Director, Head of Manufacturing Sciences & Technology
Company: Adverum Biotechnologies
Location: Redwood City
Posted on: January 14, 2021
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
- 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
- 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
- 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
- Ability to build strong but flexible organizational structures
- Ability to effectively manage down to their teams, out to their
peers and up to the leadership.
- Requires excellent written and oral communication
- 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
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