Supervisor Manufacturing- 2nd Shift


1. Will supervise and manage the daily aseptic filling operations / packaging operation at RMD Branchburg. Manage filling / packaging departments (n=5 to 40 staff) which conduct the filling and labeling and packaging of diagnostic reagents. Managing the schedule and work assignments for the filling / packaging and labeling areas. Manages the scheduling of automated Filling/ Packaging and labeling equipment meets production demands. Resolves scheduling conflicts and production issues in order to meet production and replenishment demands. Ensures all area personnel are trained in job specific SOPs and that all operations are performed in a manners compliant with Master Records and associated SOPs. Leads project-based activities (e. g., new product transfers product validation activities) to support departmental and company goals. Maintains control of work group expenses within limits of DOA. Provides developmental plans for direct reports and conducts on-going performance management activities.

2. Depending upon primary focus of position, manages work groups which conduct aseptic filling operations, packaging, planning and logistics routine activities. Is responsible for the accuracy, quality and timeliness of Filling / Packaging operations and product supply. Keeps manager informed of product and project status, particularly of significant observations and results in critical areas. Manages area and assigned personnel to ensures that Filling / Packaging group performs work according to established internal safety guidelines and procedures, and as specified by appropriate external regulatory agencies (e. g., OSHA, FDA, ISO). The individual serves as a technical resource for the specific area of supervision assigned. Individual is a mentor to the members of the work group and resolves issues encountered in the logistics and planning processes to improve performance. Provides definition and plans for timely achievement of overall product or project goals and to the expeditious transfer of technologies.

3. Manages and Coordinates filling / packaging schedule in order to ensures manpower is deployed to meet fill schedule requirements. Individual will leads investigations, write the investigation reports, and advance through the quality system. Makes recommendations, provides or implements process improvements and document improvements. Prepares complex reports, presentations, protocols and other documents.

4. Individual manages the training of individuals in responsible areas to ensures training is current for all area personnel. Coordinates with Environmental Monitoring Group to address excursions. Ensures area SOPs are current and accurate for all operations performed. Writes and/or revises documents (e. g., SOPs, Variances, Rework Orders, Change Requests) to comply with cGMP/ QSR practices.

5. Individual will manage and supervises day-to-day operations of the area of responsibility, coordinating the scheduling and execution of planning and logistics procedures. Defines and monitors project timelines, ensuring timely achievement of overall project goals and establishing priorities. Performs supervisory functions including performance management and career development guidance for direct reports. Responsible for providing appropriate training and development opportunities for staff.

6. Participates in routine training activities to maintain/enhance own technical skill level and supervisory abilities.


Minimum (required): Bachelor s or Master's degree in Science related field with 4 to 10 years of experience, or equivalent combination of education and work-related experience.

Preferred: Bachelor's degree

Job-related Experience:

Minimum (required): See Education. Supervisory/management experience

Other Qualifications:

In-depth understanding of aseptic filling, environmental monitoring, GMP, ISO, QSR requirements. Strong problem-solving skills. Ability to communicate effectively in small group settings. Ability to summarize complex information and present same to senior staff.

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