Manufacturing Coordinator

Overview

Iovance Biotherapeutics is an immuno-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 Phase 2 clinical trials in progress for squamous cell carcinoma of the head and neck, cervical carcinoma, non-small cell lung cancer, and immunotherapy for solid tumors.  The company currently is developing its clinical and commercial manufacturing capacity to support 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 desired.  

Essential Functions and Responsibilities

• Develop a Subject Matter Expert (SME)-level understanding of day-to-day processing needs to develop accurate scheduling forecasts and scheduled for Iovance’s GMP cell therapy manufacturing process(es).
• Assist management in tracking, maintaining, and scheduling operator trainings and qualifications to maintain operations capacity.
• Manage meetings focused on manufacturing departmental needs, collaborating with management and cross functional groups.
• Track and report key performance indicators associated to scheduling adherence, personnel utilization, and capacity.
• Track manufacturing readiness, and coordinate with cross-functional team to ensure all documents, materials, equipment, and facility workstations/rooms are available as needed to support operations.
• Track and report statuses of deviations, CAPAs, change control requests, and related documentation updates to ensure teams are aware of key deadlines.
• Ensure manufacturing schedule is aligned with training schedule as required, and works with training manager to coordinate necessary trainings for manufacturing personnel.
• Support interdepartmental projects in a contributor capacity.
• Supports technical transfer and additional research level testing activities, as needed.
• Perform basic revisions as needed to accurately reflect current procedures.
• Support departmental projects in a contributor capacity.
• 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 or hold the daily huddle meeting and escalates issues/concerns at that forum to Area Management for further investigation.
• 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  

• Bachelor's degree or some post-secondary education.
• Ability to collaborate with multiple departments and assess individual 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 fast-paced team-oriented environment.
• Must adhere to Iovance Biotherapeutics core values, policies, procedures and business ethics.

Preferred Qualifications

• Minimum 3+ years of experience in biopharmaceutical-based 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, self-starter with experience in a complex manufacturing environment.
• May require up to 5% travel, based on business need.

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.
• Ability to lift 20 lbs.
• Must be able to work in environment with variable noise levels.
• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.

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 deadline

Work Environment: 

• This position will work in both an office and a manufacturing setting.
• When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
• Potential exposure to noise and equipment hazards and strong odors.

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 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. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.  

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