Associate Director/Director, Drug Product, PD
Redwood City, CA, United States
Associate Director/Director, Drug Product, PD Redwood City, CA Technical Operations Full Time
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 is a key leadership role that focuses on advancing Adverum’s lead program, ADVM-022, from phase III through commercial launch. The incumbent will be responsible for developing, implementing, and then executing the vision of the drug product technical development plan for the Drug Product PD group.
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. Support DP PPQ-related activities.
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 key
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 4 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 emphasizing building and supporting a strong company culture.
Desire to mentor and develop members of their team.
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