Principal Scientist Upstream Viral Vector Development
Posted on Apr 6, 2021 by Atara Biotherapeutics, Inc.
This position will work with the Technical Operations teams to design and develop approaches for both adherent and serum-free suspension processes for viral vectors (adenovirus, retrovirus, Epstein Barr Virus). This position will drive strategy, knowledge, and deliverables related to platform vector development, processes, and characterization that are required for CMC program milestone achievement. The ideal candidate has a proven track record in Matrix team leadership, CMC strategy, relationship-building & technical oversight of contract manufacturing organizations (CMOs. This is a highly visible role that will serve as the point of contact for program vector process and characterization strategy, for internal and external programs across our partner organizations (Process Sciences, Quality, Regulatory, Program teams). The incumbent will be accountable for the testing strategy that supports characterization, in-process testing, and safety testing of cell banks and vector used for Atara's Cell Therapy Programs.
Lead the development of vector platform development and control strategy within a cross-functional team in support of engineered T cell programs.
Authoring technical and regulatory documents. Drafting, reviewing, approving, and supporting regulatory filings, including IND amendments, BLAs, and regulatory responses
Proficient in ICH, FDA, EMA, and JP regulations and guidance. Expertise in USP, EP, JP, etc. regulations and guidance
Suitability of methods applied to viral vector screening and characterization methods
Provide leadership during vector transfers from internal and external groups to CDMO
Develop and lead strong collaborative relationships with internal and external groups
Assist in the development of standard operating procedures, justification of specifications, control strategies, and sampling plans in support of cell line banking and viral vectors
Mentors a group of diverse scientists and research associates to facilitate cross-functional training and collaboration, career development, and leading innovation in the viral vector arena.
Role model for Atara's Values of patients first, innovation teamwork, inclusion, community and mindset.
Education and Experience:
PhD. in Virology, Pharmaceutical Sciences, Engineering, Molecular Biology or equivalent with 7+ years of experience in applied virology in vector or vaccine development
Demonstrated experience with development and optimization of viral vector bioreactor (suspension) processes
Experience writing CMC sections for filings
Experience with viral risk assessments, viral safety testing and control strategies
Familiarity with development and/or commercialization of cell-based therapeutics
Basic understanding of cGMP requirements
Must be able to compose sound and well-reasoned written work and possess the ability to present technical information to both technical and non-technical audiences
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities