Manager, Quality Control Laboratory Potency Assays - Philadelphia, United States - Iovance Biotherapeutics Inc

Description

Job Description

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.

Overview

The Quality Control Laboratory Manager, Potency Assays will manage quality control testing operations for cell-based potency assays at Iovance's integrated Cell Therapy Center (iCTC). The QC Analytics testing operations include, but are not limited to, in-process and final drug product, and stability testing for clinical and commercial lots. The role requires solid knowledge and a functional understanding, including hand-on testing, in the following areas: cell maintenance and cell count determination (NC-200) and cell-based potency assays using various immunoassays (ELISA, etc.) with a focus on cell therapy products. This position supports the ramp-up of QC Analytical release assays and other activities in a newly built facility for cell therapy products.

This role will apply appropriate cGMPs and regulatory requirements in the product development life cycle, including, but not limited to, lot release and stability testing, method qualification and validation, method technology transfers, and writing/review of QC procedures. The Quality Control Laboratory Manager, Potency Assays role will have direct oversight of the QC Supervisors and analysts and assay performance. Overtime, weekends, and holiday work may be required to meet target turn-around times for product release.

Essential Functions and Responsibilities

• All duties are performed independently with minimal supervision and oversight.
• Act as technical subject matter expert (SME) for potency testing and related activities.
• Responsible for the scheduling and timely execution of potency testing and related activities and the respective data review and release.
• Manage the day-to-day GMP QC Potency testing activities at the iCTC facility including quality control testing and support testing for cell therapy intermediates, final product, and stability testing.
• To ensure target turn-around times are met, may be required to assist in execution of assays.
• Ensure that QC staff are appropriately trained and are performing tests in accordance with method procedures and are consistent with implementing the required techniques.
• Responsible for data analysis and final result reporting to support product lot release with adherence to turnaround times.
• Ensure that the daily GMP quality control laboratory testing activities at the iCTC facility are executed with minimal to no errors and ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
• Lead/Support thorough GMP investigations for out of specification test results, corrective actions, and verification of effectiveness, and other quality events.
• Provide technical problem solving for issues pertaining to GMP quality control.
• Support product stability programs including timely scheduling of stability testing, stability data analysis, and final reporting of stability data.
• Responsible for the generation/revision and/or review of documentation, such as SOPs, protocols and reports, especially for potency assays.
• Responsible for ensuring timely review of laboratory data and logbooks in the potency laboratory space.
• Support LIMS initiative.
• Ensure trending of analytical performance is performed, as required.
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.
• Support Health Authority inspections.
• Organize and conduct Tier 1 and other QC-related meetings.
• Successfully interface and provide input with multi-disciplined teams.
• Ability to effectively manage multiple priorities involving dynamic and aggressive timelines at a high level of productivity.
• Other responsibilities, as assigned.

Education and Qualifications

• Minimum of a Bachelor's degree in Biology, Biochemistry, or related scientific field.
• Six (6) to eight (8) years of experience in the pharmaceutical industry within a Quality Control role with increasing project and management responsibilities; experience with cell therapy products is a plus.
• Solid understanding and functional knowledge with hands-on experience with the following: Cell Based Potency Assays and supporting ELISA platforms and cell maintenance (primary cells and continuous cell lines) and cell count determination (NC 200)
• In-depth knowledge of ICH/USP/EMA guidelines in a GMP QC setting.
• Experience in managing and leading a team of scientific personnel.
• Highly proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.)
• Experience in authoring quality documents (e.g., deviations, change controls, CAPAs, investigations, etc.)
• Experience with laboratory information management systems, i.e., LabVantage LIMS.
• Successfully interface with multi-disciplined teams.
• Extremely detail-oriented with strong technical skills.
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
• High level of ownership and accountability.
• Demonstrate sense of urgency; ability to recognize time sensitivity.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)

Preferred Education, Skills, and Knowledge

• Advanced degree (MSc., Ph.D.) in Biology, Biochemistry, or related scientific field is preferred.
• Experience with cell therapy products is a plus.
• Experience with multi-color flow cytometry assays is a plus.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation 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 clean room 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.
• Must be able to use near vision to view samples at close range.
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 30 pounds.

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, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers.

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

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