Overview

The Quality Control Specialist responsible for the executed test methods review and raw data review for lot release. The role has a good understanding of Quality Control and apply practical knowledge of phase appropriate GMPs 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.

Shift:

• Sunday - Wednesday from 9am-7pm

OR

• Wednesday- Saturday from 9am to 7pm
  

Essential Functions and Responsibilities

• Observe and provide feedback of technical operations, ensure alignment of technical laboratory practices across multiple facilities.
• Supports Technology Transfer related to new validated assays or process improvements to internal and external laboratory facilities. Provide hands-on technical training to laboratory personnel as part of process tech transfer as needed.
• Translate validation reports into technical test methods and SOPs as part of tech transfers. Will assist QC and QA when authoring Test Methods and implementing process improvements.
• The Specialists may be responsible to support the authoring documentation such as Impact and Risk Assessments and Failure Modes Risk Analysis.
• Review GMP QC testing for lot release across CMO and CTL network ensuring alignment with approved methods and regulatory requirements and ensure practices are compliant with global current good manufacturing practices (cGMP) and ICH guidelines.
• Manage CoA reviews to support testing of various stages of pipeline, ensure deadlines are met.
• Analyze and interpret technical laboratory data. Emphasize operational excellence and continuously identify process improvements, i.e. efficiencies, within the laboratory operations
• Support GMP investigations for out of specification test results and corrective actions
• Support problem solving for technical issues pertaining to GMP quality control, 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
• Due to the nature of testing schedules, must be willing to work weekends, evenings, and holidays, as needed.
• All duties are performed with minimal supervision and oversight
• Performs other duties as assigned.

Required Education, Skills, and Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• Broad knowledge of biological drug development with respect to Quality Control. Technical knowledge in cell-based assays (cell culture, flow cytometry, ELISA) is a plus
• Minimum 2 years of experience in the biopharmaceutical industry within a Quality Control role
• 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.
• 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

• Experience with cell and/or gene 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 remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.
• Availability to travel to support technology transfer

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 job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.

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.com.

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