- Work collaboratively to drive a safe and compliant culture.
Qualifications / Education & Experience:
- BS in relevant engineering/science + 15 years; or MS + 12 years; or PhD + 10 years relevant experience.
Required Skills / Experience:
- Cross-divisional networking; functional and enterprise leadership; influence at all levels.
- Collaborative, strategic, detail-oriented; ability to work with management.
- Strong understanding of product management systems/tools; business and financial skills; manage multiple programs; build high-performance environment.
Preferred:
- Technical product stewardship.
- Track record commercializing multiple large molecule programs.
- Expert knowledge of global regulatory requirements for large molecule commercialization and BLA assembly.
Required/Preferred Skills (from posting):
- Capital/change management; chemical process development; external manufacturing; GMP compliance; innovation; manufacturing scale-up; process improvements; sterile filling; decision making; strategic thinking; writing technical documents.
Application instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if current employee). Application deadline is stated on the posting.
- Deliver an integrated, stage-appropriate CMC development and commercialization strategy to yield the target commercial product; advance the biologics portfolio.
- Ensure on-time, end-to-end execution of CMC deliverables (processes & analytics, integrated control strategy, tech transfer packages, filings/approvals, robust commercial supply chain).
- Lead the DCT team; critically assess deliverables; foster a learning/collaborative environment; prioritize, interrogate, and mitigate technical, operational, and regulatory risks.
- Partner with DCRC; ensure best science and robust processes; provide options analysis and recommendations to governance.
- Represent CMC across governance and stakeholders; influence/advocate/negotiation to drive decisions; balance Speed/Cost/Robustness; direct technical reviews.
- Execute GMP and comply with global and regulatory requirements.
- Work collaboratively to drive a safe and compliant culture.
Qualifications / Education & Experience:
- BS in relevant engineering/science + 15 years; or MS + 12 years; or PhD + 10 years relevant experience.
Required Skills / Experience:
- Cross-divisional networking; functional and enterprise leadership; influence at all levels.
- Collaborative, strategic, detail-oriented; ability to work with management.
- Strong understanding of product management systems/tools; business and financial skills; manage multiple programs; build high-performance environment.
Preferred:
- Technical product stewardship.
- Track record commercializing multiple large molecule programs.
- Expert knowledge of global regulatory requirements for large molecule commercialization and BLA assembly.
Required/Preferred Skills (from posting):
- Capital/change management; chemical process development; external manufacturing; GMP compliance; innovation; manufacturing scale-up; process improvements; sterile filling; decision making; strategic thinking; writing technical documents.
Application instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if current employee). Application deadline is stated on the posting.