Senior Quality Control Analyst, Lab Technical Support, Analytical

3 weeks ago


Philadelphia, Pennsylvania, United States Iovance Biotherapeutics, Inc. Full time
Job Summary

We are seeking a highly skilled Senior Quality Control Analyst to join our team at Iovance Biotherapeutics, Inc. in a Lab Technical Support, Analytical role. The successful candidate will support quality control technical support testing and related activities at our integrated Cell Therapy Center (iCTC).

Key Responsibilities
  • Collaborate with Iovance Development and ASAT teams to perform assay co-qualification, validation, and technical transfer of updated and new assays.
  • Act as a subject matter expert and train laboratory personnel on assays.
  • Perform all activities with respect to GMP/GDP compliance.
  • Support thorough GMP investigations for quality events.
  • Author, review, and approve technical assay documents.
  • Support technical problem solving for issues pertaining to GMP Quality Control.
  • Assist in the generation and revisions of documentation, such as SOPs, protocols, and reports.
  • Initiate and support quality documents, such as deviations, laboratory investigations, CAPAs, and change controls.
  • Perform technical review of laboratory data and logbooks.
  • Operate at a consistent and high level of efficiency, producing high-quality and accurate results.
  • Support Health Authority inspections.
  • Provide input to functional laboratory team meetings.
Requirements
  • Bachelor's degree in Biology, Biochemistry, Microbiology, Chemistry, or related scientific field or equivalent combination of education and experience.
  • Minimum three (3) years of GMP experience in the pharmaceutical industry within a Quality Control or related role.
  • Solid understanding and functional knowledge with hands-on experience with two (2) or more of the following: Multicolor Flow Cytometry, Cell-based ELISA, cell culture with cell enumeration (NC-200).
  • Experience in technical writing.
  • Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
  • Successfully interface with multi-disciplined teams.
  • Extremely detail-oriented with strong technical skills.
  • High level of ownership and accountability.
  • Demonstrate sense of urgency; ability to recognize time sensitivity.
  • Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
Preferred Qualifications
  • Experience with cell therapy products.
  • Relevant technical skills (NC 200, ELISA, and/or Flow).
Work Environment

This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers.

Iovance Biotherapeutics, Inc. is an equal-opportunity employer and welcomes applications from diverse candidates. If you need assistance or accommodation to apply to one of our opportunities, please contact us.



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