Principal Scientist, Late-Stage Upstream Process Development

Adverum Biotechnologies, Inc. is a mission-driven clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies designed to be delivered in physicians’ offices to eliminate the need for frequent ocular injections to treat these diseases. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.

Note to Recruiters and Agencies

All recruiter and agency inquiries must go through Adverum’s internal Talent Acquisition team. Unsolicited resumes sent to Adverum will be considered property of Adverum. Agencies must be expressly engaged by Adverum’s Talent Acquisition team for any requisition. Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.

Adverum is looking for a Principal/Senior Pr. Scientist, Late-Stage Upstream Process Development to join the Process Development team at our Redwood City, CA office. The individual will be responsible for leading late-stage upstream process development for adeno-associated virus (AAV) gene therapy programs. The successful candidate will drive the design, optimization, and scale-up of upstream processes to support clinical and commercial manufacturing. This role requires a deep understanding of cell culture, bioreactor and AMBR systems, and gene therapy-specific challenges in AAV vector production, as well as experience in transitioning processes to GMP-compliant manufacturing.

What you'll do:

• 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, including review of development, manufacturing, process characterization and validation protocols and reports.
• Support the development and implementation of an (upstream and downstream) process monitoring/control strategy program using appropriate statistical guidelines.
• Author and review technical documents, including development reports, SOPs, and CMC sections for regulatory filings.
• Stay updated on industry trends and emerging technologies in gene therapy manufacturing to maintain best-in-class process development practices.
• Manage internal lab operations and lead direct reports.

About you:

• Ph.D. in Biochemistry, Chemical Engineering, Molecular Biology, or related field with 6+ years of relevant experience in upstream process development; or 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.
• Strong expertise in cell culture, bioreactor design and operation, and viral vector transfection techniques.
• Experience with scalable, single-use bioreactor and AMBR systems.
• Knowledge of GMP requirements and regulatory guidelines for gene therapy products.
• Must-have advanced knowledge of DOE principles, process characterization, and BLA enabling activities.
• Background in authoring sections of regulatory submissions, including IND, or BLA filings.
• Excellent problem-solving skills with the ability to troubleshoot and optimize complex bioprocesses.
• Strong communication and leadership skills to manage cross-functional projects and mentor team members.

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create a space that allows everyone in our Adverum Community to not only feel safe but also encouraged to speak, learn from each other, grow in their professions, and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion, or sexual orientation.