Director, Gmp Quality Assurance

Apogee Therapeutics

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 partnership
Apogee Therapeutics is seeking a Director of GMP Quality Assurance to ensure compliance and quality in the manufacturing of biologics. The ideal candidate should have extensive experience in GMP quality assurance within the biopharmaceutical sector, particularly with monoclonal antibodies, and will be instrumental in supporting the company's mission to deliver innovative therapies

Job Summary

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

Matching Summary

Match Score: 85

Apogee Therapeutics is seeking a Director of GMP Quality Assurance to ensure compliance and quality in the manufacturing of biologics. The ideal candidate should have extensive experience in GMP quality assurance within the biopharmaceutical sector, particularly with monoclonal antibodies, and will be instrumental in supporting the company's mission to deliver innovative therapies.

Salary

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

Skills & Requirements

Must-have

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

Nice-to-have

  • Advanced degree in scientific discipline
  • Quality Management System Regulations experience
  • Analytical instrumentation validation expertise
  • Risk-based quality management approach
  • Culture of continuous improvement mindset

Key Requirements

  • Bachelor's degree in relevant scientific discipline required
  • Minimum 10 years experience in GMP QA within biotech/pharma
  • Direct experience auditing and manufacturing monoclonal antibodies
  • In-depth knowledge of FDA, EMA, and ICH regulations
  • Up to 20% travel including mandatory in-person attendance

Work Rights

Not specified

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