Associate Director, Engineering - Tech Transfer Lead

Associate Director, Engineering - Tech Transfer Lead

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We are seeking a highly motivated individual for the role of Associate Director, Tech Transfer Leader supporting the Wilson Packaging Technical Operations Team. This role will drive end-to-end technical readiness for new product introduction and technology transfer at the site, including management of all activities required for the technical transfer of new and in-line products and processes.

• Leading TT, Ensuring On-time Delivery: manages and is accountable for the overall technology transfer activities with end-to-end visibility to site deliverables for the device assembly and packaging process, analytical and facility readiness.
• Partners with above-site Development and Commercialization teams on overall TT strategy and TT plan.
• Single TT point of contact interfacing with the Development and Commercialization Teams, Packaging and Device Working Groups, VCMTs.
• Ensure clear communication within Science & Technology, Wilson, and with leaders/stakeholders regarding technical / execution risks and progress vs. project plan.
• Develop and manage integrated project plan and lead the end-to-end (incoming, manufacturing, release) readiness for new and in-line product introductions and Tech Transfer into the site with strong direct and indirect leadership and influencing skills.
• Use Subject Matter Expertise with broad packaging and combination product experience (process, device assembly/packaging, equipment, components) in Tech Transfer / New Product Introduction to pressure test site readiness robustness through proactive risk assessment (technical and execution risks). Able to identify risks across functional areas/interfaces and develop robust mitigation actions. Able to operate effectively in face of ambiguity, supporting scenario planning and options analysis to support risk-based decision making.
• Use Demonstrated end-to-end assembly and packaging operations technical breadth, including solving to lead technical team accountable for rigorous technical outcomes including process qualification and validation, component qualification, specifications, artwork profiles.
• With the site team, develop/set strategy for the launches. Once in execution, transfer to run the business (Supply chain).
• Schedule and facilitate technical reviews associated with tech transfer.
• Accountable for After Action Reviews and knowledge sharing with other TT teams.
• Required to comply with our Company Global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Work collaboratively to drive a safe and compliant culture.
• Builds strong cross-divisional partnerships with site leaders, functional management, and other stakeholders (Research & Development, Commercialization, Tech Ops, Ops, Quality, Analytical Regulatory-CMC, and Supply Chain, etc.).

• Bachelor of Science (B.S.) in Engineering, or related field with seven (7) years of combination experience in relevant Device assembly/packaging, project management, and (cross-functional) leadership. OR
• Master of Science (M.S.) in Engineering or related field with five (5) years of combination experience in relevant Device assembly/packaging, project management, and (cross-functional) leadership.

• Extensive technical knowledge and experience in device assembly and packaging processes for a diverse range of images (including vials, syringes, cartridges, autoinjectors, inhalers, bottles, and blisters). Proficient in facility, equipment, and operational controls for BSL and OEB 4/5 products.
• Demonstrated technical expertise in product commercialization and lifecycle management across multiple platforms and modalities, with a focus on overseeing technology transfer from a site perspective.
• Proficiency with change control and deviation management.
• Strong knowledge of global regulatory guidelines and cGMP principles.
• Demonstrated ability to create and analyze detailed, cross-functional project plans (including Gantt charting) and manage execution and change against those plans.
• Manages effectively with diverse teams (cross-functionally, cross-culturally, and across internal / external sites) to align and drive TT results.
• Effective verbal and written communicator who keeps stakeholders / partners apprised of plans, status, and issues.
• Works well in ambiguity.
• Able to articulate TT to others.
• Establishes clear goals, delegates effectively, holds self and others accountable.
• Flexible and adaptable to dynamic situations.
• Cross-functional team management; successful at indirect management.
• Ability to succeed in a dynamic environment with flexibility to respond to changing priorities.
• Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster…