Supervisor, Manufacturing

Brief Job Description

The Supervisor of Manufacturing is a leader for the Process Operations (fill). In this capacity, the Supervisor manages the Aseptic Filling Operations and Process Execution to produce high quality product in accordance with the PET (Process Execution Team) operating strategy. As a responsible leader for the operation (potentially with other Supervisors). This must be done while maintaining effective employee relations and compliance to cGMP, other regulatory and SOP requirements, as well as EHS obligations and Resilience standards.

• Provides direction to PET personnel in the efficient use of equipment and materials to produce quality products in accordance with regulations.
• Responsible for all PET activity to include coordination of support staff, scheduling and improvement.
• Promotes the use of safe work practices during all aspects of production and ensures all external and internal EHS standards are met daily.
• Accountable for training of PET personnel on equipment, processes and Standard Operating Procedures. Partners with PET Coach to develop training plans and assist in providing resources for training.
• Ensures that cGMP’s are used and followed during production of products so that all FDA and international regulations are met. Responds to monthly internal audit observations.
• Promotes a positive work environment by effectively administering Human Resources policies and procedures including Performance Management and by communicating information to employees and responding to their concerns.
• Ensures proper documentation practices are maintained consistently to company standards in manufacturing documents, training documentation, production logs and so on.
• Generates reports for deviations, assists in the investigations, and commends/implements solutions to resolve deviations. Approves deviation investigations as appropriate. Responds to product defect notifications.
• Authors, reviews, and approves Standard Operating Procedures and other documents to ensure integration of cGMPs and improve process efficiencies.
• Promotes and encourages continuous improvement in efficiency, quality, production, and safety using team driven processes and key performance indicators and recognition and rewarding high performance.
• Collaborates with OE Engineers & PET Engineers to optimize process performance.
• Participates in the design, selection, installation and qualification of new equipment, facilities, and processes.
• Provides career development and performance management for direct reports.
• Works collaboratively within and across PETs to ensure flow of product, sharing of best practices and lean behaviors.
• Maintains presence across multiple shifts.
• Occasionally performs rolls for PET Lead when designated.
• Ability to work effectively in a team environment.
• Candidate should possess the ability to work in a changing/demanding environment

• 6pm - 6:30am
• 2/2/3 Schedule (12-Hour Rotating)

• Significant experience in GMP or regulated production environment
• Previous supervisory experience
• Knowledge of FDA cGMP’s
• Strong communication, coaching and leadership skills
• Problem solving skills
• Ability to delegate tasks and projects effectively

• Bachelor of Science in Engineering, Pharmacy, related Science or business.
• Experience working in a LEAN manufacturing environment
• Working knowledge of LDMS or Veeva, Microsoft applications, SAP.
• Training or experience in formulation, filling, validation, technology transfer, change control.
• Knowledge or previous experience with pharmaceutical manufacturing, aseptic filling preferred.
• Strong mechanical, troubleshooting, and problem‑solving abilities.
• Ability to direct and participate in cross‑functional teams
• Project management skills
• Experience in Technology Transfer in a GMP environment
• Ability to generate and interpret technical documents

The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations.

Sponsorship or support…