Principal Scientist, Downstream Process Development (Contract) - AW
About The Position
Adverum Biotechnologies, Inc., a subsidiary of Eli Lilly and Company, is seeking a Principal Scientist, Downstream Process Development to join their Process Development team. This role focuses on developing and optimizing downstream process development for adeno-associated virus (AAV) gene therapy programs. The successful candidate will be involved in late-stage activities such as process design and optimization, process characterization, and tech transfer to support clinical and commercial manufacturing. The position requires a strong understanding of chromatography, filtration, and AAV vector production challenges, along with experience in transitioning processes to GMP manufacturing.
Requirements
- 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.
- 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.
Nice To Haves
- Knowledge of DOE principles, process characterization, and BLA enabling activities.
- Background in authoring sections of regulatory submissions, including IND, or BLA filings.
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 protocols and reports, and execute process characterization and validation studies (FMEA, scale-down models, DOE/OFAT, PPQ, hold studies).
- Compile and analyze process and analytical data to identify trends, drive optimization, and lead/support investigations / RCA.
- Present study findings, issues, and trends to PD and cross-functional CMC teams.
- Support downstream material generation team to maintain company timelines.
- Act as a 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.
Benefits
- Eli Lilly and Company subsidiary benefits
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
Ph.D. or professional degree
