Principal Scientist, Drug Substance Process Development & Manufacturing; mAB development focus

The Role

We are seeking a Principal Scientist, DS Process Development & Manufacturing, to join our growing Drug Substance group at Generate:

Biomedicines
. This role will support monoclonal antibody (mAb) drug substance development with a strong MS&T focus, bridging process development, scale-up, tech transfer, and GMP manufacturing execution. The position offers broad exposure across upstream and downstream operations, CDMO management, and quality systems.

• Support Drug Substance process development and manufacturing activities (e.g., upstream expression, purification, UF/DF, viral clearance)
• Design and execute scale-up, process characterization, and PPQ-enabling studies
• Own tech transfer and support GMP campaigns at CDMO (person-in-plant support as needed)
• Review and/or author GMP documentation including batch records, change controls, deviations and CAPAs
• Provide technical leadership for GMP manufacturing, including troubleshooting and data‑driven decision making
• Partner cross‑functionally across CMC, QA, Regulatory, and Supply Chain to drive program execution
• Drive continuous process improvement and process robustness initiatives
• Leverage AI‑driven tools for knowledge management and data analysis to enable efficient and scalable CMC workflows

• PhD or MS in Chemical Engineering, Biochemistry, or related field with relevant industry experience in biologics manufacturing
• 5–8 years of industry experience in Drug Substance process development and/or GMP manufacturing in a biotech/pharma setting
• Strong attention to detail with the ability to analyze complex technical data
• Excellent communication and strong technical writing skills
• Experience working with CDMOs, supporting tech transfer, and regulatory submissions
• Hands‑on experience with GMP documentation (eg: executed Batch Records) and quality systems (deviations, change control, CAPA)
• Demonstrated ability to lead complex technical programs and collaborate effectively in cross‑functional teams.
• Familiarity of regulatory issues pertaining to the manufacture of biologics, process validation, QbD principles and industry trends

• Experience supporting BLA/IND submissions.
• Exposure to accelerated development environments for early to late‑stage program transitions

This role is based out of Somerville, MA with flexibility for hybrid work (1-2 days a week in the office).

This is an opportunity to contribute to the development of innovative biologics at a company transforming medicine through Generative Biology™. At Generate Biomedicines
, you’ll work closely with cross‑functional teams and external partners to support the delivery of high‑quality Drug Substance for clinical programs. You’ll gain or broaden your exposure to late‑stage CMC activities, collaborate with leading CDMOs, and play a key role in ensuring robust documentation and data integrity for products that matter to patients.

Per Year Salary Range: $160,000 — $224,000 USD
. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.

Generate:

Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.