Director, Operations

Director Of Sterile Injectable Manufacturing

Glenmark is actively seeking a Director to be responsible for the overall manufacturing, filling, and packaging of Sterile Injectable products at our manufacturing facility in Monroe, North Carolina.

The facility is designed to produce Sterile Injectable products in vials and syringe formats. Significant responsibilities include managing and evaluating machine resources to ensure productivity and minimal downtime, supporting and guiding supervisors multiple shifts in the Sterile Injectable area, striving to reduce expenses and increase productivity, ensuring all employees follow industry standard health and safety guidelines, setting ambitious production goals and communicate them to key stakeholders, provide motivation, support, and guidance to all employees, communicate any problems or obstacles to senior management, create schedules for employees to ensure optimum staffing levels and establish workflow policies that enhance speed and efficiency without compromising product safety or integrity.

Additional responsibilities include supporting the qualification of equipment, setting up plant systems and processes, site transfer of manufacturing processes, media fills, maintaining aseptic manufacturing areas, and manufacturing exhibit and commercial batches. The Director of Operations will ensure that manufacturing and packaging operations comply with all statutory and regulatory requirements effectively and in a time-sensitive manner.

Overall job responsibilities include:

• Financial: Responsible for budget compliance with the operations of the sterile injectable area. Responsible for keeping the manufacturing costs within the established budget.
• Operational Excellence: Responsible for plant-wide OEE initiatives to enhance the overall efficiency of the Sterile Injectable area. Shall lead and coordinate the continuous improvement opportunities across manufacturing areas. Responsible for leading change with the ability to negotiate and influence positive outcomes. Ensure the manufacturing capacities are periodically reviewed and prepare and implement capacity additions when required. Ensure timely closure of batch records and related documents (i.e., protocols, incidents, change controls, etc.) per CGMP and CGDP practices.
• Stakeholder: Collaborate with other departments, such as Procurement, Quality Control, Quality Assurance, Regulatory, and R&D, to run the operation effectively. Coordinating with the teams and other manufacturing locations to ensure the most efficient completion of projects, product filings, product launches, commercial supplies, etc. Lead in preparing regulatory and customer audits for the Sterile Injectable and Oral Solid Dosage area. Develop the team and people development through training and talent management programs.
• Innovation: Design or Implement manufacturing processes that support business strategies adapted to changing market conditions, new business opportunities, or cost reduction. Take up energy conservation projects. To develop and monitor productivity matrices and improve these over time. To initiate and be accountable for the safety management system of the Sterile Injectable area.

Education: A Bachelor's degree in pharmacy, microbiology, engineering, or a relevant scientific discipline is required for consideration for this position. A Master's degree in one of the listed fields is preferred.

Experience: A minimum of 18+ years of experience in pharmaceutical manufacturing is required for consideration for this position. Experience in sterile or aseptic manufacturing is required. The ideal candidate will have experience in prefilled syringes and vial filling technology through aseptic processing or terminal sterilization. Experience working in USFDA-regulated manufacturing facilities is required.

Knowledge and Skills: Demonstrated understanding of all applicable manufacturing process technology, equipment, unit operations, and control technology. Strong hands-on experience in media fills and aseptic manufacturing is required. Functional knowledge of pharmaceutical manufacturing processes is required. Hands-on experience with Pre-filled syringes and vial-filling technology is highly preferred. Demonstrated working knowledge and understanding of conceptual, detailed design, project planning, execution, and qualification of biopharmaceutical facilities as per cGMP requirements.