Principal Scientist, Process Sciences (Biotech)

TL;DR

Principal Scientist, Process Sciences (Biotech): Leading the Pilot Plant function to translate process development strategies into scalable cell therapy manufacturing operations with an accent on scale-up, process characterization, and technology transfer. Focus on mitigating scale-dependent risks, optimizing closed aseptic automation strategies, and driving end-to-end process integration.

Location: South San Francisco, CA (Onsite). Must be authorized to work in the U.S.

Salary: $155,000 - $180,000 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

• Lead the Pilot Plant team, overseeing large-scale engineering runs for process development and technology transfer.
• Translate process strategies into robust, at-scale cell therapy manufacturing operations.
• Design and execute high-impact process characterization studies using QbD principles.
• Identify and mitigate scale-dependent risks for platforms like Sepax, Xuri, and Prodigy to ensure process performance.
• Develop and implement closed, aseptic automation strategies and optimize platform-specific systems.
• Collaborate with Drug Product, Manufacturing, and MSAT functions to ensure robust technology transfer to GMP.

Requirements

• Ph.D. in Chemical Engineering, Bioengineering, or related field (7+ years exp), MS (10+ years), or BS (12+ years).
• Extensive experience in process development and scale-up for biologics or cell therapy manufacturing.
• Demonstrated expertise in process characterization, DOE, and data-driven decision making.
• Proficiency in Python or R for analysis of complex datasets and automation solutions.
• Strong understanding of cell therapy processes, including gene editing, viral transduction, and cell expansion.
• Must be authorized to work in the U.S.

Culture & Benefits

• Annual performance bonus and equity.
• Comprehensive health insurance package.
• Generous time off, including two annual company-wide holiday shutdowns.
• Collaborative work environment with a team of talented professionals in biotechnology.