Late-Stage Process Development Director (Contract)

Adverum is a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the capabilities of its proprietary intravitreal platform, Adverum is developing durable, single-administration therapies, designed to be delivered in physicians’ offices, to eliminate the need for frequent ocular injections to treat these diseases. Adverum is evaluating its novel gene therapy candidate, ixoberogene soroparvovec (Ixo-vec), as a one-time, IVT injection for patients with neovascular or wet age-related macular degeneration. Additionally, by overcoming the challenges associated with current treatment paradigms for debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.

Note to Recruiters and Agencies

All recruiter and agency inquiries must go through Adverum’s internal Talent Acquisition team.  Unsolicited resumes sent to Adverum will be considered Adverum's property.   Adverum’s Talent Acquisition team must expressly engage agencies for any requisition.  Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.

Adverum is looking for a Director, Process Development (Late-Stage Development) to join Adverum at our Redwood City, CA office. This position will play a key leadership role to help advance Adverum’s lead program, Ixo-Vec, to commercial launch.  The incumbent will be responsible for developing, implementing, and then executing upon the operational vision for the PD group.

In this role, the incumbent will be responsible for organizing and developing the PD team, which handles Adverum’s late-stage product. The role requires a strong technical background in upstream and downstream unit operations, including bioreactors, filtration, chromatographic operations, buffer chemistry, in-process pool formulation, and stability.  The role also demands strong leadership skills, a collaborative team focus, the ability to juggle immediate needs with long-term goals, and the ability to implement organizational structure in a dynamic, growing environment. The incumbent should be well-versed in purification technologies for biologic therapeutics and experienced in managing groups in a development setting.

• 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). 

• 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% 

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 that allows for everyone in our Adverum Community to not only feel safe but also 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.