Manufacturing Operations Supervisor

US-CA-Seal Beach
Job ID
2017-1035
Category
Manufacturing

Overview

Dendreon is looking for a Manufacturing Operations Supervisor with 3-5 years cGMP experience, and biopharmaceutical experience. This position will report to the Manufacturing Operations Manager, and is responsible for overseeing the planning and monitoring of manufacturing process activities and works closely with plant personnel to ensure the execution of production activities per the master treatment schedule. There will be limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas.

 

This person also needs to have 5-7 years related experience with operations management in a finite scheduling environment. This job is performed in a lab, office, or utility (noisy) environment.

 

May be required to work alternate shifts.

Responsibilities

  • Supervises MFG Ops personnel and ensures all staff are trained to support the operations, planning and execution process.
  • Provides daily supervision of operations to develop and maintain final product schedules in support of clinical and commercial manufacturing. 
  • Monitors and tracks manufacturing process activities to ensure proper execution of production schedules. 
  • Ensures plant resource calendars are maintained and internal SOPs and guidelines are adhered to when removing or re-instating a resource in the scheduling system. 
  • Manages exceptions with regard to planning and execution and is responsible for issue escalation and resolution per the internal guidelines.
  • Oversees the creation and management of daily coordination meetings with all cross functional teams.
  • Develops and maintains SOPs, work instructions, and internal business guidelines required to support the business processes and goals. 
  • Assists in the development and maintenance of capacity planning models and long-range production schedules.
  • Represents department in cross-functional teams and projects. 
  • Selects, develops and evaluates personnel to ensure functional objectives are met.
  • Provides management with business intelligence and reports for key business performance indicators.
  • Uses professional concepts and company policies and procedures to solve a variety of problems.
  • Exercises judgment within defined procedures and practices to determine appropriate action.
  • Does not require general instructions on routine work, detailed instructions are only provided on new assignments.
  • Strong understanding for the end to end process and is able to discern priorities, escalate issues and manage exceptions.
  • Works on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations
  • Adapts well to a changing environment, is recognized as a team player internally and externally and provides strong customer service to the plant.
  • Strong ability to plan work, assign work, measure work, coach and motivate.
  • Ensures self and team are always current with new/changing information/guidance and supports the MFG ops manager in day to day activities.

Qualifications

  • Bachelor’s degree, higher education preferred.
  • Typically 5-7 years related experience with operations management in a finite scheduling environment.
  • 3-5 years cGMP experience, biopharmaceutical experience preferred. 
  • Proficient in MS Office applications. 
  • Ability to sit or stand for extended periods of time.
  • Intermittent walking to gain access to work areas.
  • Finger dexterity sufficient to use a computer and to complete paperwork activities.
  • Vision sufficient to use a computer, to read written materials and to complete paperwork activities.
  • Hearing sufficient to communicate with individuals by telephone and in person.
  • Must have the ability to regularly lift 10 – 20 lbs and lift up to 50 lbs.
  • Ability to gown aseptically for work in Clean Room environments.
  • Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials. 
  • Does not require general instructions on routine work, detailed instructions are only provided on new assignments.
  • Strong understanding for the end to end process and is able to discern priorities, escalate issues and manage exceptions.
  • Demonstrates strong verbal and written communications skills and the ability to negotiate with internal and external customers.
  • Adapts well to a changing environment, is recognized as a team player internally and externally and provides strong customer service to the plant.

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