Director, Drug Product Process Development – Biologics

Vertex Pharmaceuticals

Boston, MA, United States
Base: $200,000 - $300,000; bonus/equity: eligible ...
On-site
Biologics drug product development
Formulation and fill-finish process development
Technology transfer to cdmos
Lead the development and manufacturing of biologics drug products for a growing pipeline, encompassing formulation, primary container, and fill-finish processes

Job Summary

  • Lead the development and manufacturing of biologics drug products for a growing pipeline, encompassing formulation, primary container, and fill-finish processes.
  • Drive technical and strategic decision-making by collaborating closely with drug substance, analytical, device development, and supply chain teams within CMC.
  • Identify and implement innovative technologies and best practices to enhance process robustness, efficiency, and compliance, with potential to build and manage a team.

Matching Summary

Lead the development and manufacturing of biologics drug products for a growing pipeline, encompassing formulation, primary container, and fill-finish processes.

Salary

Base: $200,000 - $300,000; Bonus/Equity: Eligible for annual bonus and equity awards; Benefits: Market-leading benefits package

Skills & Requirements

Must-have

  • Biologics drug product development
  • Formulation and fill-finish process development
  • Technology transfer to CDMOs
  • Process validation for clinical pipeline
  • Combination product development

Nice-to-have

  • Innovative technology implementation
  • Cross-functional collaboration
  • Subject matter expert in regulatory interactions

Key Requirements

  • PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or related discipline
  • Minimum of 11 years of experience in drug product development and manufacturing
  • Expertise in formulation development of recombinant proteins
  • Experience with process characterization and QbD principles
  • Extensive knowledge of cGMPs and regulatory guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter