TScan Therapeutics
Sr. QC Analyst
TScan Therapeutics, Waltham, Massachusetts, United States, 02254
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 Quality Control (QC) professionals to join our team as Senior Quality Control Analysts, 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. The ideal candidate must be willing to work a rotating shift which includes weekend work.
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.
Well-versed in aseptic technique and gowning into Grade 7 and 8 suites.
Performs environmental monitoring and data analysis in Grade 7 and 8 suites.
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.
Trains 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.
Ability to work a rotating shift, which includes weekends.
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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 Quality Control (QC) professionals to join our team as Senior Quality Control Analysts, 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. The ideal candidate must be willing to work a rotating shift which includes weekend work.
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.
Well-versed in aseptic technique and gowning into Grade 7 and 8 suites.
Performs environmental monitoring and data analysis in Grade 7 and 8 suites.
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.
Trains 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.
Ability to work a rotating shift, which includes weekends.
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