Senior Scientist, Downstream Process Development (Contract) - AW

About the role

Adverum Biotechnologies, Inc., wholly owned subsidiary of Eli Lilly and Company, is seeking a Senior Scientist, Downstream Process Development to join the Process Development team at our Redwood City, CA office.

Responsibilities

• 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).
• Author/review technical documentation (development reports, SOPs, CMC sections for regulatory filings, Process Monitoring and Control Strategies).
• Collaborate cross-functionally (AD, USP, QC, RA) to ensure seamless transition from development to commercial.
• Provide line leadership if needed.
• Support downstream material generation team as needed to maintain company timelines.
• Support external manufacturing operations including technical meetings, BPR and related records review, execution, and troubleshooting.
• Present study findings, issues, and trends to PD and cross-functional CMC teams.

Requirements

• Ph.D. in Biochemistry, Chemical Engineering, Molecular Biology, or related field with 4-6+ 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.
• Experience with 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.

Qualifications

• Deep understanding of chromatography, filtration, and gene therapy-specific challenges in AAV vector production.
• Experience in transitioning processes to GMP-compliant manufacturing.

Skills

• Expertise in AAV or other viral vector production.
• Strong problem-solving and troubleshooting skills.
• Excellent communication and leadership abilities.

Benefits

Adverum offers a competitive compensation package, including a salary range of $70 - $90 per hour, along with comprehensive benefits.

Pay

$70 - $90 an hour

Schedule

Onc-site 5 days a week