Director, Operations - API
Merck
August 26, 2026
On-site
Elkton, VA
Operations
Job Purpose
Director, IPT Leader, API provides leadership, technical and operational expertise to the Integrated Process Team (IPT) supporting API manufacturing at the Elkton, VA site. Accountable for the future operating model (project/site readiness, organizational design, operating rhythms, governance, IPT culture, Ways of Working, performance standards) and later full IPT leadership for safe, compliant, reliable API operations.
Primary Responsibilities
- Site Leadership and Strategy: Align IPT priorities with site/company strategy; develop tactical/strategic plans for API ramp-up; coordinate with site/above-site teams; represent IPT/site with stakeholders/partners.
- Future-State Operating Model and Ramp-Up: Lead future-state operating model; support start-up, ramp-up, and readiness; define org structure/culture/rhythms/governance; ensure readiness plans, risk assessments, and implementation execution.
- Operations Excellence: Ensure cGMP-compliant, reliable, RFT API operations; lead operational reviews/daily routines; drive structured problem-solving and metrics; support production planning/resource deployment/issue resolution; promote Lean and continuous improvement.
- Financial Stewardship: Own/support IPT budget (operating/capital); identify productivity/efficiency/cost opportunities; allocate resources effectively.
- Quality & Safety & People Leadership: Promote quality/inspection readiness; manage deviations/investigations/CAPA; partner with Quality/EHS/Engineering/Technical/Supply Chain; ensure training/documentation/change management; champion safety/risk management; lead/coach/develop teams.
Minimum Required Qualifications
- Bachelor’s degree (preferred: Chemistry/Chemical Engineering/Pharmaceutical Sciences/Engineering or related).
- 10+ years in pharmaceutical or regulated manufacturing; leadership experience in Manufacturing/Technical Ops/Quality Ops/Engineering/Production Planning; direct/indirect report leadership.
- Strong cGMP/quality systems, regulatory readiness, safety/environmental practices; operational planning/project leadership/ramp-up.
- Strong business acumen; financial stewardship/resource planning; Lean Six Sigma/continuous improvement; communication/coaching/change leadership.
Preferred Qualifications
- Master’s degree.
- Small molecule API manufacturing or commercial pharma operations; experience with start-up/transformation/ramp-up.
- Future-state operating model/organizational governance experience; Lean Six Sigma certification.
- Matrixed global manufacturing; talent development/engagement; capacity/capital/supply planning and S&OP; inspection readiness/deviation management/quality systems.
Benefits
- Eligible for annual bonus and long-term incentive (if applicable) and comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, compassionate and sick days).
Application Instructions
Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.
Director, IPT Leader, API provides leadership, technical and operational expertise to the Integrated Process Team (IPT) supporting API manufacturing at the Elkton, VA site. Accountable for the future operating model (project/site readiness, organizational design, operating rhythms, governance, IPT culture, Ways of Working, performance standards) and later full IPT leadership for safe, compliant, reliable API operations.
Primary Responsibilities
- Site Leadership and Strategy: Align IPT priorities with site/company strategy; develop tactical/strategic plans for API ramp-up; coordinate with site/above-site teams; represent IPT/site with stakeholders/partners.
- Future-State Operating Model and Ramp-Up: Lead future-state operating model; support start-up, ramp-up, and readiness; define org structure/culture/rhythms/governance; ensure readiness plans, risk assessments, and implementation execution.
- Operations Excellence: Ensure cGMP-compliant, reliable, RFT API operations; lead operational reviews/daily routines; drive structured problem-solving and metrics; support production planning/resource deployment/issue resolution; promote Lean and continuous improvement.
- Financial Stewardship: Own/support IPT budget (operating/capital); identify productivity/efficiency/cost opportunities; allocate resources effectively.
- Quality & Safety & People Leadership: Promote quality/inspection readiness; manage deviations/investigations/CAPA; partner with Quality/EHS/Engineering/Technical/Supply Chain; ensure training/documentation/change management; champion safety/risk management; lead/coach/develop teams.
Minimum Required Qualifications
- Bachelor’s degree (preferred: Chemistry/Chemical Engineering/Pharmaceutical Sciences/Engineering or related).
- 10+ years in pharmaceutical or regulated manufacturing; leadership experience in Manufacturing/Technical Ops/Quality Ops/Engineering/Production Planning; direct/indirect report leadership.
- Strong cGMP/quality systems, regulatory readiness, safety/environmental practices; operational planning/project leadership/ramp-up.
- Strong business acumen; financial stewardship/resource planning; Lean Six Sigma/continuous improvement; communication/coaching/change leadership.
Preferred Qualifications
- Master’s degree.
- Small molecule API manufacturing or commercial pharma operations; experience with start-up/transformation/ramp-up.
- Future-state operating model/organizational governance experience; Lean Six Sigma certification.
- Matrixed global manufacturing; talent development/engagement; capacity/capital/supply planning and S&OP; inspection readiness/deviation management/quality systems.
Benefits
- Eligible for annual bonus and long-term incentive (if applicable) and comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, compassionate and sick days).
Application Instructions
Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.