Job DescriptionBioPhase Solutions
specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for an Associate Scientist, Biology
to work for a leading Greater Los Angeles area biopharmaceutical company. Responsibilities:
- Active member of the viral vector upstream team would design, plan, and execute laboratory studies to support process development, characterization, or process improvements
- Perform hands on work in an adherent cell stack factories or suspension culture, cell culture expansion, viral vector production as well as process scale up and implementation into GMP clinical production suites.
- Write and review technical documentation
- Participate and influence a cross-functional development team to advance production activities
- Develop manufacturing processes for viral vector products and develop process improvements and efficiencies
- Perform process analysis and trend process performance
- Design and execute process development studies to develop a thorough understanding of operating and performance parameters
- Knowledge of suspension or adherent cell culture formats, scale-up and engineering principles (e.g. growth rates, specific consumption/production rates, bioreactor aspect ratios, power calculations, gas transfer, shear stress)
- Hands on expertise in cell line engineering, attribute selection and cell sorting (FACS) is required with experience in isolating high productivity cell lines.
- Hands on expertise in laboratory cell culture operations such as maintenance and growth of cells in both static and suspension modes. Previous experience in the development of high productivity and suitable vector cell lines is required.
- Demonstrated excellence in viral vector or cell culture process development, process technology transfer, scale translation, and statistical DOE (design of experiments)
- Build, operate, and troubleshoot bench top and pilot scale bioreactors; compile and analyze results
- Experience with the preparation of regulatory filings for US and external markets is desired
- Understanding of GMP manufacturing
- 7+ years of experience with BS degree in Chemical/Biochemical Engineering, Biochemistry, Biology, or a related scientific discipline
- 5+ years of experience with MS degree in Chemical/Biochemical Engineering, Biochemistry, Biology, or a related scientific discipline
- Previous experience with Cell therapy products, viral vector production in both adherent and suspension cell culture systems, transient transfection and/or stable cell lines is desired.
- A previous track record of culture process development experience such as cell passaging, formulation of media, aseptic technique processing, and managing reagents.
- Practical demonstration of hands on process development including use of statistical design of experiments is required. Experience with automation technologies is desired.
- Practical experience of cGMP manufacturing operations and fluency of regulatory regulations is desired
- Ability to work and collaborate in cross functional teams, research, development, manufacturing in a fast pace and dynamic team setting.
Please send resumes to firstname.lastname@example.org and visit our website at www.biophaseinc.com for additional job opportunities!!!