Associate Director, Operations
Merck
Position Description
Associate Director, Operations (Capital project start-up) in Durham, North Carolina. Oversee a portion of the manufacturing team for end-to-end drug substance/drug product processing (culture growth, harvest, filling, lyophilization, product inspection, utilities, warehouse, and QC labs). Build and lead the team and manufacturing strategy; establish start-up and execute manufacturing with stakeholder communication.
Responsibilities
- Hire, coach, and develop managers and technicians.
- Ensure execution to schedule.
- Own projects and improvement initiatives.
- Create and sustain a strong safety culture.
- Contribute to facility manufacturing team strategy.
- Direct routine process support and improvement activities.
- Serve as technical SME during regulatory inspections and audits.
- Provide technical guidance for daily production, projects, deviations, and changes.
- Guide facility operations as part of the facility leadership team.
- Adapt plans/priorities based on budget/profit plan and division scorecard.
- Ensure compliance with corporate/site/departmental procedures; ensure team training on new/revised processes.
- Identify and resolve technical/operational problems; collaborate across related units.
- Provide technical guidance to employees/colleagues/clients.
Qualifications
- Bachelorโs in Engineering/Science/related + 8+ years in Manufacturing/Pharma/Biotech/Vaccines, or Masterโs + 6+ years.
- Routine commercial manufacturing experience.
- Leadership of teams/projects; experience coaching/developing people.
- Strong communication; present complex data to diverse audiences.
- Technical expertise during regulatory inspections/audits.
- Project management and analytical skills.
Preferred
- GMP operations, tech transfer, capital projects, facility start-up, production/improvement.
- Regulated/GMP manufacturing and technical support.
- Aseptic processing (bulk, formulation, vial filling, lyophilization) and clean utilities.
- Change control systems and technical assessment in GMP environments.
- Sterile processing and sterility assurance practices.
Benefits / Incentives
- Annual bonus and long-term incentive (if applicable).
- Comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.
Application Instructions
Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Deadline is listed on the posting.