Adverum Biotechnologies · 5 months ago
Late-Stage Process Development Director (Contract)
Redwood City, CA
Contract
Hybrid
Director/Executive
$96/hr - $105/hr
10+ years expAdverum Biotechnologies, Inc. is a clinical-stage company focused on establishing gene therapy as a new standard of care for ocular diseases. They are seeking a Director of Process Development to lead the late-stage development group, ensuring the advancement of their lead program, Ixo-Vec, to commercial launch through effective team management and operational strategy implementation.
BiotechnologyPharmaceuticalTherapeutics
Responsibilities
Lead the late-stage 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
Leading and executing various late-stage initiatives such as FMEA, process characterization using DOE/QbD principles, and oversee process performance qualification, including review of development, manufacturing, process characterization and validation protocols and reports
Developing, motivating, and aligning a diverse team of scientists and engineers working on numerous projects to ensure flexibility, efficiency, and success
Oversee the development and implementation of a (upstream and downstream) process monitoring/control strategy using appropriate statistical guidelines
Maintain collaborative working relationships and oversee Technical management of development operations at Contract Development and Manufacturing Organization (CDMO)
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
Serve as a subject matter expert and provide technical expertise to evaluate process-related deviations and manufacturing challenges
Support authoring efforts for specific CMC sections of regulatory filings (including INDs, comparability packages, BLA’s, and formal responses to regulatory inquiries)
Qualification
Required
Ph.D. in biochemical engineering, biochemistry, or appropriate technical discipline with 10+ years (MS with 15+ years) of industrial bioprocess development experience
AAV experience is preferred; working with CMO and late-stage experience is required
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 upstream and purification unit operations including column chromatography, filtration (TFF), harvest and viral clearance validation
Ability to communicate effectively and connect with all levels of the organization
Strong project leadership and resource management skills
Require excellent written/oral communication
Travel up to 25%
Preferred
AAV experience is preferred
Company
Adverum Biotechnologies
Adverum Biotechnologies is a gene therapy company that focuses on developing medicines that can offer therapeutic benefits to patients.
51-200 employees
H1B Sponsorship
Adverum Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2022 (1)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$814.87MKey Investors
TCG CrossoverVenrock
2025-10-24Acquired
2024-02-05Post Ipo Equity· $127.5M
2020-08-11Post Ipo Equity· $217M
Leadership Team
MARK L. LUPHER, JR.
Director
Romuald Corbau
Chief Scientific Officer
Recent News
The Motley Fool
2025-12-24
2025-12-22
Venture Capital
2025-12-10
Company data provided by crunchbase