Quality Control Analytics Supervisor

2 weeks ago

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

Salary: Competitive

Summary:

The Quality Control Analytics Supervisor is responsible for overseeing the QC Analytics programs and testing operations at Iovance Biotherapeutics Inc. This role encompasses in-process, final product, and stability testing for both clinical and commercial batches. Candidates should possess hands-on experience in at least two of the following areas: cell maintenance and cell count determination, cell-based potency assays utilizing various immunoassays, or identification and characterization assays using multi-color flow cytometry platforms. This position plays a crucial role in the establishment of QC Analytical release assays and other initiatives within a newly constructed facility dedicated to cell therapy products.

Key Responsibilities:

  • Independently manage all laboratory activities with minimal supervision.
  • Oversee the execution of laboratory testing and maintenance tasks.
  • Supervise the technical transfer, qualification, and validation of QC Analytical test methods.
  • Conduct daily GMP QC laboratory testing at the facility.
  • Draft, review, and approve SOPs, protocols, reports, and other QC documentation.
  • Ensure timely data trending for all generated results.
  • Lead investigations into out-of-specification results and implement corrective actions.
  • Support product stability programs by developing stability protocols and executing testing.
  • Guarantee compliance with all applicable procedures, standards, and GMP regulations during testing.
  • Enhance technical capabilities through qualification on all QC analytical release assays.
  • Act as a qualified trainer and technical reviewer for QC analytical assays.
  • Foster professional development among QC Analytics team members.
  • Build positive relationships with internal and cross-functional teams.
  • Assist in resolving technical issues related to GMP QC.
  • Maintain a high level of efficiency and accuracy in a fast-paced environment.
  • Support Health Authority inspections.
  • Adhere to company values, policies, and safety regulations.
  • Perform additional duties as assigned.

Qualifications:

  • Bachelor's degree in a relevant field (biological sciences or equivalent) or a combination of education and experience.
  • At least six years of experience in the biopharmaceutical industry in a QC capacity, with experience in cell therapy products preferred.
  • Strong understanding and practical experience with cell-based potency assays and ELISA platforms or multi-color flow cytometry.
  • Comprehensive knowledge of biological drug development in relation to QC.
  • Proficient in technical writing, including test methods and SOPs.
  • Detail-oriented with robust technical skills.
  • Excellent written and verbal communication abilities.
  • Ability to manage multiple priorities effectively under tight deadlines.
  • Demonstrated urgency and adaptability in a dynamic environment.
  • Proactive problem solver with a focus on resolution.

Preferred Qualifications:

  • Advanced degree in a relevant field.
  • Experience in supervising a team.
  • Familiarity with cell and/or gene therapy products.

Physical and Mental Requirements:

  • Ability to wear appropriate Personal Protective Equipment (PPE).
  • Must meet requirements for wearing a half-face respirator.
  • Ability to stand and/or walk for the majority of a 10-hour workday.
  • Capability to lift and carry objects weighing up to 30 pounds.
  • Strong analytical and problem-solving skills.

Work Environment:

  • This position involves working in both an office and a QC laboratory setting.
  • Exposure to various chemical and biochemical substances may occur in the lab.
  • Potential exposure to noise and equipment hazards.

Iovance Biotherapeutics Inc is dedicated to fostering a diverse and inclusive workplace. We are an equal opportunity employer and welcome applicants from all backgrounds.

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