Training Specialist I

1 day ago


Philadelphia, Pennsylvania, United States Planet Pharma Full time
Job Description:

The Training Specialist I will be a key member of the Planet Pharma team, responsible for delivering high-quality training programs to manufacturing technicians in the autologous cell therapy manufacturing program.

Key Responsibilities:

  • Develop and deliver comprehensive training programs to ensure manufacturing technicians have the necessary skills and knowledge to perform their duties safely and effectively.
  • Collaborate with subject matter experts to develop and maintain training materials, including SOPs, batch records, and deviation reports.
  • Conduct regular training sessions, including instructor-led training and on-the-job training, to ensure technicians are proficient in their roles.
  • Assist with the creation and review of training scripts, ensuring they are accurate, up-to-date, and compliant with regulatory requirements.
  • Support the management team in aligning manufacturing processes with technical training, ensuring consistency and quality.
  • Identify training needs and assist in establishing a feedback loop to ensure continuous improvement.
  • Perform miscellaneous duties as assigned, including drafting SOPs, batch records, and deviation reports.

Requirements:

  • Minimum bachelor's degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
  • Minimum of 2 years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture.
  • Technical knowledge of aseptic processing in cleanroom environments and experience leading training initiatives.
  • Ability to mentor and provide best practices to new employees, build relationships quickly, and provide consistent support to staff.
  • Excellent presentation skills, both written and verbal, and ability to work successfully in a fast-paced team-oriented setting.
  • Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.

Work Environment:

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


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