Senior Scientist, T cell Process Development

Location
South San Francisco, CA, United States
Posted
Apr 29, 2021
Ref
5234135002
Required Education
Associate Degree
Position Type
Full time
JOB PURPOSE

Sana Biotechnology is seeking an innovative and highly motivated Senior Scientist to contribute to process development of allogeneic T cell products. As a member of the Cell Culture Technical Operations organization, he/she will be part of a team to understand critical variables and optimize unit operations in the T cell manufacturing process, with a key focus on starting material characterization. This individual will partner closely with the Principle Scientist leading T cell process development efforts and work in alignment with the CMC program lead. The role is in a highly collaborative and rapidly evolving environment, entailing interfaces with multiple teams and stakeholders across research, process development and manufacturing. He/she will also contribute to innovation and process improvements to develop next generation allogeneic T cell manufacturing processes.

DUTIES AND RESPONSIBILITIES
  • Define process development strategy in close collaboration with the CMC team and Process leads
  • Develop scale down model for the T cell isolation unit operations, establishing linkage to subsequent downstream processing steps
  • Determine critical quality attributes of starting materials that impact final T cell product, in close collaboration with Research
  • Collaborate with Supply Chain and Manufacturing to manage and screen starting materials to support GMP production
  • Draft, review and approve technical documentation including process descriptions, SOPs and batch records
  • Support internal and external process transfers to CDMOs
  • Author and review relevant sections of documentation in support of IND and BLA submissions, amendments, and briefing documents
  • Present process information and data to Research, CMC and program teams
  • Contribute to innovation of CAR T manufacturing process to improve quality, robustness and/or yield
  • Mentor, train and supervise research associates and engineers

QUALIFICATIONS

Basic Qualifications
  • Ph.D. in Immunology, Chemical/Biological Engineering plus 5 years of industry experience or equivalent
  • >5 year of progressive experience in cell therapy process development, preferably with clinical and commercial stage T cell therapy processes
  • Experience designing and scaling key T cell process unit operations, including development of fit-for-purpose scaledown models
  • Knowledgeable about T cell product attributes and composition, including understanding of analytical methods for characterization
  • Strong track record of applying fundamental engineering and scientific principles to process design, modeling and characterization.
  • Well versed with cGMP requirements and prior experience transferring methods and/or processes to cGMP manufacturing
  • Advanced knowledge of immunology, especially T cell biology
  • Working knowledge of statistical design of experiments (DoE) and analysis of large data sets
  • Excellent technical written and oral communication skills
  • Effective collaborator with an agile mindset to thrive in a fast-paced, multi-site, team-oriented organization
  • Prior experience managing 1-2 direct reports
  • Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines with excellent time management and organizational skills
  • Lead with curiosity and influence across functional and organizational lines
  • Ability to effectively work through change and ambiguity
  • Ability to engage in crucial conversations - providing and receiving feedback

Preferred Qualifications
  • Experience with T cell lentiviral transduction, gene editing, cell harvest and cryopreservation unit operations design and scaling
  • Well versed with current cell therapy manufacturing platforms and technologies
  • Experience selecting raw materials and equipment suitable for cell therapy processes, familiarity with ICH Q10
  • Experience applying Quality by Design (QbD) concepts, conducting late stage process development and supporting BLA submissions
  • Proficient with R, Python, JMP and FlowJo software

WORKING CONDITIONS
  • This position requires handling of human blood products
  • Up to 50% time in-lab work
  • Some weekend work required
  • Travel up to 25% of the time

PHYSICAL REQUIREMENTS
  • Able to lift up to 25 lb.