Director, Drug Product Development

Apogeetherapeutics

Remote
$210,000 to $235,000 year py
Fully remote
Prefilled syringe (pfs) manufacturing
Combination product development
Aseptic manufacturing
Apogee Therapeutics is seeking a Director of Drug Product Development to lead the development and manufacturing of protein drug products, particularly focusing on prefilled syringes. The ideal candidate will have extensive experience in drug product development, GMP operations, and collaboration across cross-functional teams, all within a fast-paced biotechnology environment

Job Summary

  • Develop protein drug product presentations and processes, oversee tech transfer to and manufacturing at CDMOs, and deliver robust drug product supply for clinical trials and launch/commercialization.
  • Serve as a subject matter expert in PFS process development and manufacturing, providing technical guidance and strategic insights to cross-functional teams.
  • Collaborate with drug product development and device teams to develop drug product presentations in vial, PFS, autoinjector, and advanced delivery technologies.

Matching Summary

Match Score: 85

Apogee Therapeutics is seeking a Director of Drug Product Development to lead the development and manufacturing of protein drug products, particularly focusing on prefilled syringes. The ideal candidate will have extensive experience in drug product development, GMP operations, and collaboration across cross-functional teams, all within a fast-paced biotechnology environment.

Salary

$210,000 to $235,000 year

Skills & Requirements

Must-have

  • prefilled syringe (PFS) manufacturing
  • combination product development
  • aseptic manufacturing
  • CDMO management
  • process development
  • GMP operations

Nice-to-have

  • QbD approach
  • advanced delivery technologies
  • process improvement
  • formulation development

Key Requirements

  • 10+ years industry experience
  • 5+ years GMP operations for PFS drug products
  • PhD or commensurate experience
  • Experience managing drug product CDMOs
  • Experience with PPQ and commercialization

Work Rights

Not specified

Tailored Resume

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