Director, Gmp Quality Assurance

Apogee Therapeutics IncA

Remote, US
Base: $210,000-$235,000; bonus/equity: performance...
Remote
10 years gmp quality assurance experience
Monoclonal antibody or biologics manufacturing
Cdmo oversight and auditing
Apogee Therapeutics is seeking a Director of GMP Quality Assurance to oversee quality, safety, and compliance for its biologics manufacturing processes. The ideal candidate will have extensive experience in GMP quality assurance, particularly in the biotech or pharmaceutical industry, and a commitment to fostering a collaborative culture. This remote position offers competitive compensation and a dynamic work environment

Job Summary

  • The role involves ensuring the quality, safety, and compliance of biologics manufacturing processes and device development activities.
  • Candidates will partner with Technical Operations to oversee contract development manufacturing organizations for Phase 3 and process performance qualification activities.
  • The company offers a competitive compensation package including base salary, performance bonus, equity grants, and three weeks of PTO.

Matching Summary

Match Score: 85

Apogee Therapeutics is seeking a Director of GMP Quality Assurance to oversee quality, safety, and compliance for its biologics manufacturing processes. The ideal candidate will have extensive experience in GMP quality assurance, particularly in the biotech or pharmaceutical industry, and a commitment to fostering a collaborative culture. This remote position offers competitive compensation and a dynamic work environment.

Salary

Base: $210,000-$235,000; Bonus/Equity: Performance bonus and equity grant opportunities; Benefits: Health, welfare, retirement benefits, three weeks PTO

Skills & Requirements

Must-have

  • 10 years GMP quality assurance experience
  • Monoclonal antibody or biologics manufacturing
  • CDMO oversight and auditing
  • FDA EMA ICH regulatory knowledge
  • Electronic QMS implementation

Nice-to-have

  • Advanced degree in scientific discipline
  • Quality Management System Regulations experience
  • Analytical instrumentation validation expertise
  • Stability program management skills
  • Culture of continuous improvement mindset

Key Requirements

  • Bachelor's degree in relevant scientific discipline
  • Minimum 10 years of GMP QA experience
  • Direct experience with monoclonal antibodies
  • Experience with CDMO oversight
  • In-depth knowledge of FDA EMA ICH requirements

Work Rights

Not specified

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