Scientist II, Formulation

Sangamo BioSciences   •  

Richmond, CA

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 195 days ago

This job is no longer available.

JOB SUMMARY:   

Sangamo Therapeutics is seeking a highly motivated individual with formulation process development experience to contribute to the development of best in class viral vector and cell therapy drug product manufacturing processes. As a process development scientist you will be responsible for the development of drug product formulations, including developing assays that predict stability, and optimization of drug product manufacturing processes.  You will be expected to contribute new ideas and innovative solutions to technical challenges.  The formulation scientist will define critical process parameters, perform product characterization studies, and provide draft documentation to support regulatory filings  

ESSENTIAL FUNCTIONS: 

  • Design and implement robust, scalable formulations for viral vector and cell therapy products
  • Develop and implement biochemical and biophysical characterization methods to support formulation and stability studies
  • Perform design of experiment approaches to optimize  formulations for AAV, Stem Cells, and T Cell products
  • Responsible for the design and performance of drug product biocompatibility studies, including issuance of development reports supporting regulatory filings
  • Excellent analytical and communication skills, and proven ability to work effectively in a matrix organization to meet team objectives
  • Contribute to the compilation and review of master production records, standard operating procedures, development/validation protocols and reports
  • Work effectively with Analytical Method Development, Down Stream Process Development, Research, Pre-Clinical Development, and Quality teams, to ensure the successful achievement of company timelines and milestones  

  EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

  • Ph.D. in biochemistry, pharmaceutical sciences, biochemical engineering, or related discipline and a minimum of 4+ years process development experience in industry or (BS/MS) with 8 + years of experience
  • Experience working with viral and or cell therapy products
  • Proficiency with applying chromatographic (HPLC, UPLC, column chromatography) methods, capillary electrophoresis and biophysical techniques (UV-vis, DLS, CD, FTIR, DSC, AUC, Fluorescence, particle analysis, etc.) for product characterization
  • Experience in QbD methodologies and statistical analysis using JMP or Minitab
  • Excellent oral and written communication skills are required
  • Enthusiasm in science with a motivation for making contributions in a team environment is necessary.

  OTHER REQUIREMENTS:

  • Previous experience with viral vectors and /or cell therapy products is a plus
  • Experience in IND and Pivotal drug product programs is desirable