Training Coordinator

Overview

Iovance Biotherapeutics is an immunooncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL). The companys lead candidate is an autologous readytoinfuse cell therapy that has demonstrated distinctive efficacy in the treatment of metastatic melanoma. The company has Phase 2 clinical trials in progress for squamous cell carcinoma of the head and neck cervical carcinoma nonsmall cell lung cancer and immunotherapy for solid tumors. The company currently is developing its clinical and commercial manufacturing capacity to support the development and launch of these assets.

As this person will be a key member of the autologous cell therapy manufacturing program a background in cell culture aseptic gowning and qualification and ISO class 5 cleanroom operations is strongly preferred.

Essential Functions andResponsibilities:

• Develop a Subject Matter Expert (SME)level understanding of training needs to create accurate scheduling forecasts and training schedule for Iovances Manufacturing Training Department.
• Develop a platform to assist management with tracking maintaining and scheduling Manufacturing new hire trainings and qualifications weekly.
• Track and report key performance indicators associated with scheduling adherence personnel utilization and training capacity.
• Ensure all documents materials equipment and facility workstations/rooms are available as needed to support training operations.
• Create Training Binders for incoming MFG New Hires.
• Support the Training segment of Iovances New Hire Orientation; roll out of MFG syllabus to new hires.
• Support interdepartmental projects in a contributor capacity.
• Support departmental projects in a contributor capacity; support with continuous improvement projects.
• Assists with identification of training needs establishing a feedback loop to ensure continuous improvement.
• May work on assignments that are moderately complex in nature where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
• Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs) including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
• Attend departmental meetings and escalate issues/concerns at that forum to Area Management for further investigation; contribute to weekly Team meetings.
• Ability to work in a team environment and independently as required. Works on routine assignments per written procedures where ability to recognize deviation from accepted practice is required.
• Other duties as assigned.

Required Education Skills and Knowledge

• Bachelors degree in relevant field.
• Ability to collaborate with multiple departments and assess departmental needs against business needs.
• Must be able deal with ambiguity ready to change gears and plans quickly able to manage constant change.
• Must be able to read write and understand English especially for Good Documentation Practices and be proficient in Microsoft (Excel Word PowerPoint Outlook).
• Ability to build relationships quickly and credibly.
• Ability to work successfully in a fastpaced teamoriented environment.
• Must adhere to Iovance Biotherapeutics core values policies procedures and business ethics.
• Experience with learning management systems (LMS) or training databases.
• Must have strong project coordination organization and communication skills.

Preferred Qualifications:

• Minimum 3 years of experience in biopharmaceuticalbased GMP manufacturing operations experience in cell culture and associated downstream processing a plus.
• Quality mindset familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Proactive results oriented selfstarter with experience in a complex manufacturing environment.

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.

Physical Demands and Activities Required:

• Ability to stand/sit/walk for long periods of time.
• Ability to crouch bend twist reach and perform activities with repetitive motions.

Mental:

• Clear and conceptual thinking ability; excellent judgment troubleshooting problemsolving analysis and discretion; ability to handle workrelated stress; ability to handle multiple priorities simultaneously; and ability to meet deadline

Work Environment:

• This position will work in an office setting.

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. Management 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 equalopportunity employer our employees and applicants will be considered without regard to an individuals 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. If you need assistance or accommodation to apply to one of our opportunities please contact .

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