Adverum Biotechnologies
We are on a global mission to establish gene therapy as a new standard of care for highly prevalent ocular diseases.
Gene Therapy • Biotechnology • Rare Diseases • Ophthalmology • Retina
51 - 200
Director, Downstream Process Development (Late Stage Development)
July 24
🏢 In-office - Bay Area
Adverum Biotechnologies
We are on a global mission to establish gene therapy as a new standard of care for highly prevalent ocular diseases.
Gene Therapy • Biotechnology • Rare Diseases • Ophthalmology • Retina
51 - 200
Description
• Lead the Downstream Process Development group to develop globally compliant, robust, well-characterized, scalable and high quality AAV production platform to support both internal and external (CDMO) manufacturing requirements for clinical and commercial programs. • Lead 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. • Oversees the development and implementation of an (upstream and downstream) process monitoring/control strategy program using appropriate statistical guidelines. • Technical management of development operations at Contract Development and Manufacturing Organization (CDMOs). • Collaborate and work cross-functionally with Manufacturing, Regulatory Affairs, Assay Development, Finance, and Quality functions to ensure all activities are scheduled and executed on time in accordance with program timelines. • Identify, evaluate, and implement novel technologies and systems in the development of Adverum’s manufacturing platforms. • Build and maintain collaborative working relationships with CMOs, including managing contracts. • Serve as subject matter expert and provide technical expertise to process related troubleshooting, and Quality support. • Support authoring efforts for specific CMC sections of regulatory filings (including INDs, comparability packages, BLA’s, and formal responses to regulatory inquiries).
Requirements
• Ph.D. in biochemical engineering, biochemistry, or appropriate technical discipline with 8+ years (MS with 10+ years) of industrial bioprocess development experience. • Demonstrated experience with track record of success leading technical teams, experience in process scale-up and development of scale-down models. • Must-have advanced knowledge of DOE principles, process characterization, and BLA submission. • Proven leadership experience and strong people management skills with the desire and ability to deliver on objectives while developing people in a dynamic and fast-paced environment. • Broad experience in cGMP biologics manufacturing and understanding of regulatory guidelines. • Strong background and subject matter expertise in purification unit operations including column chromatography, filtration (TFF), harvest and viral clearance validation. Upstream (cell culture, bioreactor) experience is a plus. • Ability to communicate effectively and connect with all levels of the organization. • Strong project leadership and resource management skills. • Require excellent written/oral communication.
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