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Process Scientist, TechnologyTransfer

Job Title: Process Scientist, TechnologyTransfer
Contract Type: Permanent
Location: Kildare
Industry:
REF: 123684
Contact Name: Director of The RFT Group
Contact Email: gerry@rftgroup.ie
Job Published: about 2 months ago

Job Description

Process Scientist, Tech Transfer Cutting edge innovation West Dublin

Our client is a multinational biopharmaceutical company with an outstanding track record of innovation in their specialist therapeutic sector: cell engineering technology. This newly created West Dublin based role requires experience in biologic based technology transfer for a highly rewarding permanent appointment.

Role overview
This role reports to the Senior Director of Technical operations. The successful candidate will be a key member of the technical transfer team, working within the Process Development team supporting the multiple transfers of company technology to external parties
Job Spec
  • Responsibility for the technology transfer of the process into selected facilities including representing site at key tech transfer meetings with the clients and partner companies.
  • Provide process science, manufacturing technology and validation support for the process tech transfer of their product processes, internally and externally.
  • Provide independent decision making for strategic input into the facility & equipment design, support site operational readiness (equipment, process understanding etc.).
  • The role will require flexibility to travel to sites in Canada/US/Europe and to project meetings away from site.
  • Capture all aspects of the existing process and equipment at the sites to ensure that an equivalent process is started up.
  • Technology Transfer, including Gap Analysis and Process Transfer Risk Assessment.
  • Execute requisite process trials to facilitate transfer as required
  • 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.
  • Support the Process development team with the execution of demonstration and process validation batches.
  • Drafting of filing submissions and assist with inspection readiness activities including preparation of process batch records etc.
  • Liaise with site functions –Operations, Project Management, Engineering, Process Development to support the process transfer.
  • 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.

Person Spec
  • BSc is a minimum M.Sc/Ph.D
  • 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 required.
  • Excellent interpersonal skills and good ability to multitask.
  • Strong communication skills, both verbal and written.
  • Can work both independently and as part of a dynamic team.
  • An enthusiastic ambitious positive self-starter.
  • Highly motivated with an ability to take ownership and with strong attention to detail.
  • Ability to work under pressure.
Cv to gerry@rftgroup.ie