Senior Associate Scientist, Process Design
Santa Monica, CA, USA | Leading Pharmaceutical / Biotech Company
Industry:Pharmaceutical / Biotech
Job Description:1 people have viewed this job
Kite is seeking a highly motivated individual with cell culture experience to work on innovative T cell therapy for cancer treatment.As a Senior Associate Scientist in Process Design, you will provide process development support for New INDs, technology transfers, process validations and GMP manufacturing for Kite’s engineered autologous T cell therapy products. Additionally, you will draft and review protocols, production procedures, and process development reports.You will work with the Process Development team to design and scale-out cell therapy processes, manage equipment qualification and support process validation, as well as draft documentation for regulatory filings to advance Kite’s product portfolio.
Hands on execute and collaborate on process design laboratory studies to support process development, optimization and characterization and essential process improvements.
Perform hands on work in a cell culture lab and process training for GMP clinical production.
Participate and influence a cross-functional development team to advance CMC activities
Perform process analysis and trend process performance
Develop manufacturing processes for cell therapy products
Design and execute process development studies to develop a thorough understanding of operating and performance parameters
Perform statistical analysis including design of experiments (DOEs) as appropriate
Write and review technical documentation from writing technical SOPs, draft manufacturing batch records, technical reports and summary reports.
Create slides and supporting data to communicate results to senior leadership.
Other duties as assigned
PhD Degree in Biology, biochemistry, chemical engineer, biomedical engineering or biotechnology degree or related discipline with 1-3 years of pharmaceutical manufacturing, technology transfer & process development experience required
Demonstrated cell culture and aseptic processing experience is required including basic cell culture lab techniques such as cell passaging, cryopreservation, formulation of media, aseptic technique using a BSC, cell counting, and managing reagents.
Practical knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices.
Practical demonstration of hands on process development including use of statistical design of experiments is required. Experience with bioreactors is desired.
Mastery of scientific and engineering principles
Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development
Ability to think critically, and demonstrated troubleshooting and problem solving skills
Excellent interpersonal, verbal and written communication skills are required.
Ability to function efficiently and independently in a changing environment
Self-motivated, strong sense of responsibility, and willing to accept temporary responsibilities outside of initial job description
Well-developed computer skills