Job Description
The Senior Process Scientist supports Process Sciences, Manufacturing, CMC Regulatory and QA Departments through activities and documentation related to implementation and maintenance of in-process control programs for the manufacture of biologics drug substance and formulated drug substance.
A typical day might include, but is not limited to, the following:
1. Carrying out lifecycle activities of established IPC programs for manufacturing bioprocesses including impact assessment both on a site specific and global level, change control, and document generation or revision.
2. Supporting CMC Regulatory Sciences in development and writing of responses for technical sections of regulatory documents.
3. Facilitating and coordinating interdepartmental discussions in support of Process Sciences validation and IPC activities.
4. Presenting findings, limit setting and re-evaluation strategies at group, departmental, and interdepartmental meetings as required.
5. Collating and analysing data from development studies, process validation and characterization studies, historical process data, investigative findings and process risk assessments to support the established IPC programs over the lifetime of the molecule.
6. Applying statistical process control tools for re-evaluation of established IPC limit, and monitoring of the manufacturing process.
7. Completing and reviewing IPC documentation associated with batch manufacture.
This role might be for you if:
1. You have strong communication and organizational skills.
2. You possess logical troubleshooting and problem-solving skills.
3. You contribute to knowledge sharing and process improvement.
To be considered for this opportunity you should have a BSc/BEng in Life Sciences/Engineering or a related field with 5 years of experience or MSc/MEng in Life Sciences/Engineering or a related field with 4 years of experience or PhD in Life Sciences/Engineering. cGMP experience is desirable.
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