Director, Operations

About the Role

Glenmark is seeking a Director to oversee the manufacturing, filling, and packaging of Sterile Injectable products at our Monroe, North Carolina facility. The site produces Sterile Injectable products in vials and syringe formats. This role involves managing machine resources, ensuring productivity, minimizing downtime, and guiding supervisors across multiple shifts. The Director will focus on reducing expenses, increasing productivity, and maintaining strict health and safety standards. Key responsibilities include setting production goals, motivating employees, and communicating challenges to senior management. Additional duties involve equipment qualification, process transfers, media fills, and maintaining aseptic manufacturing areas for exhibit and commercial batches. The role ensures compliance with all statutory and regulatory requirements in a time-sensitive manner.

Responsibilities

• Manage and evaluate machine resources to ensure productivity and minimal downtime.
• Support and guide supervisors across multiple shifts in the Sterile Injectable area.
• Reduce expenses and increase productivity while maintaining product safety and integrity.
• Ensure adherence to industry-standard health and safety guidelines.
• Set ambitious production goals and communicate them to key stakeholders.
• Provide motivation, support, and guidance to all employees.
• Communicate problems or obstacles to senior management.
• Create schedules to ensure optimal staffing levels and workflow efficiency.
• Support equipment qualification, process transfers, and media fills.
• Maintain aseptic manufacturing areas for exhibit and commercial batches.
• Ensure compliance with all statutory and regulatory requirements.
• Responsible for budget compliance and keeping manufacturing costs within the established budget.
• Lead plant-wide OEE initiatives to enhance efficiency in the Sterile Injectable area.
• Coordinate continuous improvement opportunities across manufacturing areas.
• Lead change, negotiate, and influence positive outcomes.
• Periodically review manufacturing capacities and implement additions as required.
• Ensure timely closure of batch records and related documents per CGMP and CGDP practices.
• Collaborate with Procurement, Quality Control, Quality Assurance, Regulatory, and R&D departments.
• Coordinate with other manufacturing locations for efficient project completion, product launches, and commercial supplies.
• Lead preparation for regulatory and customer audits in Sterile Injectable and Oral Solid Dosage areas.
• Develop the team through training and talent management programs.
• Design or implement manufacturing processes to adapt to market conditions and business strategies.
• Initiate energy conservation projects and monitor productivity matrices.
• Accountable for the safety management system of the Sterile Injectable area.

Requirements

• Bachelor’s degree in pharmacy, microbiology, engineering, or a relevant scientific discipline (required).
• Master’s degree in one of the listed fields (preferred).
• Minimum of 18+ years of experience in pharmaceutical manufacturing.
• Experience in sterile or aseptic manufacturing (required).
• Experience with prefilled syringes and vial filling technology through aseptic processing or terminal sterilization (ideal).
• Experience working in USFDA-regulated manufacturing facilities (required).

Skills

• Demonstrated understanding of manufacturing process technology, equipment, unit operations, and control technology.
• Strong hands-on experience in media fills and aseptic manufacturing.
• Functional knowledge of pharmaceutical manufacturing processes.
• Hands-on experience with pre-filled syringes and vial-filling technology (highly preferred).
• Working knowledge of conceptual and detailed design, project planning, execution, and qualification of biopharmaceutical facilities per cGMP requirements.