Director of Manufacturing Operations

Manufacturing Operations Leader – Pharmaceutical Manufacturing

Summary

Our client, a pharmaceutical organization, is seeking an experienced manufacturing leader to oversee a complex, 24/7 operation spanning aseptic production and packaging. This individual will lead manufacturing teams, ensure reliable product supply and GMP compliance, drive operational improvements, and support site growth and capacity expansion.

Duties / Expectations of Role

• Lead manufacturing operations across aseptic bulking, filling, and packaging, overseeing managers, supervisors, and large production teams.


• Improve operational performance, including overall equipment effectiveness (OEE), equipment reliability, manufacturing efficiency, and schedule attainment.


• Lead complex investigations, root cause analysis, and deviation reduction efforts.


• Maintain FDA inspection readiness and support regulatory and customer audits.


• Partner with Quality, Supply Chain, Engineering, Maintenance, and Technical Operations to resolve issues and meet production goals.


• Support manufacturing scale-up, capacity expansion, and continuous improvement initiatives.


• Develop management teams through coaching, clear expectations, and accountability.


• Balance daily operational needs with long-term planning while promoting safety, quality, compliance, and employee engagement.

Mandatory Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.


• 10+ years of pharmaceutical manufacturing experience, including extensive GMP and aseptic manufacturing experience.


• Demonstrated experience leading managers, supervisors, and large manufacturing teams.


• Strong technical knowledge of manufacturing equipment and complex production processes.


• Experience managing investigations, deviations, corrective and preventive actions (CAPAs), and compliance activities.


• Experience supporting FDA inspections and regulatory audits.


• Proven ability to lead in a fast-paced manufacturing environment.


• Strong leadership, communication, and cross-functional collaboration skills.


• Ability to work fully onsite and support a 24/7 manufacturing operation.

Preferred Qualifications

• Director- or Senior Director-level manufacturing leadership experience.


• Sterile injectable, aseptic filling, and packaging operations experience.


• Engineering background with equipment troubleshooting expertise.


• Experience with Lean Manufacturing, continuous improvement, or operational excellence.


• Manufacturing scale-up, facility expansion, or automation implementation experience.


• Experience leading highly manual, technically complex manufacturing operations.

Term & Start

• Immediate need; fully onsite.


• Contract, contract-to-hire, or direct hire arrangements considered.


• Potential long-term leadership opportunity based on organizational needs and candidate fit.