The Technical Services team are seeking an experienced process scientist whose role will focus in supporting commercial manufacturing and technology transfers to the drug substance manufacturing facility. This role will be located at the Pfizer Grange Castle site. The drug substance facility is a manufacturing area specialising in the manufacture of therapeutic drug substances for a range of clinical and commercial products.
This position will report to the Technical Services Lead and will be an integral part of a high performing technical services team whose role will involve:
• Support commercial manufacturing to meet commercial requirements including investigations, process robustness and process improvements.
• Scale up of processes to the manufacturing facility.
• Perform, present and execute facility fits, mass balance generation, equipment sizing, gap assessments and mitigation of operational challenges foreseen to ensure an equivalent process is transferred to Grange Castle
• Provide independent decision making for strategic input into facility and equipment design
• Prepare, review & execute technology transfer protocols, supporting documentation, manufacturing batch records, design of experiments and at scale process trials to deliver an efficient technology transfer
• Author and review responsible sections of regulatory dossiers including health authority query responses
• Partners with the management and technical team to identify best practices, technical transfer efficiencies and optimisations during technical transfer.
• Develops and maintains effective working relationships with other division groups supporting technology transfer, validation and process support.
Requirements:
• Minimum of 3 - 6 years of process development/ late-stage characterisation and technical transfer / technical services experience in single use systems.
• Demonstrated history and in-depth knowledge of technical transfer, facility fit, equipment sizing and mass balance generation for clinical/ commercial manufacture
• Knowledge and experience of process validation strategies, studies and requirements
• Knowledge of regulatory submissions and response of queries from health authorities
• In depth knowledge of cGMP regulatory requirements related to the design and control of drug substance processes
Skills:
• High technical capability, interpret complex data, problem solving and technical learning.
• Promote information sharing and excellent interpersonal skills
• Capability of working in a multi-disciplinary team environment to tight timelines
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