Associate Director, Engineering - Tech Transfer Lead

* 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.)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 cooperation in others, using the diverse perspectives of others to generate ideas.
* Well-developed and effective team facilitation and leadership skills; ability to establish inclusive team environments.
* Demonstrated creative conflict resolution and problem-solving skills.
** Los Angeles Residents Only:
** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring…