Cell Culture Process Development Engineer

Location
South San Francisco, CA, United States
Posted
Feb 13, 2021
Ref
5032170002
Required Education
Bachelors Degree
Position Type
Full time
JOB PURPOSE

Sana Biotechnology has an exciting opportunity for a Cell Culture Process Development Engineer. The Engineer will focus on the development of mammalian cell culture manufacturing processes to support production of viral vectors. The successful candidate will contribute to cell culture process design, process optimization, scale-up and scale-down model qualification, and technology transfer into pilot and GMP manufacturing. This role is expected to closely collaborate with multiple teams across Process and Analytical Development and Manufacturing.

DUTIES AND RESPONSIBILITIES
  • Design and execute process development experiments in shake flasks and single-use bioreactor systems at bench and pilot scale ranging from 15-mL to 200-L
  • Produce viral vector material to support cell line development, process and analytical development activities, and GLP Toxicology studies in support of a pipeline of cell and gene therapies
  • Support technology transfer to GMP manufacturing, including on-floor support as Person-In-Plant (PIP)
  • Analyze data, present conclusions and draft technical documents including process development reports, process descriptions, batch records, and standard operating procedures
  • Document all experimental work in an electronic laboratory notebook

QUALIFICATIONS

Basic Qualifications
  • BS in Chemical, Biological or Biomedical Engineering and 4 yrs or MS plus 1-2 yrs or equivalent combination of education and work experience
  • >2 years of experience with aseptic mammalian cell culture techniques
  • Hands-on experience with single-use rocking-motion and stirred-tank bioreactor operations and cell count/metabolite analyzers
  • Proven ability to perform experiments to optimize process parameters for improved yield and product quality
  • Strong troubleshooting, communication, and technical writing skills, disciplined record keeping, and the ability to self-motivate, multitask, meet frequently tight timelines, and work effectively with others in a dynamic multi-site environment
  • The candidate should be a team player, highly organized, and demonstrate curiosity, scientific rigor, and excellent problem-solving skills
  • Ability to engage in crucial conversations - providing and receiving feedback

Preferred Qualifications
  • Experience with automated high-throughput ambr15 or ambr250 bioreactor systems
  • Knowledge of engineering design principles for bioreactor scale-up and scale-down model qualification
  • Working knowledge of statistical Design of Experiments (DoE)
  • Experience in the production of viral vectors
  • Familiarity with cGMP manufacturing requirements and technology transfer activities
  • Demonstrate intense technical curiosity and a continuous drive to learn new skills and implement new technologies, including PAT

WORKING CONDITIONS
  • This is a hands-on lab position with some weekend work required
  • Some travel required to support tech transfer to manufacturing sites

PHYSICAL REQUIREMENTS
  • Able to lift up to 25 lbs.