Job ID: #8989

Senior Scientist, Formulations & Fill Finish

Cambridge, MA
Science Science
GMP Manufacturing

 

Responsibilities of the Senior Scientist, Formulations & Fill Finish:

  • Build and Establish small-scale fill/finish models to identify process parameters that impact DP CQA’s
  • Collaborate with DP and non-clinical and clinical teams to evaluate container closure options to enable low/high doses and different routes of drug product administration
  • Use risk assessment/management tools and apply QbD principles for successful technology and knowledge transfer to internal and external DP manufacturing sites
  • Supporting cross-functional activities and pipeline priorities by working collaboratively across Process Sciences, Analytical Sciences, Internal/External Manufacturing, Quality, and Regulatory groups.
  • Drive and coordinate studies while managing timelines to meet corporate goals. Perform some hands-on laboratory-based work as needed.

 

Requirements of the Senior Scientist, Formulations & Fill Finish:

  • BS/MS with 8+ years directly related experience or PhD with 3+ years of experience with a background in Chemical Engineering, Bioengineering, or related field
  • Experience with cell culture, cell-banking, cell cryopreservation, aseptic fill/finish operations, technology transfer is required
  • Experience with container closure selection, devices, or drug product administration/in-use stability for cell therapy or biologics is desirable; Excellent scientific aptitude allowing formulation of hypothesis, design and execution of experiments, documentation practices, data analysis, and sound scientific conclusions
  • Extensive Knowledge of GMP/ICH/FDA regulations and experience in regulatory filings in the cell therapy or biologics field is required

    Apply for Position
    Upload Resume

    Commonwealth Sciences is a professional recruiting firm specializing in Life Science, Medical Device, and Engineering Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.