Senior Scientist, Regulatory Cmc Biologics

Merck & Co., Inc.

Base: $117,000.00 - $184,200.00; bonus/equity: ann...
**
5 years regulatory cmc experience
Biologics drug substance development
Ind/bla documentation management
** Merck & Co., Inc. is seeking a Senior Scientist for Regulatory CMC Biologics to lead CMC regulatory projects and ensure compliance with global regulatory strategies throughout the product lifecycle. The ideal candidate will possess a strong background in biological drug development and regulatory affairs, with a focus on delivering regulatory milestones effectively. **

Job Summary

  • The role serves as a Regulatory CMC Project Lead accountable for delivering all regulatory milestones through product development and post-approval life cycles.
  • Candidates must ensure the execution of global product regulatory strategies by assessing requirements and identifying potential risks for 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 for Regulatory CMC Biologics to lead CMC regulatory projects and ensure compliance with global regulatory strategies throughout the product lifecycle. The ideal candidate will possess a strong background in biological drug development and regulatory affairs, with a focus on delivering regulatory milestones effectively. **

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/BLA documentation management

Nice-to-have

  • Advanced degree in science or engineering
  • Global regulatory strategy execution
  • Strong interpersonal relationships

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