Senior Scientist / Engineer I/II, Tech Transfer (Downstream Line)

Location
Redwood City, CA
Posted
Jun 08, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Adverum is looking for a Senior Scientist / Engineer I/II, Technology Transfer (TT) to join the Technology Development team at our Redwood City, CA office. This position reports directly into the Head of Tech Transfer and will play a key 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 helping to develop, implement, and then execute upon the operational vision for the Technology Transfer group.

In this role, the incumbent will be responsible for assisting with the planning and carrying the technology transfer process(es) and systems utilized by Adverum.  These activities will include tech transferring downstream processes between multiple internal parties (Candidate Process Development, Process Development, Pilot Process Development) and to external CDMO parties in partnership with the External Manufacturing and Supply Chain groups.  As such, the ability to quickly create strong working partnerships with peers and members of these groups, as well as with Analytical Development, Quality Control, Quality Assurance and Program Management, will be key for success.  This role will also include the ability to create and implement technology transfer tools that are flexible enough to be able to be used at any scale or site, but contain the required level of detail to successfully execute the process.  Finally, the incumbent will also be a key partner with External Manufacturing in supporting and managing our external CDMO partners for downstream operations.

This role requires a strong attention to detail, but also the capacity to see the larger picture, the ability to work collaboratively and efficiently with many cross-functional partners, and a strong organizational mind.  The incumbent is expected to be well versed in downstream processes and technology transfer, both internally and externally to the organization, and able to effectively work with and manage said partners that will have competing priorities.  Prior experience carrying out technology transfer activities for a viral gene therapy process is a plus.
What you'll do:
  • Perform various technology transfer activities for downstream processes at multiple scales and sites. 
  • Collaborate and work closely with the various Process Development teams, External Manufacturing and Supply Chain to understand customer requirements (both internal and external), develop strategic support plans and execute upon them.
  • Represent TT, and the larger MSAT 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 (downstream) to internal and external partners.
  • Partner with External Manufacturing to support and manage our external CDMO partners (when safe to travel an estimated 10-15% travel may be required).
  • Provide input, authorship and review on relevant CMC sections of various regulatory submissions as needed.
  • Review, edit and finalize technical documents such as SOPs, batch records and campaign reports.
  • Assist in drafting product impact assessments and review of deviation investigation reports.

About you:
  • B.S./M.S. in Chemical Engineering, Biological Engineering, Biochemistry, or appropriate technical discipline with 7+ yrs of relevant, industrial experience.
  • 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 in downstream operations such as chromatography and filtration operations. 
  • Prior experience in single-use systems for downstream manufacturing operations.
  • Prior experience leading technology transfer activities for the downstream manufacturing process.  Prior experience tech transferring to viral gene therapy CDMOs is a plus.
  • Strong background knowledge of GMP manufacturing operating requirements.
  • Strong background knowledge on downstream scaling parameters.
  • Ability to build strong, scalable (or scale-less) and flexible downstream processes and systems.
  • Ability establish productive relationships with a diverse set of peers, and lead by influence. 
  • Experience working with and drafting SOPs, batch records and protocols.
  • Proficiency in fostering synergistic and collaborative teams with an emphasis on building and supporting a strong company culture.
  • Represent Adverum and our process / CMC interests to external partners with professionalism.    

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