Quality Control Analytical Specialist

2 weeks ago

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

Position Title: Analytical Sciences & Technology Specialist I

Salary: Competitive

Role Summary:
The Analytical Sciences & Technology Specialist I is responsible for the technical advancement of quality assurance methodologies and processes, including the validation of methods and instruments, as well as the technical transfer related to Analytical and/or Microbiological quality assurance testing of products, raw materials, and packaging components. This position also involves the operation and maintenance of quality control instruments in accordance with cGMP/FDA regulations and Iovance's standard operating procedures and policies. The role requires a solid understanding of quality control techniques, analytical instrumentation, sterility principles, and knowledge of radiation safety standards.

Work Schedule: Sunday - Thursday, 8:30 AM - 5:00 PM

Key Responsibilities:

  • Conducts testing for method and instrument implementation and qualification/validation protocols.
  • Assists with Phase II LIR OOS/OOT investigational testing.
  • Ensures timely completion of required tasks, including SOPs, aseptic techniques, gowning, testing, and EHS compliance.
  • Prepares necessary documentation, forms, and records, such as method or instrument qualification/validation records, adhering to Good Documentation Practices.
  • Supports internal and external audits and inspections as necessary.
  • Follows Iovance Biotherapeutics' core values, policies, procedures, and ethical standards.
  • Performs additional duties as assigned.

Qualifications:

  • Bachelor's degree in Biology, Biochemistry, Microbiology, Chemistry, or a related scientific discipline with 1-3 years of GMP experience.
  • Strong understanding and hands-on experience with Flow Cytometry, Cell-based ELISA, cell culture (primary cells and cell lines), and molecular assays.
  • Proficient in technical writing, including test methods, SOPs, and protocols.
  • Able to collaborate effectively with multi-disciplinary teams.
  • Detail-oriented with robust technical skills.
  • Capable of managing multiple priorities under tight deadlines.
  • Demonstrates high ownership and accountability.
  • Exhibits a sense of urgency and recognizes time sensitivity.
  • Skilled in Microsoft Office applications (Outlook, Excel, Word, PowerPoint).

Preferred Qualifications:

  • Master's degree with four years of relevant experience.
  • Experience with cell therapy products is advantageous.

Physical Requirements:
The physical demands of this role include the ability to wear appropriate Personal Protective Equipment (PPE), work in a laboratory environment with biohazards and various chemicals, and perform physical activities such as standing, walking, lifting, and carrying objects weighing up to 45 pounds. The position requires visual acuity for data analysis and the ability to communicate effectively with others.

Mental Requirements:
This role necessitates clear and conceptual thinking abilities, excellent judgment, problem-solving skills, and the capacity to manage work-related stress while handling multiple priorities and meeting deadlines.

Work Environment:
This position operates in both an office and laboratory setting, with potential exposure to hazardous or biological waste during various tasks.

Iovance is dedicated to fostering a diverse and inclusive workplace. As an equal-opportunity employer, we consider all applicants without regard to race, color, religion, sex, national origin, age, disability, marital status, sexual orientation, gender identity, or any other characteristic protected by law.

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