Director, Head of Manufacturing Sciences & Technology

Company: Adverum Biotechnologies
Location: Redwood City
Posted on: January 14, 2021

Job Description:

Senior Director, Head of Manufacturing Sciences & Technology Redwood City, CA / Technology Development - Manufacturing Sciences & Technology / Adverum is looking for a Senior Director, Head of Manufacturing Sciences and Technology (MSAT) to join the Technology Development (TechDev) team at our Redwood City, CA office. This position reports directly into the VP of 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 MSAT group. In this role, the incumbent will be responsible for organizing and ensuring proper alignment of scientific and technological resources of both the Technology Transfer and Pilot Process Development groups within MSAT. A strong working partnership with peers in Process Development, Manufacturing, Analytical Development and Program Management will be key for success. As such, the ability to fluidly move themselves and MSAT group members between GMP, GLP and development operating environments will be essential. This role requires strong, vision orientated leadership skills, long term strategic thinking, a collaborative Team focus, and an ability to implement organizational structure to a dynamic, growing environment. The incumbent is expected to be well versed in technology transfer, both internally and externally to the organization, and experienced with managing groups in a manufacturing or large-scale development setting. Prior experience providing process development support to a commercial manufacturing facility is a plus. What you'll do:

• Provide overall leadership and vision to the MSAT organization, which includes the Technology Transfer and Pilot Process Development groups.
• Ensure that MSAT and its teams are properly staffed, structured, resourced, and supported for success in order to deliver on strategic plans.--
• Develop, implement, and execute on the operation vision for the MSAT group. This will include updating the vision as MSAT continues to grow to meet evolving deliverables, including the addition of new teams.
• Collaborate and work closely with Process Development, Manufacturing, Analytical Development and Program Management to understand customer requirements (both internal and external), develop strategic support plans and execute upon them.
• Help to define and implement Adverum's technology transfer process(es) and systems.
• Help to organize and develop an efficient and flexible pilot PD group that is able to meet various types of material deliverables while also conducting process development activities at large-scale.
• Represent MSAT, 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 at scale process to internal and external partners.
• Provide input, authorship and review on relevant CMC sections of various regulatory submissions as needed. About you:
  • Ph.D. in Chemical Engineering, Biological Engineering, Biochemistry, or appropriate technical discipline with 10+ yrs of relevant, industrial experience (M.S./B.S. in corresponding fields with 15+ yrs).
  • Prior experience and expertise working on the production of protein-based therapeutics and/or vaccines. Prior experience working on viral gene therapy products is a plus.
  • Prior experience working in industrial process development, GMP manufacturing and/or pilot plant environments. Prior experience supporting commercial manufacturing is a plus.
  • Prior experience managing and leading said group(s).
  • Prior experience with technology transfer activities to manufacturing groups. Prior experience tech transferring to viral gene therapy CDMOs is a plus.
  • At least 5 years of management experience, with a significant amount of that time being associated with management of a larger group. Prior experience managing managers is a plus.
  • Strong background knowledge of GMP, GLP and Development lab operating requirements.
  • 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. 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

Keywords: Adverum Biotechnologies, Redwood City , Director, Head of Manufacturing Sciences & Technology, IT / Software / Systems , Redwood City, California