Process Engineer, Process Development - Cell Culture/Biologics

  • Location
    San Francisco, California
  • Job type
    Contract/Temporary
  • Category
    Medical & Science - Pharmaceutical - Clinical

Process Engineer, Process Design - Cell Culture/Biologics
Job Description
Adecco Medical and Science is seeking a highly motivated individual with cell culture process development experience to work on innovative T cell therapy for cancer treatment. As a Process Engineer, Process Design, you will provide process development and engineering support for process design and development, process characterization, process analysis, and leading process improvements in GMP manufacturing. Primary responsibility will be to support technical projects and cross-functional teams to develop, characterize and improve the manufacturing process. Activities will be performed to identify and define critical process parameters and process ranges, improve process robustness and reduce production cost. You will be expected to contribute new ideas and innovative solutions to technical challenges. Additionally, you will draft and review study plans and reports, analyze and trend process data, perform Design of Experiment (DoE) , and provide technical support for process changes. You will work with the Process Science & Engineering team to design and scale-out cell therapy processes, and support process characterization, process analysis, process improvements, as well as draft documentation supporting regulatory filings to advance Kite’s product portfolio.

Responsibilities:

Support execution of technical projects to develop, characterize and improve the manufacturing process
Use statistical methods to perform process analysis
Planning, scheduling, and project management of technical projects and cross-functional teams
Lead and execute laboratory studies to support process design and development, characterization and process improvements
Perform hands on work in a cell culture lab
Author development plans, reports and documentation used to support regulatory submissions and process changes
Design and execute process development studies to develop a thorough understanding of operating and performance parameters
Act as technical expert to train and supervise technical personnel
Other duties as assigned

Requirements:

Bachelor’s or Master’s Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biological Sciences or related discipline with a minimum of 2+ years’ process development experience in industry
Experience with T Cell Biology, Immunology and Immunotherapy is highly desired.
Knowledge and experience designing, developing, analyzing, scaling-up and troubleshooting cell culture manufacturing processes involving bioreactors, fermenters, wave bags, purification systems, and cryopreservation of cells.
Experienced with statistical methods of process analysis
Familiarity with statistical software such as JMP and Minitab
Process modelling and simulation experience
Fluency with cGMP manufacturing and regulatory agency regulations and requirements for biologics, pharmaceuticals and devices
Be familiar with basic cell culture lab techniques such as cell passaging, cryopreservation, formulation of media, aseptic technique using a BSC, cell counting, calculation of reagent quantities
Familiarity with analytical methods used in cell therapy such as ELISA, qPCR, FACS
Self-motivated and willing to accept temporary responsibilities outside of initial job description
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
Technical presentation skills
Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities

How to Apply:

If you are interested in this Process Engineer, Process Design role please click APPLY NOW. For other opportunities available at Adecco Medical and Science go to www.adeccousa.com. If you have questions about the position or would like more information please contact Randy Williamson at 858-812-2601 or by email at randy.williamson@adeccona.com.


  • Apply with Adecco

Reference number US_EN_2_108175_329808