Associate Director (Engineering), Biologics External Manufacturing Technical Operations
Merck
August 20, 2026
On-site
West Point, PA
Operations
Responsibilities:
- Serve as single technical point of contact for External Partners, impacted Manufacturing sites, and Commercialization.
- Provide technical oversight, management, and planning for complex partnership models.
- Lead tech transfer delivery (on-time, within budget); ensure resourcing with Operations leadership.
- Guide External Partners: assess technology viability/configurations, verify standards adherence, ensure technically sound deliverables.
- Coordinate external partner evaluation and technical due diligence with Procurement, External Manufacturing Operations, External Quality, Regulatory, and others.
- Execute tech transfers and receiving site readiness activities for successful business outcomes.
- Lead partner risk identification/assessment and mitigation planning.
- Develop and execute validation strategies; provide manufacturing process support to resolve issues and optimize process/capacity.
- Drive alignment/communications across technical functions; coach change leadership.
- Support/coordinate complex investigations across manufacturing sites.
- Review partner process changes, deviations, and Master Batch Record changes; minimize duplication between partner and company systems.
- Drive continuous process verification and performance monitoring; ensure inspection readiness for new introductions/transfers.
- Collaborate to meet regulatory requirements efficiently and build a shared partner culture.
Qualifications:
Required:
- Bachelor’s degree in Engineering, Science, or Business.
- 8+ years post-bachelor’s in vaccines/biologics Drug Substance and/or Drug Product manufacturing, engineering, and/or technical ops support.
- Demonstrated expertise leading technical transfers.
- Advanced problem-solving; experience leading teams for complex business/technical issues.
- Strong leadership, collaboration, change management, interpersonal, analytical, and written/verbal communication skills.
Preferred:
- Advanced degree.
- Cross-functional leadership experience (internal sites or External Partners).
- Lean Manufacturing experience for productivity improvements.
- Experience in complex international matrix environments; Large Molecule unit operation design/startup/operation.
Travel: ~30% partner assignments (primarily within US region).
Salary/bonus/benefits: Annual bonus and long-term incentive (if applicable); comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, sick/compassionate days).
Application: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Job posting end date: 09/04/2026. Requisition ID: R412927.
- Serve as single technical point of contact for External Partners, impacted Manufacturing sites, and Commercialization.
- Provide technical oversight, management, and planning for complex partnership models.
- Lead tech transfer delivery (on-time, within budget); ensure resourcing with Operations leadership.
- Guide External Partners: assess technology viability/configurations, verify standards adherence, ensure technically sound deliverables.
- Coordinate external partner evaluation and technical due diligence with Procurement, External Manufacturing Operations, External Quality, Regulatory, and others.
- Execute tech transfers and receiving site readiness activities for successful business outcomes.
- Lead partner risk identification/assessment and mitigation planning.
- Develop and execute validation strategies; provide manufacturing process support to resolve issues and optimize process/capacity.
- Drive alignment/communications across technical functions; coach change leadership.
- Support/coordinate complex investigations across manufacturing sites.
- Review partner process changes, deviations, and Master Batch Record changes; minimize duplication between partner and company systems.
- Drive continuous process verification and performance monitoring; ensure inspection readiness for new introductions/transfers.
- Collaborate to meet regulatory requirements efficiently and build a shared partner culture.
Qualifications:
Required:
- Bachelor’s degree in Engineering, Science, or Business.
- 8+ years post-bachelor’s in vaccines/biologics Drug Substance and/or Drug Product manufacturing, engineering, and/or technical ops support.
- Demonstrated expertise leading technical transfers.
- Advanced problem-solving; experience leading teams for complex business/technical issues.
- Strong leadership, collaboration, change management, interpersonal, analytical, and written/verbal communication skills.
Preferred:
- Advanced degree.
- Cross-functional leadership experience (internal sites or External Partners).
- Lean Manufacturing experience for productivity improvements.
- Experience in complex international matrix environments; Large Molecule unit operation design/startup/operation.
Travel: ~30% partner assignments (primarily within US region).
Salary/bonus/benefits: Annual bonus and long-term incentive (if applicable); comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, sick/compassionate days).
Application: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Job posting end date: 09/04/2026. Requisition ID: R412927.