Supervisor, Quality Operations

• The successful candidate will also help onboard new team members and manage deviations, CAPAs, and change controls.
• This individual will

About Iovance Biotherapeutics

Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics, Inc.

is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors.

Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers.

The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches.

As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year.

For more information, please visit www.iovance.com

Amtagvi® and its accompanying design marks, Proleukin, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.

Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com uality

Responsibilities

• Operations who has operational experience in Quality clean room activities and can provide QA oversight for manufacturing activities at the iCTC
• be responsible for
• supporting day-to-day Q

uality

• Operations activities relating to support manufacturing and release of products manufactured at the iCTC. The individual will be collaborative, organized, innovative, flexible, with a strong desire to learn and take ownership and accountability.
• Supervision and Development direct reports, mentoring/coaching to motivate and mentor peers/staff to foster a culture of continuous improvement, quality, and excellence.
• Perform real-time, on-the-floor support for escalations to ensure compliance with GMP and GDP quality initiatives.
• Schedule and coordinate daily activities ensuring conforman ce to the daily schedule.
• Apply quality compliance theories and principles to independently address a variety of issues of moderate scope. Provide guidance on controlled documents (content, quality, and document lifecycle), identifying gaps, addressing documentation needs, and suggesting process improvements.
• Helps to ensure compliance to cGMPs and facility procedures. Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations, and other observations) and escalate if not resolved as appropriate to management.
• Review batch records and related production documentation, ensuring resolution of all identified issues prior product disposition. Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies, and observations to management.
• Support release of drug product and materials during the shift
• Issuance of lot numbers and supporting documentation as needed for the shift.
• Initiate and participate in standard operating procedure (SOP) revisions to improve compliance.
• Review of Quality System records for compliance.
• cleanroom
• with
• biohazards,
• human

blood

• components,
• Biotherapeutics’ core values, policies, procedures, and business ethics.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.

Requirements

• B.S. in biology, biochemistry, bioengineering, related technical field, or equivalent industry and technical experience.
• Minimum of 5 years of experience in biopharmaceutical-based GMP aseptic manufacturing.
• A minimum of 2 years in a Lead/Leadership/Supervisory Role is desired
• Detailed knowledge of Code of Federal Regulations 21 CFR 210/211 and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals; 21 CFR 1271 is a plus
• Excellent oral and written communication skills

Ability to

• and resolve quality issues with others in a proactive, diplomatic, flexible, and constructive manner
• Must be comfortable in a fast-paced environment and changing priorities
• Experience with use of an electronic QMS, MasterControl
• Must be able to work in a cleanroom lab

and

• chemicals
• Must adhere to

Preferred Education, Skills, and Knowledge

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.

For the Visual Inspection Program, the technician must be able to pass a Vision Exam that includes the following:

Must not be color blind.

Must have 20/20 near vision in both eyes (can be corrected)

Physical Demands and Activities Required

Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.