Director of Upstream Gene Therapy Development
2 days ago
Company Overview: Adverum Biotechnologies, Inc. is a clinical-stage gene therapy company focused on unmet medical needs in ophthalmology and rare diseases. Our expertise lies in clinical development, novel vector discovery, and in-house manufacturing.
About the Role: We are seeking a highly skilled Director of Upstream Gene Therapy Development to join our team at our Redwood City, CA office. This role offers a challenging opportunity for a talented professional to lead late-stage upstream process development for adeno-associated virus (AAV) gene therapy programs.
Responsibilities: As a key member of our Process Development team, you will be responsible for driving the design, optimization, and scale-up of upstream processes to support clinical and commercial manufacturing. Your expertise will be essential in transitioning processes to GMP-compliant manufacturing.
Key Responsibilities:
- Lead the late-stage development and optimization of upstream processes for AAV production, ensuring scalability, reproducibility, and compliance with regulatory standards.
- Design and execute experiments to optimize cell culture conditions, transfection parameters, and bioreactor performance.
- Develop scalable upstream processes compatible with GMP requirements, including suspension cell culture systems.
- Collaborate with cross-functional teams in analytical development, downstream processing, quality control, and regulatory affairs to ensure seamless transition from development to production.
- Provide technical expertise in troubleshooting and resolving upstream process issues, working closely with manufacturing teams.
- Support process characterization/validation studies (including FMEA, scale-down model establishment and DOE/OFAT approach to identify critical process parameters) and process performance qualification.
- Author and review technical documents, including development reports, SOPs, and CMC sections for regulatory filings.
Requirements: To succeed in this role, you will need a Ph.D. in Biochemistry, Chemical Engineering, Molecular Biology, or a related field with 6+ years of relevant experience in upstream process development; or an M.S. with 8+ years of experience. Proven experience in AAV or other viral vector production, particularly in late-stage development for clinical/commercial scale manufacturing, is essential.
Competitive Salary and Benefits: The salary range for this position is $160,000 USD to $185,000 USD annually, with the opportunity to earn an annual bonus. You will also be eligible to participate in our standard employee benefit programs, which include medical, dental, vision, 401k, STD/LTD, life and accident insurance, and paid time off.
Why Join Us? At Adverum, we value diversity, equity, and inclusion. We strive to create a workplace where everyone feels welcome, respected, and empowered to grow. If you share our passion for gene therapy and our commitment to innovation, please apply today.
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