Associate Director, Gmp Quality Assurance

Apogee Therapeutics Inc.

Remote, US
Base: $165,000-$195,000; bonus/equity: performance...
Remote
8+ years gmp qa experience
Monoclonal antibody manufacturing
Cdmo oversight and partnership
This role is pivotal in ensuring the quality, safety, and compliance of biologics manufacturing processes and device development activities for a clinical-stage biotechnology company

Job Summary

  • This role is pivotal in ensuring the quality, safety, and compliance of biologics manufacturing processes and device development activities for a clinical-stage biotechnology company.
  • The successful candidate will partner with Technical Operations to oversee contract development manufacturing organizations (CDMOs) and independently perform GMP audits.
  • Apogee Therapeutics offers a competitive compensation package including base salary, performance bonus, equity grants, and three weeks of PTO.

Matching Summary

This role is pivotal in ensuring the quality, safety, and compliance of biologics manufacturing processes and device development activities for a clinical-stage biotechnology company.

Salary

Base: $165,000-$195,000; Bonus/Equity: Performance bonus and equity grant opportunities; Benefits: Health, welfare, retirement benefits, and three weeks PTO

Skills & Requirements

Must-have

  • 8+ years GMP QA experience
  • Monoclonal antibody manufacturing
  • CDMO oversight and partnership
  • FDA/EMA/ICH regulatory knowledge
  • Batch record review and release
  • Electronic QMS proficiency

Nice-to-have

  • Advanced degree in science
  • Analytical instrumentation validation
  • Stability program management
  • Risk-based quality approaches
  • Culture of continuous improvement
  • Strong communication skills

Key Requirements

  • Bachelor's degree in scientific discipline
  • Minimum 8 years GMP QA experience
  • Direct experience with monoclonal antibodies
  • Experience with CDMO oversight
  • In-depth knowledge of FDA/EMA regulations

Work Rights

Not specified

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