Posted to MedZilla on 8/19/2017


ProClinical

England, Senior CMC Bioassay Scientist SC_CO_13121-MZ


 
 

ProClinical is working with a leading biologics drug discovery biotech, is currently seeking to hire a Senior CMC Bioassay Scientist on a permanent basis. The incumbent of this role will develop in-house biological assay capabilities in support of outsourced CMC activities.

Job Responsibilities:

  • Develop and optimise cell based biological assay methods, cell lines and reagents for use in GMP product release and stability testing
  • Assess Discovery based bioassay methods for their utility as potency assays for GMP product release and stability testing
  • Manage the transfer of suitable bioassays to third party contract manufacturing organisations
  • Ensure methods are designed to meet current industry and regulatory guidance
  • Evaluate and implement new technologies as required
  • Authoring of relevant sections of regulatory submissions
  • Contribute to on-going MOA assay development within the group
  • Provide support to project teams throughout the product development process

Skills and Requirements:

  • BSc. or equivalent in an in vitro cell based subject
  • Significant relevant experience in bioassay development and validation for use in GMP
  • Experience in therapeutic monoclonal antibody potency assay methods (target binding/agonism, ADCC etc) and associated microplate platforms (luminescence, MSD, spectrophotometric)
  • Line management or matrix team leadership
  • Experienced in regulatory submissions process
  • Tech transfer experience

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Chidozie Orji on +44 207 4400 671 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Please visit our website at www.proclinical.com

 
 


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