
Chief Process Specialist
1 day ago
Job Title: Chief Process Specialist
Job Responsibilities:- The role involves leading the efficient transfer of customer production processes to a manufacturing facility, ensuring timely and successful execution.
- Collaboration is key in this position, working with cross-functional teams including technical experts from customers or donor sites, Manufacturing, Quality Assurance, Quality Control, and other departments to facilitate technology transfer.
Responsibilities include:
- Process Support: Prepare, execute, monitor, and post-campaign activities for cell culture or purification stages of customer production processes at the manufacturing facility.
- Monitoring process behavior, identifying issues, and developing problem-solving skills to generalize across processes.
- Investigating process trends, issues, or deviations involving multiple departments and customers, writing change requests, and driving implementation.
- Providing technical input on manufacturing batch records and supporting MFG document writing specialists.
- Supporting plant start-up and pilot/commercial runs, performing technical investigations, and assisting in authoring technical reports.
- Maintaining process databases and monitoring batch-to-batch consistency of operations.
Key Skills and Experience:
- Over 5+ years of experience in biotechnology process development, process support, research, or a related manufacturing environment.
- A graduate degree in Chemical engineering, biochemical engineering, biochemistry/chemistry/biological science, or a related field.
- Prior experience in technology transfer within the purification or cell culture domain.
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