Senior Specialist, Research Medical Device Combination Products - Onsite

Merck & Co., Inc.

Rahway, NJ, USA
Base: $106,200.00 - $167,200.00; bonus/equity: ann...
Hybrid
Gmp compliance for medical devices
Method validation and transfer activities
Clinical supply release testing
The role involves supporting GMP testing of devices and combination products including method validation and transfer activities

Job Summary

  • The role involves supporting GMP testing of devices and combination products including method validation and transfer activities.
  • Candidates will collaborate with a global team to build robust methods for clinical and commercial product release and stability testing.
  • The position offers a comprehensive benefits package including medical, dental, vision, retirement benefits, and paid holidays.

Matching Summary

The role involves supporting GMP testing of devices and combination products including method validation and transfer activities.

Salary

Base: $106,200.00 - $167,200.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • GMP compliance for medical devices
  • Method validation and transfer activities
  • Clinical supply release testing
  • ALCOA data documentation principles
  • Cross-functional team collaboration

Nice-to-have

  • Hands-on experience with ISO standards
  • FDA and MDR regulatory familiarity
  • Leading cross-functional teams
  • Statistical analysis skills
  • Engineering studies experience

Key Requirements

  • PhD degree or MS with 4 years experience
  • 7 years experience with BS in Science or Engineering
  • US residency required (no visa sponsorship)

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter