Director, Process Development (Late-Stage Development)

Redwood City, CA Process Development Full Time

Adverum is looking for Director, Process Development to join the Process Development team at our Redwood City, CA office. This position reports directly into Head of Process Development and 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 Downstream PD team which is responsible for the development and optimization of the purification process(es) for Adverum’s clinical stage products (early and late phase).  As such, the incumbent will be expected to have a strong technical background knowledge of all downstream unit operations, including various filtration and chromatographic operations, as well as buffer chemistry, in-process pool formulation and stability.  A strong working partnership with peers in the other Process Development groups (Upstream, Drug Product), Analytical Development, Technology Transfer, External Manufacturing, Regulatory and Program Management will be key.  The incumbent will also be expected to lead and execute on various late-stage initiatives, including FMEA analyses, process characterization using DOE/QbD principals, and process performance qualification.  In addition, the ability of the incumbent to develop, motivate, and align a diverse team of scientists and engineers working on numerous projects will be vital to ensure the flexibility, efficiency, and success of the team.  Finally, the incumbent will also be expected to play a leading role in the TechDev team’s innovation development strategy, actively participating at conferences and with the wider AAV bioprocess field, helping to define and set Adverum’s process IP strategy.

This role requires strong, lead by example orientated leadership skills, a collaborative Team focus, the ability to juggle immediate needs with long term goals, and an ability to implement organizational structure to a dynamic, growing environment.  The incumbent is expected to be well versed in purification technologies for biologic therapeutics and experienced with managing groups in a development setting.  

What you'll do:

  • 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).  

About you:

  • 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.
About Us
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