Senior Manager, Quality Operations

Iovance is hosting an onsite Job Fair.

Where: Iovance Cell Therapy Center (iCTC)

Location: 300 Rouse Blvd Philadelphia, PA 19112

Date: Monday, June 24, 2024

Time: 12pm to 6pm (EDT)

What to bring: Updated resume

We are Hiring! We look forward to seeing you at the Job Fair.

This is an onsite role at our Philadelphia (ICTC) location.

Overview

Iovance Biotherapeutics is a growing company focused on the development and commercialization of immunotherapies based on tumor infiltrating lymphocytes (TIL). The Senior Manager, Quality Operations, is a newly created position that requires a highly independent individual with strong communication skills.

The position will help to represent the Quality organization in the oversight and monitoring of GMP production. The position will be a key point of contact for communications between manufacturing and Iovance Quality, with the goal of optimizing informed decision making. The position will be fluent in aseptic manufacturing processes and procedures.

Essential Functions and Responsibilities

• Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management.

• Lead the Quality Operations team, ensuring daily support for all manufacturing activities and escalations.

• Review batch records and related production documentation, ensuring resolution of all identified issues prior product Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies and observations to management.

• Disposition incoming raw materials

• Provide day-to day QA support for internal QC activities and escalations.

• Provide QA support for tech transfers, product method validation, verification and transfers to the lab in iCTC.

• Lead or provide strong support for investigation of deviations, nonconforming events, and corrective action/preventative action investigations

• Support batch record review and related production documentation, ensuring resolution of all identified issues prior product Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies and observations to management.

• Support of product release.

• 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

• Develop and establish SOPs for process improvements

• Identify, propose, and help implement procedural changes aimed at improving product quality

• Ensure knowledge sharing and collaborative troubleshooting

• Provide support for Iovance audits

• Other duties as assigned

Required Education, Skills, and Knowledge

• BS degree in science. Advanced degree a plus.

• Prior experience in QC specific to cell therapy.

• At least 8 years of Quality experience in a GMP environment, with experience in contract manufacturing.

• Excellent interpersonal, verbal and written communication skills are essential in this collaborative position.

• Experienced in troubleshooting, investigations, problem solving and in negotiating the path forward with multiple functions.

• Strong working knowledge of GMPs and Health Authority standards and expectations in both the US and Europe.

• Ability to simultaneously manage multiple projects and submissions

• Ability to follow through on all activities to ensure projects are completed as planned

• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.

• Able to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships.

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:

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

• Must meet requirements for and be able to wear a half-face respirator

• Able to stand and/or walk 90% (and sit 10%) of the scheduled workday, which may include climbing ladders or steps.

• Able to crouch, bend, twist, reach, and perform activities with repetitive motions

• Must be able to lift and carry objects weighing 45 pounds

Mental:

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

Work Environment:

• This position will work in both an office and a manufacturing lab setting

• When in the lab, must be able to work in a Lab setting with various chemical/biochemical exposures, including latex and bleach.

• Able to work in a cleanroom with biohazards, human blood components, and chemicals

• Potential exposure to noise and equipment hazards and strong odor

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 do not constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or change 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.

By voluntarily providing information and clicking "Submit Application", you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.

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