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).
Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.
Per Year Salary Range
$160,000-$224,000 USD
