Job ID: #8198

Senior Manager, CMC Manufacturing

Cambridge, MA
Science Science
GMP Manufacturing

 

Responsibilities of the Senior Manager, CMC Manufacturing:

  • Manage CMOs on cell-line development, process and formulation development, analytical development, scale-up, quality control and validation of mAbs.
  • As subject matter expert, work with CMOs, to generate technical protocols, development reports, and batch records for the cGMP manufacture of mAb drug substance and drug product to support early-stage clinical studies.
  • Closely work with internal team members of cross-functional teams to reach project milestones and support integrated timelines
  • Write and/or review documentation used for regulatory submissions

Requirements of the Senior Manager, CMC Manufacturing:

  • BS/MS in biology/biologics, chemical engineering or equivalent
  • Minimum 8 years of experience in development and/or relevant industry experience in the manufacture of biologics
  • cGMP manufacturing experience and/or thorough understanding of cGMPs, as well as US and ICH Quality guidance required
  • Strong technical aptitude including demonstrated experience of developing and
  • supporting the life-cycle management of biological processes

 

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green 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.

Commonwealth Sciences, Inc.

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Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green 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.