Technical Learning Specialist I, GMP Training Administration

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview 

Iovance is seeking a highly motivated individual for the position of GMP Training Administration Specialist I at Iovance’s Cell Therapy Center (iCTC) in Philadelphia PA. This position is responsible for supporting the Technical Learning program and ensuring training is implemented in an effective manner at the site. In addition, this position will be responsible for providing training and guidance to users on Iovance’s electronic Learning Management System (LMS).

Essential Functions and Responsibilities 

• Supports the right first time review of training documentation in the LMS, where necessary.
• Provides accurate ad hoc and scheduled training reports and other metrics reports from the LMS for functional groups and/or department leadership.
• Maintain accurate qualification training records for site personnel in the LMS
• Review Training Qualification Forms and make simple decisions about approval, rejection, and implementation of the forms.
• Administer and assign training in the LMS; including successful, accurate creation of new LMS infrastructure (courses, job codes, etc.).
• Support new hire onboarding, including the assignment of training in the LMS and new hire orientation.
• Support the completion of training checkpoints for new and revised documents, making simple decisions about training assignment with cross-functional guidance.
• Provide LMS End User Support and troubleshoot simple problems within the LMS
• Work with cross-functional teams to develop competency and department-specific curricula
• Able to fully navigate the LMS independently.
• Supports training implementation in response to quality events.
• Deliver training sessions when applicable, and ensure training documentation is maintained. Ensure training schedules meet company production and quality targets.
• Assists functional groups with the creation or improvement of training content for established processes.
• Support projects for new methodologies for the implementation of the LMS.
• Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of training.
• Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
• General knowledge of industry training standards and requirements.
• Attends meetings and escalates issues/concerns at that forum to Area Management for further investigation.
• May work on training-related projects that are simple to moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting site efforts.
• Able to lead meetings with area owners to drive training-related projects to closure.
• Ability to work in a team environment and independently as required. 
• Contribute to department operations improvement in areas such as SOP revisions and department inspections.
• Other duties as assigned. 

Required Education, Skills, and Knowledge

• Bachelor’s degree (Life Sciences preferred) and a minimum of 2 years of experience in training and documentation in pharmaceutical or biopharmaceutical GMP based facility; or an advanced degree without experience; or equivalent work experience.
• Familiar with document change management and FDA quality systems
• Familiar with an LMS/DMS system (MasterControl is a plus)
• Right first-time mentality
• Strong skills in Good Documentation Practices and Data Integrity
• Must possess a high-level of attention to detail and proficiency in Word and Excel
• Strong computer, organizational, and compliance skills
• Ability to work effectively on multiple projects simultaneously with minimum supervision. 
• Strong interpersonal and communication skills

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. 

Physical Demands and Activities Required 

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers. 
• Must be able to communicate with others to exchange information. 

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible. Requires operating standard office equipment and keyboards.

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