Manager, Quality Assurance Operations iPBMCs

Overview

Iovance Biotherapeutics is a growing company focused on the development and commercialization of immunotherapies based on TIL (Tumor Infiltrating Lymphocytes). The Quality Assurance (QA) Operations Manager position will be integral to providing QA oversight of CMOs (Contract Manufacturing Organizations) for critical materials. The position will help co-ordinate daily quality-related operations between Iovance and CMOs and is responsible for supporting day-to-day GMP QA Operations activities that support manufacturing, testing and release of iPBMCs in a GMP compliant manner. The individual is collaborative, organized, innovative, flexible, with a strong desire to learn and take ownership and accountability.

The position can be based in Philadelphia, PA or can be remote. The position will report to the Director of Quality Assurance Operations.

Essential Functions and Responsibilities

• Establish direct lines of communication with the CMO QA, Manufacturing, and QC functions.
• Ensure knowledge and information between the CMO and Iovance are shared in a timely manner.
• Ensure that day -to-day activities for QA Operations and lot disposition are efficient, coordinated, and executed as planned.
• Ensure efficient operations, and compliance with quality standards, cGMPs, safety regulations, and requirements as documented.
• Actively interact with Contract Manufacturing Organizations (CMO), and internal teams to ensure efficient and timely batch release.
• Contribute to strategic and tactical decisions based on sound Quality principles and available data. Provide quality direction to, and gain alignment across, functions who are problem solving.
• Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of the operation.
• Perform review and approval of release documentation.
• Identify, propose, and implement procedural changes to improve controls and product quality.
• Continuously evaluate CMO performance. Identify and implement corrective actions as needed.
• Lead or participate in investigations for nonconforming events.
• Support batch record review and release.
• Evaluate procedures and practices to ensure inspections readiness.
• Report on CMO performance for overall site metrics and key issues at Iovance Quality Review meetings.
• Provide support for internal audits, Iovance audits of CMO, and regulatory inspections of CMO
• Other duties as assigned.

Team Leadership:

  •         Supervision and Development of direct reports, mentoring/coaching to motivate and mentor peers/ staff, to foster a culture of continuous improvement and operational excellence.

 •         Ensure that QA staff are adequately organized, supervised, and staffed. Intervene, where necessary, to expedite decision making or to meet target timelines.

 •         Establish objectives and conduct performance reviews, monitoring progress toward objectives and provide timely feedback to Management.

 •         Ability to work under limited supervision and to handle problems of a more difficult nature.  

Required Education, Skills, and Knowledge

·       BS degree in life sciences. Advanced degree a plus.

·       At least 10 years of Quality experience in a GMP environment, with experience in contract manufacturing.

·       Experience in biologic or cell therapy manufacturing is required

·       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 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 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.

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