Sr. Spclst, Project Management
Merck
3 days ago
Remote friendly (Rahway, NJ)
United States
Operations
Senior Specialist, External Development & Manufacturing (ExDM) – Program Lead (P3)
Key Responsibilities
- Lead execution of external manufacturing programs across Contract Manufacturing Organizations (CMOs): planning, coordination, risk management, and issue resolution.
- Track and manage CMO KPIs/metrics.
- Represent ExDM on project teams and align external manufacturing strategy to program objectives.
- Manage GMP-related activities (batch record/specification review, change control, release support, investigations, and material coordination).
- Liaise with external partners to drive performance in quality, delivery, and cost.
- Oversee billing, purchase orders, and financial forecasting; improve financial workflows/reporting.
- Collaborate across Technical Operations, Quality, Global Clinical Supplies, Procurement, and others to resolve technical/operational challenges.
- Identify and implement process improvements; act as SME in selected areas.
- Mentor junior team members.
- Use digital tools/analytics/AI-enabled platforms to improve efficiency and communication.
Education Minimum Requirement
- B.S. + 5+ years relevant industrial experience, or
- M.S. + 3 years in Chemical Engineering, Pharmaceutical Sciences, or related discipline.
Required Experience and Skills
- Clinical manufacturing/supply chain/external manufacturing management experience in pharma.
- Working knowledge of GMP operations, batch release, investigations, and quality systems.
- Strong project management, problem-solving, and stakeholder management.
- Ability to work independently in a matrixed environment.
Preferred Experience and Skills
- Experience with external partners/CMOs; advanced degree.
- Experience leading external manufacturing/development programs.
- Demonstrated process improvement and scalable solutions.
- Ability to influence cross-functional teams and external partners; mentor experience.
- Digital fluency (analytics and AI-enabled tools).
Benefits (if applicable)
- Annual bonus and long-term incentive (if applicable).
- Comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.
Key Responsibilities
- Lead execution of external manufacturing programs across Contract Manufacturing Organizations (CMOs): planning, coordination, risk management, and issue resolution.
- Track and manage CMO KPIs/metrics.
- Represent ExDM on project teams and align external manufacturing strategy to program objectives.
- Manage GMP-related activities (batch record/specification review, change control, release support, investigations, and material coordination).
- Liaise with external partners to drive performance in quality, delivery, and cost.
- Oversee billing, purchase orders, and financial forecasting; improve financial workflows/reporting.
- Collaborate across Technical Operations, Quality, Global Clinical Supplies, Procurement, and others to resolve technical/operational challenges.
- Identify and implement process improvements; act as SME in selected areas.
- Mentor junior team members.
- Use digital tools/analytics/AI-enabled platforms to improve efficiency and communication.
Education Minimum Requirement
- B.S. + 5+ years relevant industrial experience, or
- M.S. + 3 years in Chemical Engineering, Pharmaceutical Sciences, or related discipline.
Required Experience and Skills
- Clinical manufacturing/supply chain/external manufacturing management experience in pharma.
- Working knowledge of GMP operations, batch release, investigations, and quality systems.
- Strong project management, problem-solving, and stakeholder management.
- Ability to work independently in a matrixed environment.
Preferred Experience and Skills
- Experience with external partners/CMOs; advanced degree.
- Experience leading external manufacturing/development programs.
- Demonstrated process improvement and scalable solutions.
- Ability to influence cross-functional teams and external partners; mentor experience.
- Digital fluency (analytics and AI-enabled tools).
Benefits (if applicable)
- Annual bonus and long-term incentive (if applicable).
- Comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.