Primary Responsibilities:
- Partner across ExM Operations, ExM Quality, Business Development, Supply Chain Management, and Global Procurement to support API supply (intermediates and other critical materials) for new product introductions, sustained commercial supply, risk management, and sourcing.
- Lead, coach, and develop the team; oversee career development for direct reports.
- Use operational excellence methodologies to improve efficiency and effectiveness; drive continuous improvement via change and innovation.
- Ensure technical excellence in routine supply support to contract manufacturers.
- Lead technical efforts for competitiveness through targeted process optimization.
- Drive capability in Proactive Process Monitoring for robust manufacturing operations and early detection of process issues.
- Build a learning community around new technologies, ways of working, and new product introductions.
- Ensure technical capability building for internal and external teams.
- Build and leverage internal/external technical networks to solve complex cross-functional problems.
- Direct safe and compliant resolution of complex technical/business challenges using data-driven approaches aligned to quality, safety, regulatory, and trade compliance requirements.
- Partner with Operations and Quality Assurance to establish compliant manufacturing capabilities at partner CMOs.
- Oversee process scale-up/optimization, new technology deployment, pre-approval inspection readiness, validation protocols, and execution of process validation (PPQ) and Continued Process Verification.
Education Requirement:
- Bachelors (Chemical Engineering/Biochemical Engineering/Chemistry/Pharmaceutical Sciences) + 10 years relevant experience; or Masterβs + 7 years; or PhD + 5 years.
Qualifications/Required Skills:
- Leadership experience in Technical Operations, Process Development, Manufacturing, Quality Operations, or Engineering.
- Ability to resolve highly complex technical issues impacting supply continuity.
- Experience with traditional API processing and introducing new technologies/ways of working.
- Travel ~25%.
Preferred Skills:
- Familiarity with biocatalysts/enzyme manufacturing, flow chemistry, processing highly potent compounds, or sterile/low bioburden DS manufacturing.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is listed on the posting.