Senior Scientist, Regulatory Cmc Biologics

Merck & Co., Inc.

Rahway, NJ, USA
Base: $117,000.00 - $184,200.00; bonus/equity: ann...
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5 years regulatory cmc experience
Biologics drug substance development
Ind/impd and bla/maa documentation
** Merck & Co., Inc. is seeking a Senior Scientist in Regulatory CMC Biologics to lead regulatory strategies for biological projects in a hybrid work environment. The ideal candidate will have at least five years of relevant regulatory experience and a strong scientific background, particularly in biologics and drug product development. **

Job Summary

  • The role serves as a Regulatory CMC Project Lead accountable for delivering all regulatory milestones through product development and the post-approval life cycle.
  • Candidates must ensure the execution of global product regulatory strategies by assessing requirements and identifying potential risks for assigned biological projects.
  • The company offers a comprehensive benefits package including medical, dental, vision, 401(k), and paid holidays with a hybrid work model.

Matching Summary

Match Score: 75

** Merck & Co., Inc. is seeking a Senior Scientist in Regulatory CMC Biologics to lead regulatory strategies for biological projects in a hybrid work environment. The ideal candidate will have at least five years of relevant regulatory experience and a strong scientific background, particularly in biologics and drug product development. **

Salary

Base: $117,000.00 - $184,200.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • 5 years Regulatory CMC experience
  • Biologics drug substance development
  • IND/IMPD and BLA/MAA documentation

Nice-to-have

  • Advanced degree in science or engineering
  • Strong interpersonal relationships skills
  • Detail-oriented approach to compliance

Key Requirements

  • B.S. in science, engineering, or related field
  • 5 years of Regulatory CMC related experience
  • Experience in biologics Regulatory CMC preferred

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter