Director, Operations - API

About the role

The Director, Operations - API leads the Integrated Process Team (IPT) for API manufacturing at the Elkton, VA site, shaping the operating model, driving ramp‑up, and ensuring safe, compliant, and efficient production.

Key responsibilities

• Lead strategic and tactical planning for site build‑out, ramp‑up, and operational readiness.
• Define organizational structure, culture, operating rhythms, governance, and performance standards.
• Ensure safe, compliant, reliable API operations and drive continuous improvement.
• Oversee budget planning, financial stewardship, and resource allocation.
• Promote quality and safety culture, manage cGMP compliance, deviations, and corrective actions.
• Coach and develop IPT leaders and contributors, fostering accountability and learning.

Required profile

• Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Engineering or related field.
• 10+ years experience in regulated pharmaceutical manufacturing with leadership in manufacturing, technical operations, quality, engineering or production planning.
• Proven experience in site start‑up, ramp‑up, project leadership and operational planning.
• Strong business acumen, financial stewardship, and Lean Six Sigma or continuous improvement expertise.

Required skills

• API manufacturing
• cGMP compliance
• Lean Six Sigma
• Project management
• Operational excellence
• Capacity planning
• Capital planning
• Data analysis
• Financial budgeting
• Manufacturing quality control
• Process optimization
• Production management
• Production scheduling
• Regulatory compliance