Principal Scientist, Late-Stage Upstream Process Development

Company: Adverum Biotechnologies, Inc.
Location: Redwood City
Posted on: November 18, 2024

Job Description:

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.Compensation:
    • The salary range for this position is $160,000 USD to $185,000 USD annually, with the opportunity to earn an annual bonus. This salary range is an estimate, and the actual salary may vary based on a candidate's qualifications, including education, length of experience, location, and market data. Employees in this position are eligible to participate in the applicable Company equity incentive award plan. The amount of incentive varies and is subject to the terms and conditions of the plan. Employees in this position are eligible to participate in the Company's standard employee benefit programs, which currently include the following: medical, dental, vision, 401k, STD/LTD, life and accident insurance, and either paid time off or flexible paid time off.Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum's core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but 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.
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Keywords: Adverum Biotechnologies, Inc., Walnut Creek , Principal Scientist, Late-Stage Upstream Process Development, Other , Redwood City, California