Director, Quality Control Lab Technical Support

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies.

The Director, Quality Control Lab Technical Support will lead the quality control technical support team in the planning, execution, and documentation of QC co-qualifications, validations, and assay transfers occurring at Iovance’s integrated Cell Therapy Center (iCTC).

The Quality Control technical programs include, but are not limited to, assay co-qualification, assay validation, assay technical transfer, capacity studies, clinical testing support, reagent qualification, comparability studies, and training with a focus on cell therapy products.

The incumbent will direct quality control assay qualification, validation and transfer activities to support growth of Iovance’s Cell Therapy Center (iCTC) assays for both analytical and microbiological testing.

The quality control analytical programs include in-process and final drug product analytical assays such as potency and flow cytometry.

The quality control microbiology programs include in-process and final drug product microbial assays such as endotoxin, mycoplasma, gram stain, environmental monitoring, and sterility techniques.

Other responsibilities will include supporting capacity studies, training, reagent qualification, comparability studies, and clinical testing.

To be successful in this role, you will have strong leadership and substantial experience lading quality control teams in a Pharmaceutical or Biotechnology environment.

This position works across different shifts. Depending on your assigned shift, you may be required to work weekends and holidays to complete assigned work.

Essential Functions and Responsibilities

• Direct the QC assay technical team through performance, technical writing, and review of assay transfers, validations, and qualifications with a focus in both analytical and microbiology testing activities.
• Collaborate effectively with Iovance Development and ASAT teams to perform assay co-qualification, validation, and technical transfer of updated and new assays, as well as potential new products.
• Collaborate effectively with Iovance Development and ASAT teams to perform assay co-comparability and PPQ work.
• Provide training support for the QC analytical and microbiological teams.
• Ensure all technical testing is performed according to company procedures and cGMP.
• Author, review, and approve technical assay documents including but not limited to protocols, reports, and procedures.
• Support reagent qualification for analytical and microbiological methods.
• Support testing needs for capacity studies.
• Support clinical and commercial testing as needed.
• Initiate and support quality documents such as deviations, laboratory investigations, CAPAs, and change controls.
• Support problem-solving during testing and for unexpected test results, working collaboratively with analysts and management as needed.
• Ensure that QC staff are adequately trained, perform tests per method procedures, and consistently implement the required techniques.
• Initiate, revise, and approve site-related analytical and microbiological procedures. Ensure all procedures reflect current operations.

Serve as a document reviewer, owner, or approver as appropriate.

• Participate in preparing CMC regulatory submissions and associated Health Authority interactions (e.g., IND, BLA submissions).
• Support the QC function interface during facility tours and pre-approval inspections.
• Accurately interpret and discuss all laboratory-related data within cross functional teams and with health authorities.

Required Education, Skills, and Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• Minimum 12 years of experience in the pharmaceutical industry within a Quality Control role
• Quality Control laboratory management experience, including management of direct reports.
• Broad knowledge of quality control for biologics with experience in a leadership role
• Successfully interface with multi-disciplined teams
• Extremely detail-oriented with strong analytical, written, and verbal communication skills
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
• High level of ownership and accountability
• Demonstrate a sense of urgency; ability to recognize time sensitivity.
• Flexible and adaptable style with an eagerness to take on challenges.
• Problem solver who identifies issues and leads efforts to resolve them

Preferred Education, Skills, and Knowledge

• Advanced degree (MSc. preferred.)
• Experience with both analytical and microbiological assays is preferred
• Experience with cell therapy products is a plus.

Physical Demands and Activities Required :

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.

• Must be able to wear appropriate clean room attire and all 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 work day 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 45 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 lab setting. When in the lab, you may be exposed to various chemical / biochemical exposures, including latex and bleach.

Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents / sanitizers.

Able to work in 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 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 careers@iovance.