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Analytical Sciences Specialist

1 month ago

Philadelphia, Pennsylvania, United States Iovance Biotherapeutics, Inc. Full time
About the Role

The Analytical Sciences Specialist will be accountable for the technical development of quality control methods and processes, method and instrument validations, and technical transfers related to Analytical and/or Microbiological quality control testing of products, raw materials, and packaging components at the site.

Responsibilities
  • Executes testing for method and instrument implementation and qualification/validation protocols.
  • Supports Phase II LIR OOS/OOT investigational testing.
  • Responsible for the timely completion of required tasks, including SOPs, aseptic techniques, gowning, testing, and EHS.
  • Prepares applicable documents, forms, and records, such as method or instrument qualification/validation records, and follows Good Documentation Practices.
  • Supports internal and external Audits and Inspections, if needed.
  • Adheres to Iovance Biotherapeutics' core values, policies, procedures, and business ethics.
Requirements
  • A minimum of a bachelor's degree in biology, Biochemistry, Microbiology, Chemistry, or related scientific field and 1-3 years of experience.
  • Solid understanding and functional knowledge with hands-on experience with Flow Cytometry, Cell-based ELISA, cell culture (primary cells and cell lines), and molecular assays.
  • Proficient in performing technical writing (e.g., test methods, SOPs, protocols, etc.).
  • Successfully interface with multi-disciplined teams.
  • Extremely detail-oriented with strong technical skills.
  • Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
  • High level of ownership and accountability.
  • Demonstrate a sense of urgency; ability to recognize time sensitivity.
  • Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
Preferred Requirements
  • Master's degree with four years of experience.
  • Experience with cell therapy products is a plus.
Work Environment

This position will work in both an office and a laboratory setting. When in the lab, there may be a risk of exposure to hazardous or biological waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning, and/or disposal of contaminated areas and waste.