
Process Scientist
1 week ago
The Process Scientist role is a critical position within our organization, responsible for supporting commercial manufacturing and technology transfers to the drug substance manufacturing facility.
This individual will be located at our Grange Castle site, where they will work closely with the Technical Services Lead and other team members to achieve our business objectives.
- Support commercial manufacturing to meet commercial requirements, including investigations, process robustness, and process improvements.
- Scale up processes to the 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.
This position requires a strong understanding of technical transfer, facility fit, equipment sizing, and mass balance generation for clinical and commercial manufacture. The ideal candidate will have a minimum of 3-6 years of process development/late-stage characterization and technical transfer/technical services experience in single-use systems.
The successful candidate will possess:
- 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.
Required Skills and Qualifications:
- Minimum of 3-6 years of process development/late-stage characterization 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.
Benefits:
This role offers a unique opportunity to work in a dynamic and fast-paced environment, with the chance to develop and grow your skills and expertise.
Others:
We are an equal opportunities employer and welcome applications from diverse candidates. If you are a motivated and experienced process scientist looking for a new challenge, please apply now
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