MSD Malaysia
Associate Director, Engineering - Tech Transfer Lead
MSD Malaysia, Wilson, North Carolina, United States, 27893
* 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 Ordinance #J-18808-Ljbffr
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 Ordinance #J-18808-Ljbffr