Technical Process Scientist
4 days ago
About the Job
We are seeking a seasoned process professional to join our technical services team in a key role that will drive commercial manufacturing and technology transfers to our drug substance manufacturing facility.
This position reports to the Technical Services Lead and is an integral part of a high-performing technical services team whose responsibilities include:
- Supporting commercial manufacturing to meet commercial requirements, including investigations, process robustness, and process improvements.
- Scaling up processes to the manufacturing facility.
- Performing, presenting, and executing facility fits, mass balance generation, equipment sizing, gap assessments, and mitigation of operational challenges foreseen to ensure an equivalent process is transferred.
- Providing independent decision-making for strategic input into facility and equipment design.
- Preparing, reviewing, and executing technology transfer protocols, supporting documentation, manufacturing batch records, design of experiments, and at-scale process trials to deliver an efficient technology transfer.
- Authoring and reviewing responsible sections of regulatory dossiers, including health authority query responses.
- Partnering with the management and technical team to identify best practices, technical transfer efficiencies, and optimisations during technical transfer.
- Developing and maintaining effective working relationships with other division groups supporting technology transfer, validation, and process support.
Key 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.
- 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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