We're looking for a candidate to fill this position in an exciting company.

• Coordinate studies and reports relating to process understandings, system capabilities and equipment performance through partnership with Production, Engineering and Validation.
• Offer subject matter expertise as a reviewer of project plans, technical reports/studies related to process understanding, regulatory submissions and validation protocols
• Effectively communicate with senior leaders, peers, staff and external organizations
• System owner responsibilities for multiple focus areas within the MS&T function (e.g. Process Validation, Technology Transfer, Cell Banking)
• Fostering an environment that encourages innovation with respect to identification, evaluation and implementation of new process technologies, new products, and improvement to existing commercial products
• Leading the development of strong rapport/collaborative relationships with external and internal partners (i.e. MS&T leaders/teams across the enterprise, internal customers, external agencies, and organizations, etc.).
• Provide fast-paced campaign support for manufacturing during technical production issues or escalations
• Work with 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.
• Develop and draft 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
• Annual departmental goal setting & performance management (i.e. 1-1's, mid-year assessments and year-end evaluations)
• Talent Management: development of talent from entry level to lead positions
• Personnel Development: individual development plans centered on behavioral/leadership competencies as well as the development of new skills and understanding for new technologies
• Establishing & maintaining employee/team engagement
• Build a strong working environment that promotes Emergent's core values and progresses our culture in a positive manner

• B.S., M.S. or Ph.D. in a scientific or engineering (chemical/biochemical/bioprocess engg) discipline and 10+ years of industry experience
• Experience in managing scientists/engineers in a fast paced challenging environment
• Familiarity with site strategic planning (i.e. Hoshin)
• Hands-on industrial experience with cell culture, virus culture, harvesting and other upstream and downstream unit operations
• Experience in gene therapy or iral vector manufacturing is a plus
• Extensive working knowledge of cGMP systems and FDA/EU regulations
• Extensive experience in leading product/process support within a GMP manufacturing setting, leading complex troubleshooting investigations, technology transfer, process development, process monitoring, and process validation.
• Familiarity with project management skills, including strategic and tactical projects/tasks, tracking, and adhering to budgets, reporting project and campaign metrics
• Team player and exhibit a willingness to meet project timelines and be a "working manager"
• Strong verbal and written communication skills are required as well as effective interpersonal and influencing skills
• Outstanding planning, organization, and multitasking skills