Principal Scientist, Drug Substance Process Development & Manufacturing

Generate Biomedicines•Somerville, MA

1d•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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