Associate Director - Stability Operations

Merck Sharp & Dohme Corp

Rahway, NJ, USA
Base: $129,000.00 - $203,100.00; bonus/equity: ann...
Hybrid (3 days onsite, 1 day remote)
Gmp compliance knowledge
Stability study management
Biologics and vaccines expertise
Merck Sharp & Dohme Corp is seeking an Associate Director for Stability Operations to oversee GMP stability studies for large molecule portfolios at their Rahway, NJ facility. The ideal candidate should possess significant experience in regulatory compliance, stability study management, and effective cross-functional collaboration

Job Summary

  • The role involves overseeing and managing end-to-end GMP stability studies and logistics for a large molecule portfolio across the global network.
  • Candidates must possess strong cross-functional collaboration skills to work effectively within a fast-paced, integrated multidisciplinary team environment.
  • The position offers a competitive salary range of $129,000.00 to $203,100.00 along with comprehensive benefits including medical, dental, vision, and retirement plans.

Matching Summary

Match Score: 85

Merck Sharp & Dohme Corp is seeking an Associate Director for Stability Operations to oversee GMP stability studies for large molecule portfolios at their Rahway, NJ facility. The ideal candidate should possess significant experience in regulatory compliance, stability study management, and effective cross-functional collaboration.

Salary

Base: $129,000.00 - $203,100.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays

Skills & Requirements

Must-have

  • GMP compliance knowledge
  • Stability study management
  • Biologics and vaccines expertise
  • Cross-functional collaboration
  • LIMS and data management systems

Nice-to-have

  • Statistical analysis of stability data
  • Predictive shelf-life modeling
  • Facility gap analysis experience
  • Change management champion
  • Regulatory submission authoring

Key Requirements

  • Ph.D. with 2 years experience or Master's with 6 years or Bachelor's with 10+ years
  • Knowledge of regulatory guidance for stability testing
  • Experience with analytical methods like HPLC and ELISA
  • VISA Sponsorship available

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter