Principal Scientist, Drug Substance Process Development & Manufacturing

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.

Heres 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
• 58 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 youll work closely with cross-functional teams and external partners to support the delivery of high-quality Drug Substance for clinical programs. Youll 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 creationone 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 perspectives to a shared goal of delivering better medicines to patients in need faster guided by our values and leadership behaviors.

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.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Companys internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.

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