Senior Engineer, Manufacturing Science and Technology (Biotech)

TL;DR

Senior Engineer, Manufacturing Science and Technology (Biotech): Supporting technical and strategic initiatives to advance internal and external manufacturing activities from late-stage development through commercialization with an accent on GMP manufacturing outcomes and process control strategies. Focus on troubleshooting GMP outcomes, implementing integrated control strategies for CAR-T therapies, and ensuring regulatory compliance during technology transfers.

Location: Onsite in Newark, CA. Candidates must be authorized to work in the U.S.

Salary: $120,000 – $145,000 per year

Company

hirify.global is a clinical-stage biotechnology company pioneering the development of allogeneic CAR T cell products for cancer and autoimmune diseases.

What you will do

• Troubleshoot and continuously improve GMP manufacturing outcomes for internal and external manufacturing partners.
• Execute PPQ-enabling activities, including Process Control Strategy and PPQ protocols.
• Develop and implement integrated control strategies for allogeneic CAR-T therapies and starting materials.
• Support technology transfers by applying advanced scientific principles to meet Process Development and Manufacturing needs.
• Provide process requirement inputs to support business cases and capital project decision-making.
• Collaborate with Quality, Facilities, Engineering, and IT to ensure cross-functional alignment and timely product release.

Requirements

• Bachelor’s degree in Science or Engineering.
• Minimum 8 years of directly related GMP pharmaceutical manufacturing experience.
• Must be authorized to work in the U.S.
• In-depth knowledge of GMP and regulatory expectations.
• Proven experience with regulatory inspections and providing technical justifications for manufacturing deviations.

Nice to have

• Experience in late-stage clinical and commercial manufacturing environments.
• Direct experience with cell therapy, viral vectors, gene-editing, or cellular starting material manufacturing.

Culture & Benefits

• Comprehensive compensation package including an annual performance bonus and equity.
• Full health insurance coverage.
• Generous time off, including two annual company-wide holiday shutdowns.
• Collaborative work environment focused on delivering life-changing therapies to patients.