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. **Here's how you will contribute:** - 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 **The Ideal Candidate will have:** - 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 Have (Optional)** - Experience supporting BLA/IND submissions. - Exposure to accelerated development environments for early to late-stage program transitions **Location:** This role is based out of Somerville, MA with flexibility for hybrid work (1-2 days a week in the office). **Why Join Us?** 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. **About Generate Biomedicines** We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines. Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation. At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse persp…