Senior Director, Quality Control, Bioanalytical

Overview

The Senior Director of Quality Control is the recognized Bioanalytical expert and leads all Bioanalytical quality control operations at Iovance's integrated Cell Therapy Center (iCTC). The incumbent will direct all Bioanalytical quality control programs for the clinical and commercial cell therapy programs at the iCTC. The quality control programs include all Bioanalytical in-process and final drug product testing, for example, Cell-Based Potency Bioassays, Flow Cytometry, Cell Counting techniques, PCR (Quantitative, Droplet Digital or Digital, etc.), and others. The Senior Director will apply practical knowledge of cGMPs and regulatory requirements in the product life cycle as related to quality control.

Essential Functions and Responsibilities

• All duties are performed independently with minimal supervision and oversight.
• Direct the day-to-day GMP QC testing activities at the iCTC facility including quality control testing for cell therapy intermediates and final products.
• Build and lead the QC function at iCTC with hands-on work to instruct and build the expertise through each phase of facility expansion and product validations.
• Manages product lot release with adherence to turnaround times.
• Manage the Bioanalytical program for the facility.
• Coordinates quality control-related activities with respect to timelines and compliance.
• Lead and facilitate thorough GMP investigations for Laboratory investigations, out of specification test results, corrective actions, and verification of effectiveness.
• Support problem solving for issues pertaining to GMP quality control, working collaboratively with technical SMEs as needed.
• Support product stability programs including testing according to the agreed stability strategy, and approved Provide data in support of stability data analysis, and final reporting of stability data.
• Receive the technical transfer of revised or new methods, ensuring that adequate documentation (i.e., written test method), controls, and training are in -place.
• Ensure that QC staff are adequately trained and are performing tests in accordance with method procedures and are consistent with implementing the required techniques.
• Initiate, revise, and approve site-related quality control procedures. Ensure all procedures reflect current Serve as a document reviewer, owner, and approver as appropriate.

• Establish, maintain, and/or participate in processes for all the above.
• Participate in the preparation of CMC regulatory submissions and associated Health Authority interactions (e.g., IND, BLA submissions).
• Lead 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.
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.
• 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)
• Minimum ten (10) 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 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 preferred
• Experience with cell therapy products 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 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 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 10-hr 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
• When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
• 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 [redacted].

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