Director, Technical Operations (Small Molecule Drug Substance)
Merck
August 26, 2026
On-site
Elkton, VA
Operations
Director and Technical Operations Leader for Small Molecule Drug Substance technical operations.
Responsibilities:
- Lead right-first-time execution; drive deviation reduction, root cause analysis, CAPA effectiveness, and reliability improvements for stable, compliant supply.
- Serve as site Subject Matter Expert (SME) for equipment and facility-related technical issues.
- Own site-level product introductions and technology transfer strategy/execution (including receiving unit responsibilities).
- Integrate operations with product science for end-to-end risk assessment and control strategy alignment; ensure on-time, right-first-time introductions.
- Ensure execution readiness via process stewardship and operational risk management.
- Resolve technical challenges to sustain supply; support regulatory technical queries.
- Provide escalation support for complex, multi-site technical issues; ensure regulatory inspection and internal audit readiness with defensible evidence and data integrity/traceability.
- Monitor performance trends; lead technical risk reviews and mitigations; interpret technical/operational data to guide prioritization/investment.
- Lead transformational people and operating-model change: safety culture, scientific rigor, accountability, inclusive leadership, workforce planning/succession, digital/analytics capabilities sponsorship, and portfolio prioritization/resource allocation.
Qualifications:
- Bachelor’s degree (preferably Science or Engineering).
- 10+ years’ experience in small molecule drug substance process/product development and/or manufacturing technical operations.
- 7+ years’ experience with advanced degree in Chemistry, Chemical Engineering, or related discipline.
- Track record in new product introduction, tech transfer, PPQ, commercial scale-up, process validation, and lifecycle management.
- Knowledge of GMP, ICH guidelines, process safety, Quality Systems; inspection readiness leadership.
- Experience leading complex investigations.
- Evidence of organizational transformation (capability building, operating model changes, cross-functional alignment).
Required/Preferred Skills (from posting):
Business process improvements, change management, cross-functional leadership, GMP compliance, operational excellence, operation risk management, process safety, risk assessments, technology transfer, transformational leadership, stakeholder communications, strategic thinking, succession planning.
Application instructions:
Apply at https://jobs.merck.com/us/en (deadline stated on posting).
Responsibilities:
- Lead right-first-time execution; drive deviation reduction, root cause analysis, CAPA effectiveness, and reliability improvements for stable, compliant supply.
- Serve as site Subject Matter Expert (SME) for equipment and facility-related technical issues.
- Own site-level product introductions and technology transfer strategy/execution (including receiving unit responsibilities).
- Integrate operations with product science for end-to-end risk assessment and control strategy alignment; ensure on-time, right-first-time introductions.
- Ensure execution readiness via process stewardship and operational risk management.
- Resolve technical challenges to sustain supply; support regulatory technical queries.
- Provide escalation support for complex, multi-site technical issues; ensure regulatory inspection and internal audit readiness with defensible evidence and data integrity/traceability.
- Monitor performance trends; lead technical risk reviews and mitigations; interpret technical/operational data to guide prioritization/investment.
- Lead transformational people and operating-model change: safety culture, scientific rigor, accountability, inclusive leadership, workforce planning/succession, digital/analytics capabilities sponsorship, and portfolio prioritization/resource allocation.
Qualifications:
- Bachelor’s degree (preferably Science or Engineering).
- 10+ years’ experience in small molecule drug substance process/product development and/or manufacturing technical operations.
- 7+ years’ experience with advanced degree in Chemistry, Chemical Engineering, or related discipline.
- Track record in new product introduction, tech transfer, PPQ, commercial scale-up, process validation, and lifecycle management.
- Knowledge of GMP, ICH guidelines, process safety, Quality Systems; inspection readiness leadership.
- Experience leading complex investigations.
- Evidence of organizational transformation (capability building, operating model changes, cross-functional alignment).
Required/Preferred Skills (from posting):
Business process improvements, change management, cross-functional leadership, GMP compliance, operational excellence, operation risk management, process safety, risk assessments, technology transfer, transformational leadership, stakeholder communications, strategic thinking, succession planning.
Application instructions:
Apply at https://jobs.merck.com/us/en (deadline stated on posting).