Supervisor, Quality Control

The Supervisor, Quality Control Analytics role will support the Quality Control (QC) Analytics programs and testing operations at Iovance’s integrated Cell Therapy Center (iCTC).

The QC Analytics testing operations include but are not limited to, in-process, final drug product, and stability testing for clinical and commercial lots.

This role requires hands-on experience in at least two of the following : cell maintenance and cell count determination (NC-200), cell-based potency using various immunoassays (ELISA, etc.

and / or identification / characterization / potency assays using multi-color flow cytometry platforms. 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 Supervisor, Quality Control Analytics role will have direct oversight of the QC analysts and performance. This position works across different shifts.

Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to meet target turn-around times.

Shift - Sunday - Thurs or Tuesday - Saturday

Essential Functions and Responsibilities

• All duties are performed independently with minimal supervision and oversight.
• Supervise the execution of all laboratory activities, including release testing and laboratory maintenance activities.
• Supervise the technical transfer, qualification, and validation of QC Analytical test methods for in-process materials, lot release, and / or stability, as needed.
• Perform daily GMP QC laboratory testing activities at the iCTC facility.
• Author, review, and approve SOPs, protocols, reports, specifications, and other QC documents.
• Ensure trending data input for all generated data is performed timely.
• Lead investigations for out-of-specification test results, corrective actions, and verification of effectiveness.
• Support product stability programs including generation of stability protocols, execution of stability testing, and transfer of stability results to external QC.
• Ensure that the daily GMP QC 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.
• Increase breadth of technical abilities through qualification on all QC analytical release assays.
• Serve as a qualified trainer on all QC analytical release assays, as needed.
• Serve as a qualified technical reviewer on all QC analytical assays, as needed.
• Support professional development of QC Analytics team members.
• Establish positive working relationships with internal and cross-functional teams.
• Support problem solving for technical issues pertaining to GMP QC, working alongside technical SMEs, as needed.
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment.
• Support Health Authority inspections.
• Must adhere to Iovance 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.

Required Education, Skills, and Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent) or an equivalent combination of education and experience.
• Minimum six (6) years of experience in the biopharmaceutical industry within a QC role, experience with cell therapy products is a plus.
• Solid understanding and functional knowledge with hands-on experience with at least one of the following : Cell Based Potency Assays and supporting ELISA platforms and / or Multi-color flow cytometry for identification, characterization, and potency analysis.
• Broad knowledge of biological drug development with respect to QC.
• Proficient in technical writing (e.g., test methods, SOP’s, protocols, etc.)
• Extremely detail-oriented with strong technical skills
• Strong written and verbal communication skills
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
• Demonstrate sense of urgency; ability to recognize time sensitivity.
• Flexible and adaptable style with an eagerness to take on challenges.
• Problem solver who not only identifies issues but leads efforts to resolve them.

Preferred Education, Skills, and Knowledge

• Advanced degree in a relevant discipline (biological sciences or equivalent)
• Experience supervising a team
• Experience with cell and / or gene therapy products

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 Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, 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 a 10-hr day 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 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 deadlines.

Work Environment :

• This position will work in both an office and a QC laboratory setting.
• When in the lab, must be able to work in laboratory setting with various chemical / biochemical exposures.
• 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 [email protected].