General Research & (Clinical) Development Expert 1 Apply
This position is responsible for supporting efforts to generate process transfer documentation as a member of the Tech Transfer team within Technical Operations. The successful candidate will work cross-functionally with the Manufacturing and Quality teams to produce standardized, robust cGMP documentation and support projects to improve the cycle time for moving process documents from development into production.
Responsible for activities including:
• Produce high-quality process documentation under the guidance of Tech Transfer scientific staff, including batch records, item specifications, forms, SOPs, and bills of material (BOMs)
• Collaborate with Manufacturing and Quality departments to align on best practices and conventions for process transfer documentation and provide continuous guidance to Tech Transfer team to achieve standardization of format and content
• Support efforts to train Manufacturing staff and produce training materials under the guidance of a Tech Transfer project lead
• Assist with internal projects to improve the overall cycle time for process documentation transfer into Manufacturing
• Provide additional support and cross-train as business needs arise
