Description:

The Manager, Manufacturing Operations will be responsible for all activities pertaining to manufacturing, including pharmacy, mixing, granulation, tablet manufacturing, and encapsulation; coating operations including potent and hormonal areas with the ability to be hands-on, and other areas as required. The Manager will be responsible for ensuring the production process runs smoothly, efficiently, and in compliance with safety and quality standards. This individual will manage production teams, optimize workflows, and implement continuous improvement strategies to meet both company and customer demands.

Schedule:

2nd Shift 3:30pm - 12:00am Tuesday to Saturday

Essential Functions:

• Serves as the Manufacturing Department’s representative in quality investigations, including but not limited to handling deviations, complaints, out-of-specification issues, material disposition inquiries, and change control. Manage the implementation and effectiveness verification of corrective and preventive actions related to these investigations. Ensures compliance with all procedures and policies across manufacturing, maintenance, packaging, quality, regulatory, logistics, safety, and human resources, in alignment with company policies and FDA regulations while overseeing departmental audits to ensure all operations are compliant.

• Plans and coordinates daily activities, executing management strategies, budget planning, and allocating funds for new projects to meet monthly targets. Resolves technical challenges and leads investigations impacting the technical scope, providing recommendations for potential solutions. Prepares weekly and monthly reports covering productivity, utilization, cGMP compliance, and training status.

• Supervise, train, and motivate production staff to ensure high performance and productivity. Provide daily guidance and support to team members, ensuring alignment with operational goals. Provide feedback and conduct performance reviews for direct reports. Promote training and skill development to ensure the team is well-equipped to meet operational demands.

• Collaborates with the Planning Department to identify products due for the current month and forecasts for upcoming months, preparing and submitting reports to the Planning Manager to prevent backorders. Reviews manufacturing and packaging requirements based on the 3-month rolling forecast. Manages production priorities in coordination with the QC and QA departments, ensuring timely raw material releases and sampling. Works strategically with the Planning Manager to implement conditional releases of APIs.

• Reviews daily batch records and offers recommendations to improve process efficiency and effectiveness. Evaluates current production systems and processes, identifying any gaps and implementing corrective actions to address them. Develops and introduces innovative methods to reduce cycle times and costs while maintaining or enhancing quality, using Six Sigma and LEAN principles.

• Collaborates closely with other members of the MST team, as well as teams from Operations, Regulatory, Quality, Laboratory, and other departments, to ensure the seamless implementation of new processes, in coordination with the Quality team.

Additional Responsibilities:

• Other duties as assigned.