Cpl in partnership with our client Pfizer are seeking a Scientist - Technical Services to join the team for an 11 month fixed term contract at their state of the art site in Dublin, Grange Castle. This role has a hybrid working model attached.
The technical services team are seeking an experienced scientist whose role will focus on supporting upstream commercial manufacturing and technology transfers to the small scale facility (SSF) manufacturing facility. This role will be located at the Pfizer Grange Castle site. The SSF 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 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 from bench and pilot scale and support technology transfers to the 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 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, technology transfer efficiencies and optimisations during transfer.
- Develops and maintains effective working relationships with other division groups supporting technology transfers, validation and process support.
Requirements:
- Minimum of 2 - 6 years of mammalian cell culture and/ or purification process development/ late-stage characterisation and technology transfer/ technical services experience in stainless steel and/or single use facilities
- Demonstrated history and in-depth knowledge of cell culture and/ or purification scale up practices, technology 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.