Principal Scientist, Drug Substance Process Development & Manufacturing (Biotech)

TL;DR

Principal Scientist, Drug Substance Process Development & Manufacturing (Biotech): Support monoclonal antibody drug substance development with MS&T focus, bridging process development, scale-up, tech transfer, and GMP manufacturing execution. Focus on upstream and downstream operations, CDMO management, quality systems, and leveraging AI-driven tools for knowledge management and data analysis.

Location: Somerville, MA with flexibility for hybrid work (1-2 days a week in the office)

Salary: $160,000–$224,000 USD

Company

Clinical-stage generative biology company pioneering the AI revolution in drug design and development.

What you will do

• Support drug substance process development and manufacturing activities including upstream expression, purification, UF/DF, and viral clearance
• Design and execute scale-up, process characterization, and PPQ-enabling studies
• Own tech transfer and provide person-in-plant support for GMP campaigns at CDMOs
• Review and author GMP documentation such as batch records, change controls, deviations, and CAPAs
• Provide technical leadership for GMP manufacturing, troubleshooting, and data-driven decisions
• Partner cross-functionally with CMC, QA, Regulatory, and Supply Chain teams
• Drive continuous process improvement and process robustness initiatives

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 biotech/pharma
• Strong attention to detail and ability to analyze complex technical data
• Excellent communication and technical writing skills
• Experience with CDMOs, tech transfer, and regulatory submissions
• Hands-on experience with GMP documentation and quality systems (deviations, change control, CAPA)
• Demonstrated ability to lead complex technical programs and collaborate in cross-functional teams
• Familiarity with regulatory issues, process validation, QbD principles, and industry trends for biologics

Nice to have

• Experience supporting BLA/IND submissions
• Exposure to accelerated development environments for early to late-stage programs

Culture & Benefits

• Work closely with cross-functional teams and external partners on clinical programs
• Broaden exposure to late-stage CMC activities and leading CDMOs
• Annual bonus, equity compensation, and competitive benefits package
• Collaborate across disciplines guided by values and leadership behaviors
• Contribute to innovative biologics transforming medicine through Generative Biology