We are actively seeking a Senior Production Manager to be responsible for overall manufacturing and packaging for Nebulizer products at our new manufacturing facility in Monroe, North Carolina. The facility is designed to produce Nebulizer respules products. Major responsibilities include manage and evaluate machine resources to ensure productivity and minimal downtime, support and guide supervisors on three shifts in Nebulizer area, strive to reduce expenses and increase productivity, ensure all employees follow 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 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 support qualification of equipment, setting up plant systems and processes, site transfer of manufacturing processes, media fills, maintaining aseptic manufacturing areas and manufacturing of exhibit and commercial batches. The Senior Production Manager, Nebulizer Products will ensure that manufacturing and packaging operations are carried out in compliance with all statutory and regulatory requirements in an effective and time-sensitive manner.
- Responsible for the budget compliance for the operations in Nebulizer area.
- Responsible for keeping the manufacturing costs within established budget.
- Responsible for plant wide OEE initiatives to enhance the overall efficiency of the Nebulizer area.
- Shall lead and coordinate the continuous improvement opportunities across the Nebulizer area.
- Responsible for leading change with ability to negotiate and influence positive outcomes.
- Ensure that 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.
- Collaborate with other departments, such as Procurement, Quality Control, Quality Assurance, Regulatory, and R&D to effectively run the operations.
- Coordination with the teams and other manufacturing locations to ensure the projects, product filings, product launches, commercial supplies etc., are done in the most efficient way.
- Lead for the preparation of regulatory and customer audits for the Nebulizer area.
- Develop the team and people development through training and talent management programs.
- Design or Implement manufacturing processes that support business strategies adapted to changing market conditions, new business opportunities or cost reduction drive.
- Take up energy conservation projects.
- To develop and monitor productivity matrices and to improve these over the time.
- To initiate and accountable for the safety management system of the Nebulizer area.
- A Bachelor’s degree in pharmacy, microbiology, engineering, or relevant scientific discipline is required for consideration of this position. A Master’s degree in one of the listed fields is preferred.
- A minimum of 8 years of experience in pharmaceutical manufacturing is required for consideration for this position.
- Experience in sterile or aseptic manufacturing is required. Ideal candidate will have experience in Blow, Fill, and Seal technology.
- Experience with working in USFDA regulated manufacturing facilities is required.
- Demonstrated understanding of all applicable manufacturing process technology, equipment, unit operations and control technology.
- Strong hands-on experience of media fills and aseptic manufacturing is required. Functional knowledge of pharmaceutical manufacturing processes is required.
- Hands on experience with Blow, Fill and Seal technologies highly preferred.
- Demonstrated working knowledge and understanding of conceptual, detailed design, project planning, execution and qualification of biopharmaceutical facilities as per cGMP requirements.
- Change Agent, Servant Based Leadership.
- Demonstrated commitment to continuous improvement and methodologies, Formal Operational Excellence training is preferred.