
Cell Culture Development Specialist
1 week ago
The technical services team is seeking an experienced process scientist to support commercial manufacturing and technology transfers to the drug substance small and/or large-scale manufacturing facility. This role will be located at a multiproduct manufacturing area specialising in the manufacture of therapeutic proteins derived from mammalian cell culture for a range of clinical and commercial products.
Key Responsibilities:
• 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.
• 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.
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.
• In-depth knowledge of cGMP regulatory requirements related to the design and control of drug substance processes.
• 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.
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