Senior Scientist, Downstream Process Development (Gene Therapy)

TL;DR

Senior Scientist, Downstream Process Development (Gene Therapy): Developing and optimizing downstream purification processes for AAV gene therapy programs with an accent on scalability, robustness, and regulatory compliance. Focus on leading purification development using chromatography and filtration systems and transitioning processes to GMP-compliant manufacturing.

Location: On-site in Redwood City, CA (5 days a week)

Company

hirify.global is a clinical-stage gene therapy company, a subsidiary of Eli Lilly, focusing on developing durable therapies for ocular diseases.

What you will do

• Support late-stage AAV downstream process development and optimization to ensure scalability, robustness, and regulatory compliance.
• Lead and execute purification development, including chromatography (AFF, IEX) and filtration (depth, NFF, TFF).
• Execute process characterization and validation studies such as FMEA, scale-down models, DOE/OFAT, and PPQ.
• Analyze process and analytical data in Excel or JMP to identify trends and lead root cause investigations.
• Act as the Downstream SME to support external manufacturing operations, including BPR review and troubleshooting.
• Author and review technical documentation, including SOPs and CMC sections for regulatory filings.

Requirements

• Ph.D. in Biochemistry, Chemical Engineering, Molecular Biology (4-6+ years experience) or M.S. (8+ years experience).
• Proven experience in AAV or other viral vector production, preferably in late-stage development for clinical/commercial scale manufacturing.
• Strong expertise in troubleshooting purification equipment, specifically AKTA and TFF systems.
• Knowledge of GMP requirements and regulatory guidelines for gene therapy products.
• Experience authoring sections of regulatory submissions, including IND or BLA filings.
• Strong communication and leadership skills to manage cross-functional projects.

Nice to have

• Knowledge of DOE principles, process characterization, and BLA enabling activities.

Culture & Benefits

• Mission-driven environment aimed at establishing gene therapy as a standard of care for ocular diseases.
• Culture centered on inclusion and diversity, encouraging authenticity and professional growth.
• Opportunity to work within a company that is a wholly owned subsidiary of Eli Lilly and Company.