Training Specialist Supervisor

1 month ago

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

Iovance Biotherapeutics Inc is seeking a highly skilled Training Specialist Supervisor to join our team at the Iovance Cell Therapy Center (iCTC). As a key member of our Manufacturing Training Department, you will play a pivotal role in overseeing and executing training programs for our aseptic manufacturing team.

Key Responsibilities:

  • Oversee the daily implementation and continuous improvement of training programs for aseptic manufacturing personnel.
  • Schedule and coordinate day-to-day activities, ensuring conformance to the daily training schedule.
  • Ensure training materials are up-to-date, accurate, and aligned with current GMP regulations and company procedures.
  • Assist in evaluating the effectiveness of the Training Program and implement necessary improvements.
  • Maintain training records and documentation in compliance with regulatory requirements.
  • Implement process improvements across the training department, including training curriculum development, review, and improvement of designated training scripts; On the Job and Instructor Led Trainings (OJTs and ILTs).

Requirements:

  • Minimum bachelor's degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
  • Minimum of 5+ years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture.
  • A minimum of 1 year in a supervisory role or corresponding experience in people management.
  • Expert technical knowledge of aseptic processing in cleanroom environments.
  • Expert knowledge of and experience with in-lab skills training, including aseptic technique, cell culture processing, aseptic gowning, and qualification.
  • Ability to mentor and provide best practices to new employees, including Training Specialists.
  • Ability to build relationships quickly and credibly, providing consistent, excellent support to staff, with the ability to influence large teams within the manufacturing environment.
  • Ability to accurately and reproducibly perform arithmetic calculations, including decimals, percentages, and basic algebraic calculations.
  • Proactive, results-oriented, self-starter, demonstrating strong leadership skills and experience in a complex manufacturing environment.
  • Ability to deal with ambiguity – ready to change gears and plans quickly, with the need to manage constant change.
  • Ability to work successfully in a fast-paced team-oriented setting.
  • Quality mindset, familiar with 21 CFR Part 11, standard GxP best practices, and FDA regulations.
  • Excellent presentation skills, both written and oral.
  • Understands and complies with quality standards and requirements as documented.
  • Must have strong written and verbal communication and organizational skills.
  • Strong computer skills, problem-solving, and attention to detail.
  • Familiarity with data and sample management required (LIMS/MES).
  • Working knowledge within a Learning Management System (LMS).
  • Able to work independently with minimal supervision.

Preferred Qualifications:

  • Experience with cell and gene therapy.
  • Experience with MasterControl.

Work Environment:

  • This position will work in both an office environment and a manufacturing laboratory setting.
  • Must be able to work in a laboratory setting with various chemical/biochemical exposures, including latex and bleach.
  • Ability to work in cleanroom with biohazards, human blood components, and chemicals.
  • Potential exposure to equipment hazards and strong odor.
  • Must be able to work in an environment with variable noise levels.

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