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

Summary:

The Analytical Sciences & Technology Specialist I is responsible for the technical advancement of quality assurance methodologies and processes, including method and instrument validations, as well as technical transfers associated with Analytical and/or Microbiological quality control assessments of products, raw materials, and packaging components. This role involves the operation and maintenance of quality control instruments in accordance with cGMP/FDA regulations and Iovance's standard operating procedures.

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 documentation, including SOPs, aseptic techniques, gowning, testing, and EHS protocols.
  • Prepares necessary documents, forms, and records, such as method or instrument qualification/validation records, adhering to Good Documentation Practices.
  • Supports internal and external audits and inspections as required.
  • 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, along 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 a high level of ownership and accountability.
  • Exhibits a sense of urgency and recognizes time-sensitive tasks.
  • Proficient 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:

  • Ability to wear appropriate Personal Protective Equipment (PPE), including scrubs, gowns, masks, and gloves.
  • Capable of working in a laboratory environment with biohazards and various chemicals.
  • Must be able to stand and/or walk for 90% of the workday, with the ability to lift and carry objects weighing up to 45 pounds.
  • Requires visual acuity for data analysis and extensive reading.
  • Ability to communicate effectively with colleagues.

Work Environment:

This position involves both office and laboratory settings, with potential exposure to hazardous or biological waste.

Iovance is dedicated to fostering a diverse and inclusive workplace, ensuring equal opportunity for all employees and applicants.

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