Associate Director/ Director of Upstream Process Development (Biologics)

Location: Boston, MA
Reports To: Director of Process Development
Salary Range: $170,000 - $220,000 (commensurate with experience)

Position Summary

The Associate Director, Upstream Biologics will lead upstream process development activities for biologics programs, including monoclonal antibodies, recombinant proteins, and other large molecules. This role will oversee a team of scientists and engineers, driving innovation and scalability from early development through clinical and commercial manufacturing. The ideal candidate has deep technical expertise in cell culture and bioreactor operations, strong leadership skills, and experience in tech transfer to GMP facilities.

Key Responsibilities

• Strategic Leadership:

  • Develop and execute upstream process development strategies aligned with program timelines and regulatory requirements.
  • Provide technical leadership for cell culture optimization, scale-up, and process characterization.

• Team Management:

  • Lead and mentor a team of scientists and engineers, fostering a culture of collaboration and scientific excellence.
  • Allocate resources effectively across multiple projects.

• Technical Execution:

  • Design and optimize mammalian cell culture processes for high-yield biologics production.
  • Oversee bioreactor operations (bench-scale to pilot-scale) and implement process analytical technologies (PAT).
  • Support process characterization and validation studies for late-stage programs.

• Cross-Functional Collaboration:

  • Partner with downstream, analytical, and quality teams to ensure seamless integration of upstream processes.
  • Drive tech transfer to internal or external GMP manufacturing sites.

• Regulatory & Documentation:

  • Author and review CMC sections for IND/BLA submissions.
  • Ensure compliance with cGMP, ICH, and other regulatory guidelines.

Qualifications

• Ph.D. or M.S. in Chemical Engineering, Biochemistry, or related field with 8+ years of industry experience in biologics process development.
• Proven track record in mammalian cell culture and bioreactor scale-up (single-use and stainless steel systems).
• Experience with DOE, QbD principles, and process characterization.
• Strong leadership and project management skills.
• Excellent communication and collaboration abilities.

Preferred Experience

• Familiarity with perfusion and fed-batch processes.
• Prior experience in tech transfer to CDMOs or internal GMP facilities.
• Knowledge of regulatory filings and late-stage development requirements.