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Merck · 3 hours ago

Associate Director, Engineering - Tech Transfer Lead

USA - North Carolina - Wilson

Full-time

Hybrid

Lead/Staff, Director/Executive

$129K/yr - $203K/yr

5+ years exp

Merck is a leading global healthcare company, and they are seeking an Associate Director, Engineering - Tech Transfer Lead to support their Wilson Packaging Technical Operations Team. This role involves driving technical readiness for new product introduction and technology transfer, managing all activities required for the technical transfer of products and processes, and collaborating with various teams to ensure successful execution.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

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.)

Qualification

Technology TransferDevice AssemblyManufacturing Practices (GMP)Project ManagementPackaging EngineeringProcess OptimizationCross-Functional TeamworkMedical Device AssemblyNew Product Introduction ProcessManufacturing Scale-UpCompliance PackagingLeadershipTechnical Leadership

Required

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

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