Drug Product Operations Coordinator

Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: September 24, 2022

Job Description:

Overview The Drug Product Operations Coordinator assists the Drug Product Manufacturing team to ensure Right-First-Time execution on the GMP manufacturing floor by developing and driving systems for readiness, compliance, and performance of new knowledge. - The Drug Product Operations Coordinator will assist in supporting the timely release and disposition of drug product batches and other post-execution activities. External US Essential Functions:Responsible for participating in the following activities within the Drug Product Operations function: - - - Compliance

• Assist the Drug Product Manufacturing team, the Drug Product Manufacturing Supervisor/Manager, subject matter expert(s), and quality teams to resolve deviations and track closures of any associated corrective actions.
• May assist with authoring, reviewing, and approving batch records, SOP's and Work Instructions for both original and periodic updates.
• Assists manufacturing in preparing and driving the approval of material specification documents. - - - Equipment and Readiness Coordination
  • Works with manufacturing to coordinate or execute water runs and/or aseptic process simulations.
  • Works with validation to coordinate qualifications and re-qualifications associated with acquisition of new equipment.
  • Assists in preparing User Requirement Specifications as needed for new equipment.
  • Work with manufacturing lead in harmonizing best readiness practices between sites.
  • Works with manufacturing and supply chain to follow-up on material ordering and receipt for GMP manufacturing.
  • Originates and tracks manufacturing work orders as necessary. - - Continuous Learning and Improvments
    • Participate in team projects relating to Operational Excellence.
    • Assists manufacturing lead and management to see what AAR lessons and room walk-through observations can be converted into guidebooks to establish and spread best practices to other functions within manufacturing.
    • Participates in team projects relating to Operational Excellence such as Problem Analysis and Prevention.
    • Assists team in creating guidebooks to proceduralize workflows within manufacturing and cross-functional flows and trains Manufacturing personnel on their use. - - - Right-First-Time (RFT) Execution
      • Coordinates or may lead Pre-Run Readiness activities within manufacturing.
      • Works with technical support personnel to gather post-execution data.
      • -
      • Performs all other duties as assigned.Required Skills & Abilities:
        • Good oral and written communication skills, interpersonal and organizational skills.
        • Practical understanding of equipment used in drug product operations
        • Proficient with Microsoft Office applications
        • Good self-discipline and attention to detail
        • Must have flexible work hours - must be willing to work outside of normally scheduled hours as necessary; including opportunities for alternative shift hours and weekends as required.
        • Experience working in cleanroom environments under sterile or aseptic conditions
        • Must have good planning skills and must be willing to interface with and guide colleagues in many different roles and functions throughout the manufacturing facilities.Working Conditions & Physical Requirements:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. - Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. - While performing the duties of this job, the employee is required on a regular basis to:
          • Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching.
          • Use hand-eye coordination and manual dexterity sufficient to operate in a laboratory and/or manufacturing environment.
          • Ability to lift up to 25 pounds; frequently, and up to 50 pounds; on occasion.
          • Attendance is mandatory.Qualifications:
            • Bachelor's degree preferably in Science, Engineering, or other related field and with two (2) years' experience preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain experience; OR
            • Associate's degree preferably in Science, Engineering, or other related field and with five (5) years' experience preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain experience; OR
            • High School Diploma and seven (7) years' experience preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain experience
            • Above experience must include one (1) year GMP experience.Preferred Qualifications:
              • Experience working with aseptic filling operations
              • Experience working with isolator technology
              • Experience working with Vanrx SA25

Keywords: FDBT - FUJIFILM Diosynth, College Station , Drug Product Operations Coordinator, Other , College Station, Texas