Job Description
Senior Process Scientist role involves supporting Process Sciences, Manufacturing, CMC Regulatory and QA Departments through in-process control programs for biologics drug substance and formulated drug substance.
Key responsibilities include lifecycle activities of established IPC programs, supporting CMC Regulatory Sciences, facilitating interdepartmental discussions, presenting findings, and collating data.
Requirements include strong communication and organizational skills, logical troubleshooting and problem-solving skills, and contribution to knowledge sharing and process improvement.
Education and experience requirements include 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.
Job Description
- Carry out lifecycle activities of established IPC programs for manufacturing bioprocesses, including impact assessment, change control, and document generation or revision.
- Support CMC Regulatory Sciences in development and writing of responses for technical sections of regulatory documents.
- Facilitate and coordinate interdepartmental discussions in support of Process Sciences validation and IPC activities.
- Present findings, limit setting, and re-evaluation strategies at group, departmental, and interdepartmental meetings as required.
- Collate and analyse data from development studies, process validation and characterization studies, historical process data, investigative findings, and process risk assessments to support established IPC programs.
- Apply statistical process control tools for re-evaluation of established IPC limits and monitoring of the manufacturing process.
- Complete and review IPC documentation associated with batch manufacture.
Requirements
- Strong communication and organizational skills.
- Logical troubleshooting and problem-solving skills.
- Contribution to knowledge sharing and process improvement.
Education and Experience
- BSc/BEng in Life Sciences/Engineering or a related field with 5 years of experience.
- MSc/MEng in Life Sciences/Engineering or a related field with 4 years of experience.
- PhD in Life Sciences/Engineering.