Process Scientist – Tech Transfer

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Job Description

Cpl in partnership with our client Pfizer are currently recruiting for a Process Scientist for an initial 11 months contract based in their Grange Castle site. The successful caniddate will be responsible to provide process science, manufacturing technology and validation support for the process tech transfer of cell culture processes into the existing Drug Substance facility.
Contact Miki for the full information on email miki.soma@cpl.ie

Key Responsibilities
  • Capture the all aspects of the existing process and equipment at the donor sites to ensure that an equivalent process is started up at Grange Castle
  • Technology Transfer, including Gap Analysis and Process Transfer Risk Assessment
  • Execute requisite process trials to facilitate transfer as required (bioreactor kLa studies, media/buffer make-up & hold, cleaning cycle development, column packing, preservative flush-out, media simulations, etc)
  • Define the Process Definition (Description), including Bills of Materials, Raw Materials and Consumables
  • Develop process validation protocols and lead their execution on the floor in conjunction with Operations. Generate process validation summary reports and associated filing summaries.
  • Ensure the process automation meets the requirements of the process
  • Process input to equipment specification process, including equipment sizing, specification of key components, verification documentation and process instrumentation ranges.
  • Execute water, demonstration and process validation batches
  • Drafting of filing submissions and assist with inspection readiness activities including preparation of playbooks.
  • Liaise with site functions – logistics, planning, QA, QC, Operations, Regulatory Affairs to support the process transfer to GC
  • Lead major process investigations as requested and support the implementation of CAPAs.
  • Provide technical training on process and technology areas as required by the project.
 
Skills & Experience
  • Sc., B.E. or M.Sc./M.Eng. Degree in Biosciences, Chemical Engineering or equivalent subjects
  • 2+years experience working in a cell culture manufacturing process or process development environment.
  • Familiarity with the operation of cell culture and/or purification technology
  • Experience of process and cleaning validation requirements and execution for GMP biological production
  • Knowledge of technology transfer is preferred but not a requirement
  • Demonstrated aptitude for technical learning and problem solving.
  • Strong evidence of problem solving skills
  • Good communication skills
 
Conditions
  • 11 Months Contract Initially through cpl
  • The role may require flexibility to travel to process donating sites in US/Europe and to project meetings away from site.
 
For further information on this opportunity, please contact Miki Soma on miki.soma@cpl.ie .
Apply via LinkedIn

Miki Soma

Principal Consultant +353 1 634 2776 miki.soma@cpl.ie
  • Salary:Negotiable
  • Location:Dublin West
  • Type:Temporary
  • Category:Science
  • Ref.no:JO-2004-449181