Associate Director, Engineering - Tech Transfer Lead

Job Description

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. 

The incumbent will have broad, experience-based skillsets in Technology Transfers with key focus on standards, technical robustness, and right first-time success for commercial scale device assembly and packaging technology and components.  Experience also includes strong project management skills and utilization of program/portfolio management tools with demonstrated experience working with internal and external partners and stakeholders and influencing technical strategy.

Key Responsibilities:

• Leading TT, Ensuring On-time Delivery: Manages and 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 problem 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.)

Minimum Education Requirements and Experience:

• 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.

Required Skills and Experience:

• 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, wi