Principal Scientist (mAB Development)

TL;DR

Principal Scientist (mAB Development): Leading drug substance process development and manufacturing activities for monoclonal antibodies with an accent on MS&T, tech transfer, and GMP execution. Focus on designing scale-up studies, managing CDMO partnerships, and leveraging AI-driven tools to optimize CMC workflows.

Location: Must be based in or able to commute to Somerville, MA (Hybrid: 1-2 days/week in office).

Salary: $160,000–$224,000 USD

Company

hirify.global is a clinical-stage generative biology company pioneering the AI revolution in drug design and development.

What you will do

• Support drug substance process development including upstream expression, purification, and viral clearance.
• Design and execute scale-up, process characterization, and PPQ-enabling studies.
• Manage tech transfer and provide person-in-plant support for GMP campaigns at CDMOs.
• Author and review GMP documentation such as batch records, deviations, and CAPAs.
• Provide technical leadership for GMP manufacturing and drive continuous process improvement.
• Integrate AI-driven tools for knowledge management and data analysis in CMC workflows.

Requirements

• PhD or MS in Chemical Engineering, Biochemistry, or related field.
• 5–8 years of industry experience in drug substance process development or GMP manufacturing.
• Hands-on experience with GMP documentation and quality systems.
• Proven ability to manage CDMO relationships and support tech transfer.
• Strong technical writing and data analysis skills.
• Familiarity with regulatory requirements for biologics and QbD principles.

Nice to have

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

Culture & Benefits

• Opportunity to work at the intersection of AI and generative biology.
• Competitive base salary with annual bonus and equity compensation.
• Comprehensive benefits package.
• Collaborative cross-functional environment focused on clinical-stage programs.