Director, Technical Operations (Small Molecule Drug Substance)
Merck
June 29, 2026
On-site
Elkton, VA
Operations
Director and Technical Operations Leader (Small Molecule Drug Substance)
Responsibilities
- Serve as site SME for equipment and facility-related technical issues.
- Own small molecule drug substance technical operations: equipment, facility/infrastructure systems, site operations, process engineering, scale-up, validation, and troubleshooting.
- Manage intersections of process, product, equipment, and facility design to ensure robust performance.
- Lead technology transfer and site-level product introductions (receiving unit responsibilities); ensure end-to-end risk assessment and control strategy alignment.
- Ensure execution readiness via process stewardship and operational risk management.
- Resolve technical challenges to sustain supply; support regulatory technical queries.
- Drive deviation reduction, root cause analysis, CAPA effectiveness, and reliability improvements; support right-first-time execution.
- Act as escalation point for complex, multi-site technical issues.
- Prepare for regulatory inspections and internal audits; provide rapid technical responses with defensible evidence; uphold data integrity and traceability.
- Monitor performance trends; lead technical risk reviews and implement mitigations.
- Interpret technical/operational data to guide prioritization and investment.
- Lead transformational and people initiatives: safety culture, scientific rigor, accountability, inclusive leadership, workforce planning, succession planning, and capability building.
- Sponsor digital/analytics capabilities (e.g., process data platforms, CPV analytics) and lead process improvement while maintaining compliance.
Qualifications
- Bachelor’s degree (preferably Science or Engineering).
- 10+ years in small molecule drug substance process/product development and/or manufacturing technical operations.
- 7+ years with an advanced degree in Chemistry, Chemical Engineering, or related field.
- Proven experience in new product introduction, tech transfer, PPQ, commercial scale-up, process validation, and lifecycle management.
- Knowledge of GMP, ICH guidelines, process safety, and Quality Systems; inspection readiness leadership.
- Strong experience leading complex investigations and driving organizational transformation.
Required/Preferred Skills (from posting)
Required: GMP compliance, operational excellence, operational risk management, process safety, technology transfer, transformational leadership, stakeholder communications, manufacturing scale-up, change management, risk assessments, cross-functional leadership, decision making, succession planning.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).
Responsibilities
- Serve as site SME for equipment and facility-related technical issues.
- Own small molecule drug substance technical operations: equipment, facility/infrastructure systems, site operations, process engineering, scale-up, validation, and troubleshooting.
- Manage intersections of process, product, equipment, and facility design to ensure robust performance.
- Lead technology transfer and site-level product introductions (receiving unit responsibilities); ensure end-to-end risk assessment and control strategy alignment.
- Ensure execution readiness via process stewardship and operational risk management.
- Resolve technical challenges to sustain supply; support regulatory technical queries.
- Drive deviation reduction, root cause analysis, CAPA effectiveness, and reliability improvements; support right-first-time execution.
- Act as escalation point for complex, multi-site technical issues.
- Prepare for regulatory inspections and internal audits; provide rapid technical responses with defensible evidence; uphold data integrity and traceability.
- Monitor performance trends; lead technical risk reviews and implement mitigations.
- Interpret technical/operational data to guide prioritization and investment.
- Lead transformational and people initiatives: safety culture, scientific rigor, accountability, inclusive leadership, workforce planning, succession planning, and capability building.
- Sponsor digital/analytics capabilities (e.g., process data platforms, CPV analytics) and lead process improvement while maintaining compliance.
Qualifications
- Bachelor’s degree (preferably Science or Engineering).
- 10+ years in small molecule drug substance process/product development and/or manufacturing technical operations.
- 7+ years with an advanced degree in Chemistry, Chemical Engineering, or related field.
- Proven experience in new product introduction, tech transfer, PPQ, commercial scale-up, process validation, and lifecycle management.
- Knowledge of GMP, ICH guidelines, process safety, and Quality Systems; inspection readiness leadership.
- Strong experience leading complex investigations and driving organizational transformation.
Required/Preferred Skills (from posting)
Required: GMP compliance, operational excellence, operational risk management, process safety, technology transfer, transformational leadership, stakeholder communications, manufacturing scale-up, change management, risk assessments, cross-functional leadership, decision making, succession planning.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).