Senior Scientist/Senior Engineer, Cell Therapy Process Development

6 days left

Location
South San Francisco, California, United States
Salary
Competitive
Posted
Nov 03, 2020
Closes
Dec 03, 2020
Ref
4936193002
Organization Type
Corporate
JOB PURPOSE

Sana Biotechnology has a unique opportunity within the Cell Therapy Process Development group for a motivated Sr. Scientist / Sr. Engineer. The candidate will help define the process development strategy for an early stage allogeneic chimeric antigen receptor T (CAR T) cell manufacturing process. He/she will lead a multidisciplinary group of engineers and research associates to execute the development plan and support manufacturing campaigns within the agreed upon timeline. The candidate will serve as subject matter expert for the key process unit operations. She/he will work in close alignment with the CMC program lead and report to the Principal Scientist leading CAR T cell process development. This role will collaborate closely with multiple cross-functional teams including Analytical Development, Research, Supply Chain and External Manufacturing to coordinate critical deliverables. The individual will also maintain a focus on 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 and Process leads.
  • Lead the execution of the allogeneic CAR T cell therapy process development plan.
  • Mentor, train and motivate a group of engineers and research associates to plan, execute and analyze experiments.
  • Provide expert opinions to justify process development decisions.
  • Act as primary SME for T cell expansion and bioreactor operations.
  • Draft, review and approve technical documentation including process descriptions, SOPs, MBRs.
  • Support internal and external process transfers.
  • Draft technical sections to support regulatory filings.
  • Evaluate new bioprocess technologies and implement process advancements for introduction into a GMP manufacturing environment.

QUALIFICATIONS

Basic Qualifications
  • Ph.D. in Chemical, Biological or Biomedical 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 with focus on cell culture.
  • Proven ability to lead a team of junior engineers and research associates.
  • Experience designing and scaling key cell therapy unit operations, especially T cell cultures within bioreactors.
  • Strong track record of applying fundamental engineering and scientific principles to process design, modeling and characterization.
  • Well versed with cGMP requirements and working in a regulated environment.
  • Advanced knowledge of immunology, especially T cell biology.
  • Working knowledge of statistical design of experiments (DoE).
  • 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 ≥3 direct reports.

Preferred Qualifications
  • Experience with T cell purification, lentiviral transduction, gene editing, cell harvest and cryopreservation unit operations design and scaling.
  • Well versed with current cell therapy manufacturing platforms.
  • Experience selecting raw materials and equipment suitable for cell therapy processes.
  • Familiarity applying PAT to cell therapy.
  • Proficient with relevant analytical methods including flow cytometry and cell-based assays.
  • Knowledge of high throughput T cell culture scale down models.
  • Experience with lentiviral vector manufacturing.
  • Familiar with R, Python, JMP and FlowJo software.

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

PHYSICAL REQUIREMENTS
  • Able to lift up to 25 lb.

DIRECT REPORTS
  • Up to 4 engineers or research associates

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