Dir, Engineering, Cmc Leader For Biologics

Merck Sharp & Dohme Corp

Multiple Locations, US
Base: $169,700.00 - $267,200.00; bonus/equity: ann...
**
15 years relevant experience in cmc
Bachelor of science degree required
Deep understanding of biologics commercialization
** Merck Sharp & Dohme Corp is seeking a Director of Engineering, CMC Leader for Biologics, responsible for leading the Development and Commercialization Team in executing CMC strategies for their biologics portfolio. The ideal candidate should possess strong leadership, technical expertise, and collaborative skills, with significant experience in drug development and commercialization. **

Job Summary

  • The leader is accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy that yields the target commercial product.
  • This role requires leading the team to ensure on-time, end-to-end execution of deliverables including robust processes, tech transfer packages, and uninterrupted long-term supply.
  • The successful candidate will be eligible for an annual bonus, long-term incentives, and a comprehensive benefits package including medical, dental, vision, and 401(k).

Matching Summary

Match Score: 75

** Merck Sharp & Dohme Corp is seeking a Director of Engineering, CMC Leader for Biologics, responsible for leading the Development and Commercialization Team in executing CMC strategies for their biologics portfolio. The ideal candidate should possess strong leadership, technical expertise, and collaborative skills, with significant experience in drug development and commercialization. **

Salary

Base: $169,700.00 - $267,200.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • 15 years relevant experience in CMC
  • Bachelor of Science degree required
  • Deep understanding of biologics commercialization
  • Expertise in cGMP compliance and regulatory requirements
  • Strong cross-functional leadership capabilities

Nice-to-have

  • Experience in ADC development and commercialization
  • Track record of large molecule program launches
  • Expert knowledge in QbD (Quality by Design)
  • Ability to navigate ambiguity and drive innovation
  • Strong stakeholder negotiation skills

Key Requirements

  • BS Degree + 15 years experience OR MS + 12 years OR PhD + 10 years
  • Demonstrated expertise across DS, DP, Device, Packaging, Analytical, Regulatory, Quality, and Supply Chain
  • No VISA Sponsorship available
  • Strong business and financial skills required
  • Must have strong cross-divisional networking skills

Work Rights

Not specified

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