Website Goodwin Biotechnology

Scope of Function:

Responsible for technology transfer, manufacturing support and evaluation of new technologies relative to upstream process development.

1) The transfer of existing Upstream Cell culture processes from client companies into process development and facilitating their transition into GMP production.

2) The design, development and scale up of new cGMP compliant mammalian cell culture and other upstream processes.  These processes will consist of perfusion and stirred tank culture methods.

3) The resolution of technical problems and the monitoring of ongoing manufacturing campaigns.

Reports to:  Head of MSAT

 

Specific Duties: 

  • Actively participate in tech transfer and process development activities
  • Perform complex DOE experiments using shake flasks and small-scale bioreactors
  • Generate and review documentation supporting technology transfer
  • Define success criteria for technical transfer and provide expert evaluation of the technical outcomes
  • Identify and lead continuous improvement opportunities relating to the manufacturing process
  • Write complex technical reports to a high standard
  • Development of bioreactor manufacturing processes utilizing mammalian cell expression systems that meet GMP manufacturing requirements
  • Development of batch or fed-batch cell culture processes
  • Development of perfusion cell culture processes using various types of cell retention technologies
  • Development of stirred tank cell culture processes
  • Media development and optimization studies
  • Introduction of new processes and technologies into cGMP manufacturing
  • Interaction with clients to facilitate the transfer of technical information between GBI and the client organization
  • Good understanding of regulatory compliance and guidelines (e.g. FDA, EMEA, and ICH)
  • Development, planning and execution of pre-GMP scaled process runs/toxicology material
  • Establish Bill of Materials list for new processes and maintenance of laboratory inventories and equipment
  • Manage Process development scientists and Laboratory schedules to account for priority changes and project status. Interact with PD downstream to consolidate schedules
  • Record process development activities and results in appropriate notebooks
  • Technology transfer of upstream processes into production and the training of production personnel. Coordination of activities and communication to assure efficient transfer of projects to manufacturing
  • Writing and executing design input protocols and design output reports
  • Writing SOPs and Batch records for newly implemented manufacturing processes
  • Good verbal and written skills to communicate project status with clients and Project Management as needed
  • Demonstration of ability to multi-task projects
  • Interfacing with Sales and Marketing directly with perspective clients in order to facilitate sales

 

Education:

  •  Bachelor’s or Master or Ph.D. in Chemical/Biochemical Engineering, Biochemistry

Experience:

  • 3-5 years of experience Engineering, Biochemistry or a related field
  • Experience running 5L to 50L bioreactors using fed batch or perfusion process essential
  • Process development or cell line development experience required
  • Experience in technology transfer within the GMP environment preferred
  • Expertise in the use / application of variety of problem solving tools and quality risk assessment methodologies would be ideal
  • Understanding of theoretical and practical challenges of scale-up would be beneficial
  • Experience with statistical software such as JMP preferred

Interacts With: 

  • Upstream Manufacturing, Protein Characterization, Process Development – Downstream, and Project Management