Quality Control Analytics Supervisor

2 weeks ago

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

Position: Supervisor, Quality Control Analytics

Salary: Competitive

Summary: The Supervisor of Quality Control Analytics is responsible for overseeing the QC Analytics programs and testing operations at Iovance Biotherapeutics. This role encompasses various testing activities, including in-process, final product, and stability assessments for both clinical and commercial batches. Candidates should possess hands-on expertise in at least two of the following areas: cell maintenance and quantification (NC-200), cell-based potency evaluations using diverse immunoassays (such as ELISA), and/or identification and characterization assays utilizing multi-color flow cytometry platforms. This position plays a crucial role in the establishment of QC Analytical release assays and related functions within a newly developed facility for cell therapy products.

Key Responsibilities:

  • Conduct all tasks independently with minimal oversight.
  • Oversee the execution of laboratory activities, including release testing and maintenance tasks.
  • Manage the technical transfer, qualification, and validation of QC Analytical test methods for in-process materials, lot release, and stability.
  • Perform daily GMP QC laboratory testing activities at the facility.
  • Draft, review, and approve SOPs, protocols, reports, specifications, and other QC documentation.
  • Ensure timely data entry for all generated results.
  • Lead investigations into out-of-specification test outcomes, implementing corrective actions and verifying their effectiveness.
  • Support product stability initiatives, including the creation of stability protocols, execution of stability tests, and transfer of results to external QC.
  • Guarantee that daily GMP QC laboratory testing is conducted with minimal errors and in compliance with all relevant procedures, standards, and GMP regulations.
  • Enhance technical skills through qualification on all QC analytical release assays.
  • Act as a qualified trainer for all QC analytical release assays, as necessary.
  • Serve as a qualified technical reviewer for all QC analytical assays, as needed.
  • Foster professional development among QC Analytics team members.
  • Build positive working relationships with internal and cross-functional teams.
  • Assist in resolving technical issues related to GMP QC, collaborating with technical subject matter experts as required.
  • Maintain a high level of efficiency, producing accurate results in a fast-paced environment.
  • Support Health Authority inspections.
  • Adhere to Iovance Biotherapeutics' core values, policies, procedures, and ethical standards.
  • Comply with Safety SOPs, SDS sheets, and laboratory protocols in accordance with company policy and OSHA regulations.
  • Perform additional duties as assigned.

Qualifications:

  • Bachelor's degree in a relevant field (biological sciences or equivalent) or a comparable combination of education and experience.
  • A minimum of six (6) years of experience in the biopharmaceutical sector within a QC capacity, with experience in cell therapy products being advantageous.
  • Strong understanding and practical knowledge with hands-on experience in at least one of the following: Cell Based Potency Assays and supporting ELISA platforms and/or Multi-color flow cytometry for identification, characterization, and potency analysis.
  • Comprehensive knowledge of biological drug development concerning QC.
  • Proficient in technical writing (e.g., test methods, SOPs, protocols, etc.).
  • Highly detail-oriented with robust technical skills.
  • Excellent written and verbal communication abilities.
  • Capacity to effectively manage multiple priorities under tight deadlines.
  • Demonstrated sense of urgency and ability to recognize time-sensitive tasks.
  • Flexible and adaptable with a willingness to tackle challenges.
  • Proactive problem solver who identifies issues and leads resolution efforts.

Preferred Qualifications:

  • Advanced degree in a relevant field (biological sciences or equivalent).
  • Experience in supervising a team.
  • Experience with cell and/or gene therapy products.

Physical and Mental Demands:

  • Must be able to wear appropriate Personal Protective Equipment (PPE), including scrubs, gowns, masks, gloves, etc.
  • Must meet requirements for and be able to wear a half-face respirator.
  • Able to stand and/or walk for 90% of a 10-hour day, which may include climbing ladders or steps.
  • Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
  • Must be able to lift and carry objects weighing up to 30 pounds.

Work Environment:

  • This position involves working in both an office and a QC laboratory setting.
  • When in the lab, exposure to various chemical/biochemical substances is possible.
  • Potential exposure to noise, equipment hazards, and strong odors.

The information provided in this document is intended to outline the general nature and level of work performed by an employee in this role. It is not intended to be an exhaustive list of functions, duties, or local variations. Management retains the discretion to modify the responsibilities of the position at any time.

Iovance is dedicated to fostering a diverse and inclusive workplace. As an equal-opportunity employer, we consider all employees and applicants 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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