Execute the MSAT strategy including: upstream, downstream, and fill finish production, identifying resource needs and the hiring and management of internal employees, as required
Ensure successful delivery of GMP material, including providing technical oversight of manufacturing batch execution, manufacturing batch close out, and deviation management
Provide immediate campaign support for manufacturing during technical production issues or escalations
Work with the process development and manufacturing teams to provide technical support to Manufacturing to develop platform procedures, batch records, training, and other manufacturing resources as required to prepare for and execute processes
Ensure adherence to GxP guidelines as indicated by phase of manufacture
Assist with the development and drafting study plans and protocols as required to support regulatory requirements, deviations response, process changes, etc.
Develop and maintain structure for process data reviews for internal and external production
Partner with Quality Assurance to ensure on-time creation and lifecycle management of MSAT systems and procedures required for the Quality Management System (technology transfer, comparability, process controls documentation, process performance review, etc.)
B.S., M.S. or Ph.D. in a scientific or engineering discipline and 10+ years of experience for those who have B.S. or M.S. or 8+ years of experience for those who have a Ph.D.
10 or more years of relevant experience in the manufacturing environment
Extensive working knowledge of cGMP systems and FDA/EU regulations
Extensive experience is leading product/process support within a GMP setting leading investigations, technology transfer, process monitoring, process validation, and routine clinical/commercial support
Project management skills, including strategic and tactical projects/tasks, tracking and adhering to budgets, reporting project and campaign metrics, and other project management tools
Experience in functional representation or matrix leadership within a cross-functional team (preferably a CMC team).
Hands-on industrial experience with cell culture, purification, and/or fill finish activities.
Team player and exhibit a willingness to meet project timelines and be a "working manager"
Strong verbal and written skills are required as well as effective interpersonal, technical, and troubleshooting skills
Outstanding planning, organization, and multitasking skills