Process Scientist

Background:
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.

Requirements:

• 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

How to apply

• Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you!

Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
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Disability Inclusion
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Engineering