Manufacturing Operations Coordinator

2 weeks ago


Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time
Job Summary

We are seeking a highly skilled Manufacturing Operations Coordinator to join our team at Iovance Biotherapeutics Inc. This role will be responsible for coordinating and managing the day-to-day operations of our GMP cell therapy manufacturing process.

Key Responsibilities
  • Develop and maintain a subject matter expert-level understanding of our manufacturing process to ensure accurate scheduling and forecasting.
  • Assist management in tracking and maintaining operator trainings and qualifications to ensure operational capacity.
  • Manage meetings with cross-functional teams to discuss manufacturing departmental needs.
  • Track and report key performance indicators related to scheduling adherence, personnel utilization, and capacity.
  • Coordinate with cross-functional teams to ensure all necessary documents, materials, equipment, and facility workstations/rooms are available to support operations.
  • Track and report statuses of deviations, CAPAs, change control requests, and related documentation updates.
  • Ensure manufacturing schedules are aligned with training schedules and coordinate necessary trainings for manufacturing personnel.
  • Support interdepartmental projects and technical transfer activities as needed.
Requirements
  • Bachelor's degree or equivalent experience in a related field.
  • Ability to collaborate with multiple departments and assess individual needs against business needs.
  • Strong analytical and problem-solving skills with ability to handle ambiguity and change.
  • Excellent communication and interpersonal skills with ability to build relationships quickly.
  • Proficient in Microsoft Office applications, including Excel, Word, PowerPoint, and Outlook.
Preferred Qualifications
  • Minimum 3+ years of experience in biopharmaceutical-based GMP manufacturing operations.
  • Quality mindset with knowledge of 21 CFR Part 11 and standard GxP best practices.
  • Proactive and results-oriented with experience in a complex manufacturing environment.
Work Environment

This role will work in both an office and manufacturing setting. The candidate must be able to work in a lab setting with various chemical and biochemical exposures, including latex and bleach. Potential exposure to noise and equipment hazards and strong odors.



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