Job Description
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.