Senior Scientist, Regulatory Cmc Biologics

29

Base: $117,000.00 - $184,200.00; bonus/equity: ann...
Hybrid (three days on-site, monday - thursday; remote on fridays)
5 years regulatory cmc experience
Biologics drug substance development
Ind/impd and bla/maa documentation
The company is seeking a Senior Scientist for Regulatory CMC Biologics, responsible for leading CMC regulatory strategies and ensuring compliance throughout the product development and approval processes. The ideal candidate should have at least five years of experience in regulatory CMC and a relevant scientific background

Job Summary

  • Serve as a Regulatory CMC Project Lead providing leadership within cross-functional teams for assigned biological projects.
  • 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).
  • Employees in office-based positions in the U.S. will work a Hybrid model consisting of three days on-site per week with Friday designated as remote.

Matching Summary

Match Score: 85

The company is seeking a Senior Scientist for Regulatory CMC Biologics, responsible for leading CMC regulatory strategies and ensuring compliance throughout the product development and approval processes. The ideal candidate should have at least five years of experience in regulatory CMC and a relevant scientific background.

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 relationship skills
  • Detail-oriented regulatory compliance focus

Key Requirements

  • B.S. in science, engineering, or related field
  • 5 years of Regulatory CMC related experience
  • No visa sponsorship available

Work Rights

Not specified

Tailored Resume

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