Website Goodwin Biotechnology

Scope of Function:   Manager of the Upstream Manufacturing group of our rapidly growing team. In this important position, you will build and manage a team to execute CHO based cell culture processes following GMP guidance, generating clarified Harvested Cell Culture Fluid (HCCF) to be used for further manufacturing by the Downstream manufacturing team. This role will also include a close working relationship with the Process Development team to perform technology transfer to support GMP level manufacturing and work cross functionally with support groups such as Quality Assurance, Quality Control and Materials Management.  These efforts are all focused to help advance novel therapies for Goodwin’s clients.

Reports to:  Associate Vice President of Manufacturing

 

Specific Duties:

  • Manage activities of the Upstream Manufacturing group to provide expertise and support for GMP manufacturing operations
  • Monitor manufacturing activities needed for the specific projects, review results to provide real-time updates to clients
  • Collaborate in the technology transfer of cell culture processes from the development group into manufacturing
  • Responsible for scheduling the maintenance of process equipment around the production schedule in collaboration with Facilities
  • Write, review, revise, and prepare clear and concise Standard Operating Procedures (SOPs), MBR, Production Documents and other relevant documentation necessary to facilitate efficient GMP operation in collaboration with Manufacturing, Facilities and QA
  • Perform timely production reviews on completed GMP documentation
  • Hire, train and develop an effective upstream operations team that will use both SS and SUB bioreactors at 200L and 500L scale
  • Manage and evaluate direct reports performance
  • Drive process improvement and metric progress in key areas of responsibility: Safety, Quality, Delivery, Economics (cost-effectiveness), and People
  • Work with Client Services Project Manager to interact with clients providing timely update of the projects as needed
  • Experience with operating benchtop bioreactors, pilot scale bioreactors
  • Experience with cell expansion in shake flasks, spinner flasks and T-flasks
  • Enhance cell culture process understanding and participate in platform optimization efforts

Education, Experience, and Skills Required:

  • BA/BS or MS in engineering or biological science or related field
  • A minimum of 5 years experience in cGMP biologics manufacturing
  • Candidate must have detailed hands-on experience with large scale GMP cell culture, bioreactor and buffer formulation;  suspension and adherent cell culture experience is preferred
  • Experience in biologics manufacturing, Phase I-III clinical manufacturing and/or commercial manufacturing is essential

Interacts with:

  • This position interacts with Process Development, GMP manufacturing (USP and DSP), Facilities, Project Management, Quality Control, and Quality Assurance departments