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Associate Director / Director, Head of Drug Product Process Development

Company: Adverum Biotechnologies, Inc.
Location: Redwood City
Posted on: June 6, 2021

Job Description:

Adverum is looking for an Associate Director / Director, Head of Drug Product Process Development (Drug Product PD) to join the Technology Development team at our Redwood City, CA office. This position reports directly into the VP of Technology Development (TechDev) and will play a key leadership role to help advance Adverum's lead program, ADVM-022, to commercial launch and our pipeline products into and through the clinic. The incumbent will be responsible for developing, implementing, and then executing upon the operational vision for the Drug Product PD group.

In this role, the incumbent will be responsible for organizing and developing the Drug Product PD team which is responsible for the development and optimization of the drug product manufacturing process(es), formulations and fill configurations for Adverum's clinical stage products (early and late phase). The incumbent will also be a key partner with Quality Control in supporting and executing on various DS/DP stability studies. As such, the incumbent will be expected to have a strong technical background knowledge of numerous unit operations and analytical technologies required, including various filtration and fill operations, formulation chemistry, biochemical and biophysical analytics, device and vial compatibility, and DS/DP stability. A strong working partnership with peers in Quality Control, Analytical Development, External Manufacturing, the other Process Development groups (Upstream, Downstream, Pilot & Candidate), Technology Transfer, Regulatory and Program Management will be key. The incumbent will also be expected to lead and execute on various late-stage initiatives, including CQA/FMEA analyses and process characterization using DOE/QbD principals. In addition, the ability of the incumbent to develop, motivate, and synergistically 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 the numerous divergent technologies and specialties needed to support drug product for biologic therapeutics, and experienced with managing groups in a development setting. Direct prior management experience of a drug product or formulation process development group, and/or prior experience with AAV drug product unit operations is a plus.

What you'll do: Provide overall leadership and vision to the Drug Product PD team. Organize and develop an efficient and flexible group that is able to develop numerous, diverse unit operations and analytics associated with a drug product process for viral gene therapy.Ensure the Drug Product PD team is properly staffed, structured, and resourced, and that its members are appropriately developed and supported for success in order to deliver on strategic plans. Collaborate and work closely with Quality Control, Analytical Development, External Manufacturing, other Process Development teams, Technology Transfer, Regulatory and Program Management to understand customer requirements (both internal and external), develop strategic support plans and execute upon them.Build out a Drug Product PD lab (both hardware and software) to enable an efficient and powerful scientific working group. Establishment and inclusion of appropriate scale-down models, accelerated stability models, and new drug product focused analytics is expected.Conduct and lead late-stage development activities for Adverum's lead program, including CQA, FMEA and process characterization.Discover, evaluate, and implement new technologies to establish next generation AAV manufacturing processes. Work with Quality Control partners to define, implement and support various DS/DP stability studies.Provide input, authorship, and review on relevant CMC sections of various regulatory submissions as needed.Represent Drug Product PD, and the larger TechDev organization, to the program teams, external stakeholders and the LT, preparing materials and presenting as needed.Serve as a subject matter expert (SME) for the drug product process to internal and external partners.Mentor, develop and support a passionate team of individuals focused on high performance.

About you:Ph.D. in Formulation Science, Biochemistry, Chemical Engineering, Biological Engineering, or appropriate technical discipline with 7+ yrs of relevant, industrial experience (M.S./B.S. in corresponding fields with 12+ yrs).Prior experience and expertise working on the drug product development of protein-based therapeutics and/or vaccines. Prior experience working on the drug product development of AAV products is a plus.Prior experience working in an industrial process development, and/or device and formulation development environment. Prior experience managing and leading said group(s). Prior experience managing a formulation or drug product team is a plus.Prior experience with CQA and FMEA exercises. Prior experience with late-stage process characterization activities is a plus.At least 2 years of management experience.Strong background experience working with and/or in a DP fill, GMP operating environment, and prior experience with technology transfer activities. Ability to build strong but flexible organizational structures and systems.Ability to effectively manage down to their teams, out to their peers and up to the leadership. Requires excellent written and oral communication capabilities.Desire to build synergistic and collaborative teams with an emphasis on building and supporting a strong company culture.Desire to mentor and develop members of their team.

Keywords: Adverum Biotechnologies, Inc., Redwood City , Associate Director / Director, Head of Drug Product Process Development, Other , Redwood City, California

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