Manufacturing Operations Coordinator

US-GA-Union City
Job ID
2017-1056
Category
Manufacturing

Overview

Dendreon is in need of a Manufacturing Operations Coordinator with biopharmaceutical experience, 2 - 4 years’ experience with operations management in a finite scheduling environment, plus 2 - 4 years GMP experience. This position develops final product schedules in support of clinical and commercial manufacturing, and ensures that finite processing schedules adhere to the business needs/goals. This may include IB exp., OB expiration, Disposition/QC testing time, etc. This person needs to have an understanding of cGMP, GDP, and general aspects of an aseptic manufacturing environment.

 

Dendreon is an EEO/AA employer M/F/D/V.

Responsibilities

  • Ensures schedule adherence and recommends alternatives to scheduling exceptions.
  • Monitors receiving, manufacturing, and shipping to meet the agreed upon schedule.
  • Provides communication to affected departments of schedule changes in a timely fashion.
  • Communicates to adjacent shifts changes and events which may affect the finite schedule.
  • Organizes future activities (APVs, resource closures, training, etc.) which may impact the finite schedule.
  • Maintains plant resource calendars to support corporate scheduling staff in creating final production schedules and to ensure processing takes place in approved/released production areas. Interfaces with corporate customer service (Dendreon Connect, Med Info, etc), Operations, and Quality to prioritize production activities and other potential schedule interruptions. Adheres to the internal business processes/guidelines with regard to planning, prioritization and communication.
  • Maintains proficiency in operational areas and participates in processing as needed.
  • May provide direction to Manufacturing Operations Associates as needed.
  • Monitors, audits, and resolves manufacturing operations issues on and off the floor.
  • Monitors and prepares manufacturing operations records.
  • Responsible for ensuring production documentation is accurate and in compliance with all regulations and procedures.
  • Responsible for handling departmental documentation, investigations, impact assessments, and technical guidance.
  • Monitors, complies, and reports production metrics.
  • May also be responsible for other projects or tasks assigned by management.
  • Uses professional concepts and company policies and procedures to solve a variety of problems.
  • Exercises judgment and initiative within defined procedures and practices to determine appropriate action.
  • Has an understanding of cGMP, GDP, and general aspects of an aseptic manufacturing environment. 
  • Adapts well to a changing environment, is recognized as a team player internally and externally and provides strong customer service to the plant.
  • Uses ability as an experienced specialist to contribute to the development of concepts and techniques, and to complete tasks in creative and effective ways.
  • May be asked to perform other duties as assigned.
  • This job is performed in a lab, office, or utility (noisy) environment.

Qualifications

  • Bachelor’s degree or commensurate experience required.
  • 2 - 4 years’ experience with operations management in a finite scheduling environment.
  • 2 - 4 years GMP 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.
  • Ability to lift up to 25 pounds. Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas. 
  • Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50 lbs.
  • May be required to work alternate shifts.
  • 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.

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