Principal Scientist, Drug Substance Process Development & Manufacturing (mab Development Focus)

Generate:Biomedicines

Somerville, MA, United States
Base: $160,000 – $224,000 usd py; bonus/equity: el...
On-site
Monoclonal antibody drug substance development
Gmp documentation and quality systems
Cdmo management and tech transfer
This role supports monoclonal antibody drug substance development with a strong focus on bridging process development, scale-up, and GMP manufacturing execution

Job Summary

  • This role supports monoclonal antibody drug substance development with a strong focus on bridging process development, scale-up, and GMP manufacturing execution.
  • The ideal candidate will leverage AI-driven tools to enable efficient CMC workflows while ensuring robust documentation and data integrity.
  • Join a clinical-stage generative biology company pioneering the AI revolution in drug design to deliver innovative biologics faster.

Matching Summary

This role supports monoclonal antibody drug substance development with a strong focus on bridging process development, scale-up, and GMP manufacturing execution.

Salary

Base: $160,000 – $224,000 USD per year; Bonus/Equity: Eligible for annual bonus and equity compensation; Benefits: Competitive benefits package included

Skills & Requirements

Must-have

  • Monoclonal antibody drug substance development
  • GMP documentation and quality systems
  • CDMO management and tech transfer
  • Upstream and downstream process operations
  • Process characterization and PPQ studies

Nice-to-have

  • Experience supporting BLA/IND submissions
  • AI-driven tools for knowledge management
  • Accelerated development environment exposure
  • Cross-functional program leadership
  • Continuous process improvement initiatives

Key Requirements

  • PhD or MS in Chemical Engineering, Biochemistry, or related field
  • 5–8 years of industry experience in Drug Substance process development
  • Hands-on experience with GMP batch records and quality systems
  • Demonstrated ability to lead complex technical programs

Work Rights

Not specified

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