Associate Director (Engineering), Biologics External Manufacturing Technical Operations
Merck
August 20, 2026
Remote friendly (Rahway, NJ)
United States
Operations
Responsibilities:
- Serve as the single point of technical contact to assigned External Partners, impacted manufacturing sites, and Commercialization.
- Provide technical oversight, management, and planning support for complex partnership models.
- Own overall tech transfer delivery (on-time, within budget) with Operations Unit leadership to ensure resourcing.
- Provide technical guidance to External Partners; assess technology viability in proposed configurations; verify adherence to standards; ensure deliverables are technically sound.
- Collaborate with Procurement, External Manufacturing Operations, External Quality, Regulatory, and others to evaluate External Partners for inclusion; execute technical due diligence.
- Position tech transfers for business success; execute technical transfers and receiving site readiness.
- Lead assessment of partner risks and develop mitigation plans.
- Develop and execute validation strategies for new and existing products.
- Support External Partners with manufacturing process issue resolution and process/capacity optimization guidance.
- Drive communications and alignment across technical functions; coach change leadership.
- Support/coordinate/manage complex investigations with relevant site interfaces.
- Determine resource plans across technical functions.
- Review External Partner process change requests, deviations, and Master Batch Record changes; minimize duplication between partner and company systems.
- Drive continuous process verification and process performance monitoring.
- Ensure External Partners are inspection-ready for new introductions and transfers.
- Partner with Operations, Quality, and External Partners to meet regulatory requirements more efficiently.
- Collaborate to achieve business goals and build a shared culture.
Qualifications:
Required:
- Bachelor’s degree in Engineering, Science, or Business.
- 8+ years post-bachelor’s experience in vaccines/biologics drug substance and/or drug product manufacturing, engineering, and/or technical support.
- Demonstrated leadership in 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 in Engineering, Science, or Business.
- Experience leading cross-functional teams for manufacturing operations (internal or External Partners).
- Lean Manufacturing experience for year-on-year productivity improvements.
- Matrix/international experience; Large Molecule unit operation design/startup/operations.
Application:
- Apply at https://jobs.merck.com/us/en. Application deadline is stated on the posting.
- Serve as the single point of technical contact to assigned External Partners, impacted manufacturing sites, and Commercialization.
- Provide technical oversight, management, and planning support for complex partnership models.
- Own overall tech transfer delivery (on-time, within budget) with Operations Unit leadership to ensure resourcing.
- Provide technical guidance to External Partners; assess technology viability in proposed configurations; verify adherence to standards; ensure deliverables are technically sound.
- Collaborate with Procurement, External Manufacturing Operations, External Quality, Regulatory, and others to evaluate External Partners for inclusion; execute technical due diligence.
- Position tech transfers for business success; execute technical transfers and receiving site readiness.
- Lead assessment of partner risks and develop mitigation plans.
- Develop and execute validation strategies for new and existing products.
- Support External Partners with manufacturing process issue resolution and process/capacity optimization guidance.
- Drive communications and alignment across technical functions; coach change leadership.
- Support/coordinate/manage complex investigations with relevant site interfaces.
- Determine resource plans across technical functions.
- Review External Partner process change requests, deviations, and Master Batch Record changes; minimize duplication between partner and company systems.
- Drive continuous process verification and process performance monitoring.
- Ensure External Partners are inspection-ready for new introductions and transfers.
- Partner with Operations, Quality, and External Partners to meet regulatory requirements more efficiently.
- Collaborate to achieve business goals and build a shared culture.
Qualifications:
Required:
- Bachelor’s degree in Engineering, Science, or Business.
- 8+ years post-bachelor’s experience in vaccines/biologics drug substance and/or drug product manufacturing, engineering, and/or technical support.
- Demonstrated leadership in 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 in Engineering, Science, or Business.
- Experience leading cross-functional teams for manufacturing operations (internal or External Partners).
- Lean Manufacturing experience for year-on-year productivity improvements.
- Matrix/international experience; Large Molecule unit operation design/startup/operations.
Application:
- Apply at https://jobs.merck.com/us/en. Application deadline is stated on the posting.