Senior Quality Control Specialist

2 weeks ago

Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time
Job Overview

Position Title: Lead Quality Control Analyst

Company: Iovance Biotherapeutics Inc

Salary: Competitive

Company Overview:

Iovance Biotherapeutics is an innovative company at the forefront of developing and commercializing advanced cancer immunotherapies. We are seeking a dedicated Quality Control Analyst to enhance our quality control testing operations at our integrated Cell Therapy Center (iCTC).

Key Responsibilities:

  • Serve as a technical subject matter expert (SME) for potency and flow testing, providing training to new laboratory staff.
  • Conduct daily GMP Quality Control laboratory testing at the iCTC facility, ensuring compliance with all relevant procedures, standards, and GMP regulations.
  • Perform data analysis and report final results to facilitate product lot release, adhering to established turnaround times.
  • Maintain compliance with GMP/GDP standards in all activities.
  • Assist in the creation and revision of documentation, including SOPs, protocols, reports, deviations, laboratory investigations, CAPAs, and change controls.
  • Support comprehensive GMP investigations for out-of-specification test results and other quality events.
  • Engage in technical problem-solving related to GMP Quality Control issues.
  • Contribute to product stability programs through execution of stability testing and data analysis.
  • Ensure high levels of efficiency and accuracy in all laboratory results.
  • Conduct peer and technical reviews of laboratory data and logbooks.
  • Analyze assay-specific analytical performance trends.
  • Assist during Health Authority inspections.
  • Provide insights during functional laboratory and cross-functional team meetings.
  • Fulfill additional responsibilities as assigned.

Qualifications:

  • Bachelor's degree in a relevant field (biological sciences or equivalent).
  • A minimum of three (3) years of experience in the pharmaceutical industry within a GMP Quality Control capacity; experience with cell therapy products is advantageous.
  • Proficiency in Flow Cytometry and Cell-based ELISA platforms.
  • Ability to collaborate effectively with multidisciplinary teams.
  • Detail-oriented with strong technical capabilities.
  • Skilled in managing multiple priorities under tight deadlines.
  • Demonstrated ownership and accountability in work responsibilities.
  • Ability to recognize and act on time-sensitive tasks.

Preferred Qualifications:

  • Experience with cell therapy products and/or relevant technical skills (NC 200, ELISA, and/or Flow).

Physical Requirements:

  • Must be able to wear appropriate cleanroom attire and Personal Protective Equipment (PPE).
  • Must meet requirements for and be able to wear a half-face respirator.
  • Able to stand and/or walk for the majority of the workday, which may include climbing ladders or steps.
  • Must possess near vision to view samples at close range.
  • Able to perform activities involving crouching, bending, twisting, reaching, and repetitive motions.
  • Must be able to lift and carry objects weighing up to 30 pounds.

Mental Requirements:

Ability to think clearly and conceptually; excellent judgment and problem-solving skills; capacity to manage work-related stress and multiple priorities simultaneously; ability to meet deadlines.

Work Environment:

This role will involve working in both an office and manufacturing environment. Exposure to various chemicals/biochemicals, including latex and bleach, may occur. Additionally, there may be variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers.

Iovance is committed to fostering a diverse and inclusive workplace. We are an equal-opportunity employer, and all employees and applicants will be considered without regard to 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, or any other characteristic protected by applicable law.

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