Director, Technical Operations (Small Molecule Drug Product)
Merck
June 29, 2026
On-site
Elkton, VA
Operations
Director and Technical Operations (Small Molecule Drug Product)
Responsibilities
- Lead small molecule drug product technical operations: manufacturing processes, equipment, process engineering, scale-up, validation, troubleshooting, and facility systems.
- Serve as site SME for equipment and facility technical issues.
- Manage intersections of process, product, equipment, and facility design for robust performance.
- 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, control strategy alignment, and right-first-time introductions.
- Ensure execution readiness via process stewardship and operational risk management.
- Resolve technical challenges to sustain supply; support regulatory technical queries.
- Drive GMP/data integrity/audit readiness and provide authoritative technical responses with defensible evidence.
- Lead complex, multi-site technical escalations; readiness for inspections and internal audits.
- Monitor technical performance, lead technical risk reviews, interpret data for prioritization/investment, and feed insights back to development/network strategy.
- Provide transformational people leadership: safety culture, scientific rigor, accountability, continuous improvement, workforce planning, capability-building, and change/digital process improvement.
Qualifications
- Bachelor’s degree (preferably Science or Engineering).
- 10+ years in small molecule drug product process/product development and/or manufacturing technical operations.
- 7+ years with an advanced degree in Chemistry, Chemical Engineering, or related.
- Proven track record: new product introduction, tech transfer, PPQ, commercial scale-up, process validation, lifecycle management.
- Knowledge of GMP, ICH guidelines, process safety, and Quality Systems; inspection readiness leadership.
- Strong experience leading complex investigations.
Required/Related skills
- Cross-functional leadership, operational excellence, operational risk management, stakeholder communications, strategic thinking, transformational leadership, technology transfer, succession planning, change management, manufacturing scale-up, GMP compliance, data integrity mindset.
Benefits (explicitly stated)
- Annual bonus and long-term incentive (if applicable); comprehensive medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application
- Apply at https://jobs.merck.com/us/en (deadline listed on posting).
Responsibilities
- Lead small molecule drug product technical operations: manufacturing processes, equipment, process engineering, scale-up, validation, troubleshooting, and facility systems.
- Serve as site SME for equipment and facility technical issues.
- Manage intersections of process, product, equipment, and facility design for robust performance.
- 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, control strategy alignment, and right-first-time introductions.
- Ensure execution readiness via process stewardship and operational risk management.
- Resolve technical challenges to sustain supply; support regulatory technical queries.
- Drive GMP/data integrity/audit readiness and provide authoritative technical responses with defensible evidence.
- Lead complex, multi-site technical escalations; readiness for inspections and internal audits.
- Monitor technical performance, lead technical risk reviews, interpret data for prioritization/investment, and feed insights back to development/network strategy.
- Provide transformational people leadership: safety culture, scientific rigor, accountability, continuous improvement, workforce planning, capability-building, and change/digital process improvement.
Qualifications
- Bachelor’s degree (preferably Science or Engineering).
- 10+ years in small molecule drug product process/product development and/or manufacturing technical operations.
- 7+ years with an advanced degree in Chemistry, Chemical Engineering, or related.
- Proven track record: new product introduction, tech transfer, PPQ, commercial scale-up, process validation, lifecycle management.
- Knowledge of GMP, ICH guidelines, process safety, and Quality Systems; inspection readiness leadership.
- Strong experience leading complex investigations.
Required/Related skills
- Cross-functional leadership, operational excellence, operational risk management, stakeholder communications, strategic thinking, transformational leadership, technology transfer, succession planning, change management, manufacturing scale-up, GMP compliance, data integrity mindset.
Benefits (explicitly stated)
- Annual bonus and long-term incentive (if applicable); comprehensive medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application
- Apply at https://jobs.merck.com/us/en (deadline listed on posting).