Manager, Pilot Process Development (Upstream)

Location
Redwood City, CA
Posted
Jun 04, 2021
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Adverum is looking for a Manager/Sr. Manager, Pilot Process Development (PPD), Upstream Line, to join the Manufacturing Sciences and Technology (MSAT) team at our Redwood City, CA office.  This position will report into the Head of the PPD group and will be a key team member to help advance Adverum’s lead program, ADVM-022, to commercial launch and to move our pipeline products into and through the clinic. 

In this role, the incumbent will be responsible for the planning, preparing and managing of day to day activities associated with the upstream production of AAV based products and expansion of baculovirus seed stocks, from small flask to pilot and production scales.  These activities will include thaw & recovery of cell and viral banks, expansion and maintenance of said banks, infection of the production bioreactor to produce AAV, maintenance and monitoring of the production bioreactor, and harvest.  This role is also responsible for set-up and cleaning of required equipment, sample taking and analysis for monitoring of cell cultures, and appropriate record keeping of activities. 

Given the breadth of activities involved, this role requires the ability to quickly learn, understand and master the overall AAV manufacturing process and operations and to be able to provide guidance and training to team members.  The incumbent is expected to mentor and motivate team members and build a cohesive and high-performance PPD upstream team. In addition, the incumbent is expected to collaborate effectively within and alongside of the MSAT organizations.  Prior management experience is required. Prior experience working in a biologics product-based pilot plant, or in an upstream process development role, is a plus.
What you'll do:
  • Ensure safe workplace and be compliant with company and EHS rules and local regulations.
  • Plan and prepare pilot scale upstream runs, for either material production or development.
  • Lead upstream team and execute each run flawlessly.
  • Ensure appropriate documentation while executing batch records.
  • Conduct data analysis and trending and identify improvement opportunities.
  • Collaborate with PPD downstream team closely and identify cross-training opportunities.
  • Author, review, revise, and approve upstream documents (SOPs, batch records, campaign reports, technical study plans/reports).
  • Work with QA on documentation reviews, change controls, OOS resolution, and CAPA.
  • Ensure training and cross-training of team members on all upstream operations.
  • Solid understanding of the biology as related to AAV production process.
  • Support technology transfer as needed.
  • Other responsibilities assigned by management.

About you:
  • B.S./M.S. in Chemical/Biochemical Engineering, Biological Engineering, Biochemistry, Microbiology, Biology or appropriate technical discipline with 10+ years of relevant, industrial experience or Ph.D with 5+ years industrial experience.
  • At least 3 years prior experience in managing team is required.
  • Strong organization, interpersonal and communication skills.
  • Strong desire to build a cohesive and high-performance team.
  • Prior experience in drafting and reviewing SOPs, batch records, and technical plans/reports are required.
  • Prior experience in the production or process development of protein-based therapeutics and/or vaccines is required. Prior experience working in upstream pilot plant setting is a plus.
  • Hands on experience working with cell culture, aseptic techniques, shake flask and/or bioreactors, depth filtration and tangential flow filtration.
  • Ability to stay focused on priorities and be flexible to quickly adjust to company’s changing needs/priorities.

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