Associate Director, Engineering - Tech Transfer Lead

Merck • Wilson, NC

3d • Hybrid

About The Position

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.

Requirements

• 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.

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.)

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees