Associate Director, Engineering

Overview We are hiring an Associate Director, Engineering within Biologics External Manufacturing Technology. The role serves as the key technical leader interfacing with external partners to manage technology transfers, commercial supply, and partner integration. The position is based in the United States on the West Coast, reporting to the Director of Biologics External Manufacturing Technology. Responsibilities Serve as a single point of technical contact for assigned external partners, impacted manufacturing sites, and commercialization teams. Provide technical oversight, management, and planning support for complex partnership models, coordinating communications and oversight of technical issues. Be accountable for overall technology transfer delivery on time and within budget, working with operations leadership to secure necessary resources. Offer technical guidance to external partners, assess viability of technologies, verify adherence to standards, and ensure deliverables are technically sound. Collaborate with procurement, operations, quality, regulatory, and other stakeholders to evaluate external partners for inclusion and conduct due‑diligence assessments. Ensure technology transfers are positioned for successful business outcomes, including execution of transfers and site readiness activities. Lead the identification and assessment of partner risks and develop mitigation plans. Develop and execute validation strategies for new and existing products. Provide manufacturing process support to external partners to resolve production issues and optimize capacity. Maintain targeted communications and alignment across technical functions, guiding and coaching others in change leadership. Coordinate complex investigations with interfaces to other impacted manufacturing sites. Determine resource plans across relevant technical functions. Review external partner process change requests, deviations, and master batch record changes, minimizing duplication of efforts. Drive and support continuous process verification and performance monitoring programs for all products under responsibility. Ensure external partners are inspection‑ready for new product introductions and transfers, working with commercialization, quality, and regulatory teams. Partner with operations and quality to develop efficient ways to meet regulatory requirements. Collaborate with external partners to achieve business goals and establish a common culture benefiting both parties. Qualifications Bachelor’s degree in engineering or applicable science is required; an advanced degree in engineering, science, or business is preferred. Minimum of 8 years post‑bachelor’s experience in drug substance and/or drug product vaccines and/or biologics manufacturing, engineering, or technical support of operations. Proven expertise and accomplishments in leading technical transfers. Experience leading cross‑functional teams supporting manufacturing operations at internal sites or external partners. Expertise in lean manufacturing applications for productivity improvements. Advanced problem‑solving skills and experience leading teams to resolve complex business or technical issues. Excellent leadership, collaboration, change management, interpersonal, and analytical skills with strong communication abilities. Ability to motivate a team around a common vision and deliver expected results. Creative, innovative thinker with solid engineering fundamentals and process troubleshooting skills. Experience in complex international environments with matrix organization structures. Experience in large molecule unit‑operation design, startup, or operation. Skills Adaptability, automation systems, capital project management, change management, clinical manufacturing, data analysis, decision making, drug product manufacturing, interpersonal relationships, lean manufacturing, manufacturing scale‑up, regulatory compliance, root cause analysis (RCA), strategic thinking, technical transfer. Travel Requirements Travel of up to 50% of the time for partner assignments outside the primary location, primarily within the designated EU region. Location Position may be based in Northern California or other U.S. sites. US and Puerto Rico residents only. San Francisco residents and Los Angeles residents are encouraged to apply. Reporting Structure Reports to the Director, Biologics External Manufacturing Technology. Salary USD 142,400 – 224,100 per year. Additional compensation may include annual bonuses and long‑term incentives where applicable. Benefits Medical, dental, vision, and other health insurance for employees and families; retirement benefits including 401(k); paid holidays, vacation, and sick days; other benefits as detailed in the company compensation portal. EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. #J-18808-Ljbffr Merck & Co.