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 :

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 :

Stakeholder :

Innovation :

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 :

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.