Job description: The technical services team are seeking an experienced process scientist whose role will focus on supporting commercial manufacturing and technology transfers to the drug substance small and/or large-scale manufacturing facility.
This role will be located at the Pfizer Grange Castle site.
The drug substance facility is a multiproduct manufacturing area specialising in the manufacture of therapeutic proteins derived from mammalian cell culture for a range of clinical and commercial products.
This position will report to the drug substance 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 mammalian cell culture processes from bench and pilot scale to a pilot & large-scale 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, 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.
Required profile: Minimum of 3 - 6 years of mammalian cell culture process development/ late-stage characterisation and technical transfer / technical services experience in stainless steel and/or single use facilities Demonstrated history and in-depth knowledge of cell culture scale up practices, 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 Effective communication, planning and organisation skills to deliver documentation.
Work Location Assignment: Hybrid Additional Information In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.
Please note there is no relocation support available for this position Skills: mammalian cell cell culture scientist