Training Specialist Supervisor

Job Description

Job Description

Salary : Overview

Overview

Iovance is an immune-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL).

The company’s lead candidate is an autologous, ready-to-infuse cell therapy, that has demonstrated distinctive efficacy in the treatment of metastatic melanoma.

The company has a commercially approved product along with multiple on- going clinical trials in various phases for squamous cell carcinoma of the head and neck, cervical carcinoma, non-small cell lung cancer, and immunotherapy for solid tumors.

The company is currently developing its commercial manufacturing capacity to support development and launch of these assets.

The Training Specialist Supervisor will oversee Training Specialists within the Manufacturing Training Department at Iovance Cell Therapy Center (iCTC).

This position will play a pivotal role in overseeing and executing training programs for the aseptic manufacturing team.

This individual will ensure that all manufacturing personnel are equipped with the necessary knowledge and technical skills to perform their duties in compliance with GMP regulations and company standards.

This role requires a strong background in cell culture, aseptic technique and processing, aseptic gowning and GMP manufacturing, coupled with the ability to lead and mentor a team of training specialists.

Essential Functions and Responsibilities :

Training Program Oversight :

• Oversee the daily implementation and continuous improvement of training programs for aseptic manufacturing personnel.
• Scheduling and coordination of day-to-day activities, ensuring conformance to the daily
• 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
• Maintain training records and documentation in compliance with regulatory
• Implements 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).

Team Leadership :

• Supervise and mentor a team of Training Specialists, providing guidance and support
• Conduct performance evaluations and provide feedback for professional development
• Foster a collaborative and positive team environment
• Mentors new Training Specialists during onboarding / qualification process
• May lead a training program subset for internal or external groups

Training Delivery :

• Presents and delivers training content to manufacturing technicians; includes additional trainees outside of manufacturing department or external vendors.
• Assess trainee competency and provide feedback

Subject Matter Expertise :

Demonstrates an advanced understanding of the current cell therapy manufacturing process, scientific background and the equipment utilized during processing.

This role is viewed as a subject matter expert (SME) for both OJTs and ILTs.

Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).

Completes recording of data to comply with regulatory requirements.

• Stay abreast of industry trends and regulatory changes
• Provide technical guidance and support to the Manufacturing Team

Operational Support :

• Assist in the development and revision of SOPs
• Participates in investigations and CAPAs related to training and manufacturing deviations
• Appropriately escalates issues / concerns to Area Management for further investigation
• Ability to work in a team environment or independently, as needed. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.

General :

• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures and business ethics.
• Complies with Safety SOPs, SDS sheets and laboratory procedures per company policy and OSHA regulations.
• Performs miscellaneous duties as assigned

Required Education, Skills and Knowledge :

• 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.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Expert technical knowledge of aseptic processing in cleanroom environments is a must.
• Expert knowledge of and experience with in-lab skills training, including aseptic technique, cell culture processing, aseptic gowning and qualification is a must.
• Experience leading development initiatives such as training, coaching / mentoring, learning initiatives
• Ability to mentor and provide best practices to new employees, including Training Specialist
• Ability to build relationships quickly and credibly, providing consistent, excellent support to staff, with the ability to influence large teams within the manufacturing environment, representing a variety of personalities and experience levels.
• 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 deails
• Familiarity with data and sample management required (LIMS / MES).
• Working knowledge within a Learning Management System (LMS).
• Able to work independently with minimal supervision
• This position is for regular work week hours (M-F).
• Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).

Preferred Education, Skills and Knowledge :

• Experience with cell and gene therapy preferred
• Experience with MasterControl prefered

Physical Demands and Activities Required :

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully.

Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

• Must be able to wear appropriate cleanroom attire and all required Personal Protective Equipment (PPE) within the cleanroom.
• i.e. Scrubs, gowning coveralls, masks, gloves, safety goggles, etc.
• Must meet the requirements for and be able to wear a half-face respirator
• Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors; may be given a visual exam for visual acuity and color perception.
• Ability to stand and / or walk 90% (and sit 10%) within a scheduled workday
• Ability to crouch, bend, twist, reach and perform activities and repetitive motions
• Must able to lift and carry objects weighing 25 pounds.

Mental :

• Clear and conceptual thinking ability; excellent judgement, 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 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 environment with variable noise levels.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description.

They are not intended to constitute a comprehensive list of functions, duties, or local variances. Managements retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-

opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

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