Adverum Biotechnologies
Principal Scientist, Downstream Process Development (Contract) - AW
Adverum Biotechnologies, Inc., wholly owned subsidiary of Eli Lilly and Company, 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 Adverum's property. Adverum’s Talent Acquisition team must expressly engage agencies 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 Scientist, Downstream Process Development to join the Process Development team at our Redwood City, CA office. The individual will be part of the team responsible for developing and optimizing the downstream process development activities for adeno-associated virus (AAV) gene therapy programs. The successful candidate will participate in late-stage activities including design and optimization of the process as needed using historical batch data and manufacturing needs; process characterization; and tech-transfer of downstream processes to support clinical and commercial manufacturing. This role requires a deep understanding of chromatography, filtration, and gene therapy-specific challenges in AAV vector production, as well as experience in transitioning processes to GMP-compliant manufacturing.
What You’ll Do:
- Support late‑stage AAV downstream process development and optimization to ensure scalability, robustness, reproducibility, and regulatory compliance.
- Lead and execute purification development, including chromatography (AFF, IEX) and filtration (depth, NFF, TFF).
- Individually and partner with other SMEs to author protocols and reports, and execute on process characterization and validation studies (FMEA, scale‑down models, DOE/OFAT, PPQ, hold studies).
- Compile and analyze process and analytical data in Excel, JMP, or similar software, to identify trends, drive optimization, and lead and support investigations / RCA.
- Present study findings, issues, and trends to PD and cross-functional CMC teams.
- Support downstream material generation team as needed to maintain company timelines.
- Downstream SME to support external manufacturing operations including technical meetings, BPR and related records review, execution, and troubleshooting.
- Collaborate cross‑functionally (AD, USP, QC, RA) to ensure seamless transition from development to commercial.
- Provide line leadership if needed.
- Author/review technical documentation (development reports, SOPs, CMC sections for regulatory filings, Process Monitoring and Control Strategies).
- Stay updated on industry trends and emerging technologies in gene therapy manufacturing to maintain best-in-class process development practices.
About You:
- Ph.D. in Biochemistry, Chemical Engineering, Molecular Biology, or related field with 6+ years of relevant experience in downstream process development; or M.S. with 8+ years of experience.
- Proven experience in AAV or other viral vector production, preferably in late-stage development for clinical/commercial scale manufacturing.
- Strong expertise and in-depth knowledge in functioning and troubleshooting of purification process development/manufacturing equipment such as chromatography and filtration systems.
- Experience with scalable, AKTA, depth filtration, and TFF systems.
- Knowledge of GMP requirements and regulatory guidelines for gene therapy products.
- Prefer to have 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.
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