Senior QC Analyst

4 weeks ago

Waltham, United States TScan Therapeutics Full time
Job DescriptionJob Description

Position Summary:

TScan Therapeutics is a clinical stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Quality Control (QC) professional to join our team as a Senior Quality Control Analyst, supporting our internal GMP cell therapy manufacturing.

The Senior QC Analyst position interacts regularly with TScan's Quality Assurance, Analytical Development, Process Development, Manufacturing, Facilities, as well as TScan's external test laboratories, where applicable. This position supports the execution, transfer, qualification and validation of all QC analytical methods and activities necessary to support the release of cellular drug products at our Waltham cell therapy manufacturing facility.

Responsibilities

  • Performs Bio-Analytical testing such as Flow Cytometry, ELISA, qPCR, cell count, (incoming, in-process and final product release testing).
  • Collaborates with Analytical Development team in the transfer of assays to QC.
  • Performs Microbiological/sterility testing and activities in compliance with applicable SOPs and procedures
  • Ensures maintenance and control of QC test samples
  • Maintains controls, reagents, and reference standards to support testing
  • Maintains retain and stability samples
  • Reviews/approves data generated by other team members
  • Train others
  • Executes validation/optimization of test methods as per appropriate protocols
  • Contributes to OOS/OOT and deviation investigations
  • Participates in deviation investigation/CAPA implementation in a timely manner
  • Supports and assists TSCAN Quality Assurance and Quality Control projects
  • Continually identifies areas for improvements in project work
  • Supports tracking and trending systems, and programs which assist in the testing, evaluation and monitoring of quality and efficiency
  • Reviews QC documentation, to ensure completeness, accuracy, consistency, and clarity
  • Generates/revises protocols/reports, SOPs, forms, laboratory data sheets
  • Reviews, maintains QC laboratory documentation (logbooks, forms etc.)
  • Maintains the QC/Microbiology labs and associated equipment daily
  • Supports the Product Analytical Development team, where applicable

Requirements:

  • Requires a bachelor’s degree in Biochemistry, Microbiology, Molecular and Cellular Biology or Biology
  • Quality Control and/or Analytical Development experience in Biotech, cGMP areas
  • 5+ years of relevant biotech/pharma industry experience
  • Strong cGMP skills
  • Strong communications skills, team player
  • Experience with sample management compliance
  • Experience working in a laboratory environment
  • Able to lead, mentor and inspire others
  • Experience in gene therapy cGMP manufacturing and testing
  • Role model for TSCAN company values.

About TScan:

TScan Therapeutics was founded in 2018 by a small group of scientists led by Dr. Stephen Elledge (Harvard Medical School/HHMI). TScan is discovering and developing novel TCR-engineered T cell therapies for the treatment of cancer. TScan’s discovery platform is centered around a breakthrough technology that enables the rapid, comprehensive, and genome-wide identification of the peptide antigen targets of T cell receptors. This technology greatly enhances our ability to understand the specific antigens that drive important disease processes, including tumor cell recognition by the immune system, self-reactivity in autoimmune disorders, and acquired immunity in infectious disease. TScan is using the platform in oncology to discover new TCR/target pairs and to rapidly move novel TCRs into clinical development.

Do YOU have the anatomy of a TScanner?

Our talented, compassionate, and intelligent team is what makes TScan a great place to work. Our brand-new offices with over 40,000 square feet of premium lab and office space is an environment that supports innovation, camaraderie and professionalism. We are driven, passionate, fun, flexible and team oriented. Sound like you? Apply today.

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