Quality Control Analyst I, IOVA-A [Contract to Hire]

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

Iovance is seeking a highly motivated Quality Control I / II Analyst at Iovance’s IOVA-A facility located within American Red Cross (ARC) in Philadelphia, PA.

This Iovance facility produces a critical raw material used in the company’s TIL process.

The quality control testing programs at IOVA-A include the responsibility to performs iPBMC (irradiated peripheral blood mononuclear cells) lot release, stability testing, method qualification and validation and writing / review of QC procedures.

Typical test methods performed include Cell Counts (automated NC200) and Cell Proliferation, etc.

Location :

700 Spring Garden Street

Philadelphia, Pennsylvania

19123

Days & Hours : Monday to Friday : 3pm to 11 : 30pm

Essential Functions and Responsibilities

• Perform daily GMP quality control laboratory testing activities at IOVA-A facility with minimal to no errors.
• Perform data analysis and final result reporting to support product lot release with adherence to turnaround times.
• Perform all activities with respect to GMP compliance.
• Support thorough GMP investigations for out of specification test results and other quality events.
• Support technical problem solving for issues pertaining to GMP quality control. Support problem solving for technical issues pertaining to GMP quality control, working alongside technical SMEs as needed
• Support product stability programs including execution of stability testing, stability data analysis, and final reporting of stability data.
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.
• This position is currently for regular work week hours; however, due to the nature of testing schedules, must be willing to work alternative shifts, weekends, evenings, and holidays, as needed.

May be required to work overtime.

• It is also expected that regular work weeks may change and may involve shift changes.
• Perform miscellaneous duties as assigned.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Must adhere to Iovance Biotherapeutics' core values, policies, procedures and business ethics.

Required Education, Skills, and Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• knowledge of biological drug development with respect to Quality Control
• Minimum (1-3) years of experience in the biopharmaceutical industry within a Quality Control role; experience with cell and / or gene therapy products is a plus
• Successfully interface with multi-disciplined teams in a global setting
• 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

Preferred Education, Skills, and Knowledge

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.

Physical Demands and Activities Required :

Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors. 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.
• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Ability to lift 20 lbs.

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 :

• Able to work in cleanroom with biohazards, human blood components, chemicals, and variable noise levels.
• Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards and strong odors.
• This position will work in both an office and a manufacturing lab setting.
• When in the lab, must be able to work in Lab setting with various chemical / biochemical exposures, including latex and bleach.

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 regards 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].