Technical Lead (Chemical Technical Operations β Small Molecule API External Manufacturing)
Responsibilities:
- Manage the technical interface between the company and External Partners (EP)
- Provide process support to resolve production issues for existing supply products
- Evaluate and manage process change requests; proactively assess/manage process/technical risks
- Guide process improvement and capacity optimization
- Oversee EPs during New Product Introductions and Technical Transfers (pre-execution risk identification; on-site execution support; post-execution support)
- Operate independently on priorities with assigned EPs
- Maintain strong compliance and EHS focus to drive supply excellence
- Serve as primary technical contact while coordinating with impacted company sites and EPs
- Collaborate cross-functionally to ensure end-to-end product supply
- Initiate and drive change controls to completion
- Provide rapid support to minimize supply disruptions
- Collaborate with Research Laboratories during NPI/tech transfers and new technology development
- Conduct technical due diligence and expert consultation on chemical manufacturing
- Review process change requests and deviation reports to ensure regulatory compliance
- Perform proactive process monitoring for early detection of process issues
Education & Minimum Requirements:
- BS in technical field (Chemical/Biochemical Engineering, Chemistry, or Pharmaceutical Sciences) + 7 years relevant experience; or MS + 5 years; or PhD + 3 years
- Experience in small molecule API process production, development, optimization, and tech transfer
- Travel up to 50%
Qualifications:
- Exceptional organizational skills; ability to work independently
- Leadership with global mindset/end-to-end supply chain perspective; strong cross-functional collaboration
- Ability to solve complex technical challenges and influence stakeholders
- Strong understanding of small molecule pharmaceutical manufacturing
- Strong technical communication tailored to different organizational levels
Required/Preferred Skills:
- Required: Chemical manufacturing, CMO management, process/technical transfer, process monitoring, manufacturing operations/processes/scale-up, external manufacturing/partners, global mindset, communication management
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if current employee). Deadline per posting.