Strategic Planning: Defines strategy for the product franchise by representing Drug Product on product strategy teams and leads a cross-functional technical team that creates and governs the Drug Product technical project portfolio for the designated product. Technical Oversight: Collaborate with process development and analytical development to ensure early pipeline assets have a robust process. Key Deliverables: Primary owner of the Drug Product process for the designated product. Technical content and strategy across tech transfers, process validation, technical reports, data analysis, process monitoring, change control and implementation, product comparability and escalated support of technical/scientific process and analytical issues Regulatory & Documentation: Provide technical content for documents such as PPQ protocol or comparability assessments, author content for regulatory submissions and annual product quality review, present technical strategies during major health authority interactions and inspections. Cross Functional Leadership: Collaborates closely with analytical, quality, regulatory, operations, development, supply chain, strategy, third party manufacturing and manufacturing sciences roles to drive the brand strategy and prevent supply disruptions. Lead efforts focusing on alignment and harmonization of manufacturing process across multiple sites. Oversees implementation of lifecycle management projects and responsible for gaining consensus on change implementation strategies that ensure robust Drug Product supply. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. B.S/MS/PhD in Chemical Engineering or Biology, Chemistry, Biochemical (Life Science) with 12+ years of relevant experience in the biopharmaceutical company with most of that experience demonstrating progression of technical leadership responsibilities and scope. Previous experience should be a combination of technical operation functions such as manufacturing, quality, MS&T (Technical operations) or Technical Development. Should have excellent communication skills and be able to strategically influence the direction of the company in the scope areas mentioned above. Experience should include technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for Drug Product manufacturing and processing equipment, manufacturing support and technology transfer. Ability to define the right processes for the team's maturity level, balancing agility and discipline. Prior experience in leading cGMP investigations utilizing formal Root Cause Analysis tools strongly preferred. Ability to assess risk and develop contingency plans for process risks. Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities. Detail oriented with excellent verbal and written communication skills. Strong interpersonal and leadership skills to work with teams in different functions and organizations. Experience leading regulatory inspections regarding tech transfer, validation and extensive knowledge of regulations, current industry practices. Should have demonstrated the skill to lead large, complex technical organizations with a global scope and build processes, and technology in a growing organization. Proven project management skills (organization, collaboration, multi-tasking, and communication), attention to detail, and the ability to perform well in a team-based environment are required Additional preferred qualifications: 2-3 years of experience in cell therapy process development and or manufacturing. Combination of experience in process development, MS&T and quality, experience with manufacturing automation systems/platform. This position will require up to 20% travel.