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Senior Process Integration Specialist
2 weeks ago
Senior Process Integration Specialist
Job SummaryWe are seeking an experienced professional to execute the transfer requirements of late-stage clinical and/or PPQ programs.
The ideal candidate will have:
- Collaborate with stakeholders to ensure seamless integration of new processes.
- Coordinate meetings with local and international groups to implement new Drug Substance processes.
- Manage program schedules to ensure timely execution and right-first-time delivery.
- Deliver GMP documents related to TT, such as Risk assessments, change controls, batch records, sampling plans, Bills of Material.
- Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes.
The successful candidate will possess:
- A minimum of 3 years of work experience in the pharmaceutical or biotech industry.
- Bachelor's degree in Engineering, Biotechnology, Chemistry, or related field.
- Technical knowledge with Biologics drug substance upstream and downstream operations or process development.
- Understanding of New Product Introduction NPI/Tech Transfer principles and activities.
This role offers a competitive salary range. Interested candidates should submit their application for further information and consideration.