Summary: Supports, develops and maintains in-process control (IPC) programs for manufacturing bioprocesses as part of Process Sciences Department.
Essential Duties and Responsibilities may include, but are not limited to, the following:
- Collates and analyzes data from development studies, process validation and characterization studies, historical process data, investigative findings and process risk assessments to develop In-Process Control (IPC) programs.
- Applies statistical process control tools for limit establishment and monitoring of the manufacturing process.
- Contributes to scientific analysis of results generated from laboratory-scale, and manufacturing-scale studies, including determination of possible mechanisms of process behavior in cell culture and/or purification systems.
- Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer.
- Participates in process and quality risk assessments.
- Presents findings, limit setting strategies, and process monitoring data at group, departmental, and interdepartmental meetings as necessary.
- Assists in troubleshooting activities associated with the manufacturing process.
- Supports technology transfer activities as needed.
- Support CMC Regulatory Sciences in developing and writing of responses for technical sections of regulatory documents.
- Presents findings at group and interdepartmental meetings.
Education and Experience:
- PhD in Biotechnology, Biochemistry or a related field with 0-2 years’ experience; or MSc in Biotechnology, Biochemistry or a related field with 4+ year’s relevant experience; may consider another discipline with added relevant experience. cGMP experience is desirable.
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