Production Director

1/26/22

Princeton, NJ

1571

Production Director

Prepare operation schedules, supervises, and coordinates manufacturing activities to ensure sterile injectable products are manufactured in accordance with Standard Operating Procedures, current Good Manufacturing Practices and Safety Policies

Responsibilities

  • Prepare operation schedules and ensures production staffing is adequate to support the production schedule.
  • Review Manufacturing Batch Records for registration and commercial products. Review and approve executed batch records for completeness.
  • Review documentation, including batch records, logbooks, cleaning records, etc., for accuracy and completion.
  • Supervise compounding and filling line to ensure sterile injectable products are manufactured in accordance with Standard Operating Procedures, current Good Manufacturing Practices and Safety Policies
  • Is responsible for managing and coordinating all activities during production.
  • Is responsible for all safety incidents and quality deviations that occur during manufacturing and responsible for the thorough investigation and timely reporting of such.
  • Troubleshoot production problems, document findings, and implement solutions while providing all information to Management for risk assessment
  • Complete tasks, as assigned, in a timely manner
  • Support Pilot Test Runs, Validation Runs, Engineering Runs and other requirements needed
  • Support product development group in activities required to support the introduction of new products.
  • Collaborate with cross-functional leaders to support continuous improvement initiatives to drive operational excellence and maximize efficiency
  • Organize and improve material storage and flow to eliminate losses and improve efficiencies
  • Clearly communicates with subordinates and superiors any directions, issues, etc.
  • Hires, trains, evaluate and disciplines personnel. Maintain training programs in compliance.
  • Lead, coach and motivate manufacturing team
  • Complete other duties and tasks as assigned

Requirements

  • Bachelors or Master degree in chemistry, biology, pharmacy, engineering or other scientific discipline or related field
  • 5+ years commercial pharmaceutical manufacturing experience. At least 3 years in a supervisory/management capacity.
  • Strong problem solving and analysis skill
  • Attention to details and a strong focus on quality and safety
  • Ability to coach, mentor and train employees
  • Thorough knowledge of machinery processes in an aseptic manufacturing environment.
  • Thorough understanding of Standard Operating Procedures and current Good Manufacturing Practices.
  • Knowledge of accepted practices and regulatory requirements associated with safety and protection of workers, environment and site
  • Knowledge of technologies and applications used in manufacturing products and in the optimization of manufacturing processes
  • Excellent time management for self and team
  • Experience and knowledge of HVAC systems, clean rooms, sanitary processing, sterilization equipment, and WFI systems, computer control systems, cleaning processes and aseptic manufacturing
  • Be able to work efficiently and handle multiple task simultaneously
  • Has excellent communication skills (both oral and written).

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