Tscanrx
Senior Director, Quality Assurance (QA13-7)
Tscanrx, Waltham, Massachusetts, United States, 02254
Senior Director, Quality Assurance (QA13-7)
LOCATION:Waltham, MA
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 Dir/Sr. Director of Quality to lead Quality Assurance for in-house and virtual GMP operations supporting the company’s novel TCR-engineered T cell therapy products. This role will reside within Technical Operations and Quality and will report to the Senior Vice President of TO&Q. Key activities will include supporting efforts for near term IND submissions and clinical manufacturing, identifying and hiring key talent to expand the department, building a compliant and flexible QMS, and defining growth plans to meet the company’s mid- and long-term strategic initiatives.The ideal candidate: (i) will have a strong background in Quality and firm understanding of the cGMPs and ICH guidelines related to the manufacture and testing of human cell and gene therapy products, orphan drugs, or other complex and novel dosage forms; (ii) will be an exceptional manager and leader, (iii) will be a steadfast problem solver who thrives in a fast-paced, lean and agile environment; and (iv) is a team player who can foster productive relationships with internal colleagues and with external partners.RESPONSIBILITIES:Build and manage TScan’s Quality Assurance teamOversee development of personnel within the quality department, building a strong team and clear vision to drive best in class performanceContinue to build and manage TScan’s Quality Management SystemProvide strategic leadership to the Quality operations group for sustained quality system programs with a continuous focus on improvementCollaborate with the Heads of Pre-Clinical and Clinical development to manage all GxP operationsOversee Quality Operations including lot disposition, incoming receipt, QA on the floor, and run the Material Review BoardDirect Quality Systems including document management, change control, exception management, CAPA, and trainingCoordinates and executes periodic Quality Management Reviews and trend analysis of all aspects of cGMP operationsManage audits and inspections by clients, FDA, and other regulatory agenciesWork with supply chain, external suppliers, and contract labs to ensure compliance and quality, including management of audits and quality agreementsIdentify and initiate improvements to the quality management system, ensuring compliance to all relevant quality standards and regulatory requirementsEnsure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions to the adhered timelines as appropriateEnsures the company is in a constant state of inspection readiness across all functions through continuous education, training, and internal auditsPrepare the QA function to support registrational trials and ultimately commercial activitiesEnsure timely release of clinical and commercial product batchesREQUIREMENTS:15+ years of relevant experience; degree emphasis in biological sciences, biochemistry, cell biology, or related field is preferredStrong background in Quality Assurance and Compliance, both FDA and EU regulationsExperience dispositioning Drug Product for use in Clinical and CommercialProven ability to build and develop strong teams, as well as robust and flexible systemsCreativity, critical thinking, ability to innovate, and problem solvingExcellent communication skills (both written and oral)Significant experience drafting manufacturing documentation and supporting documentation for regulatory filingsExperience in cell and gene therapies strongly desiredAbout TScan:TScan Therapeutics was founded in 2018 by a small group of scientists led byDr. 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 approximately 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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LOCATION:Waltham, MA
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 Dir/Sr. Director of Quality to lead Quality Assurance for in-house and virtual GMP operations supporting the company’s novel TCR-engineered T cell therapy products. This role will reside within Technical Operations and Quality and will report to the Senior Vice President of TO&Q. Key activities will include supporting efforts for near term IND submissions and clinical manufacturing, identifying and hiring key talent to expand the department, building a compliant and flexible QMS, and defining growth plans to meet the company’s mid- and long-term strategic initiatives.The ideal candidate: (i) will have a strong background in Quality and firm understanding of the cGMPs and ICH guidelines related to the manufacture and testing of human cell and gene therapy products, orphan drugs, or other complex and novel dosage forms; (ii) will be an exceptional manager and leader, (iii) will be a steadfast problem solver who thrives in a fast-paced, lean and agile environment; and (iv) is a team player who can foster productive relationships with internal colleagues and with external partners.RESPONSIBILITIES:Build and manage TScan’s Quality Assurance teamOversee development of personnel within the quality department, building a strong team and clear vision to drive best in class performanceContinue to build and manage TScan’s Quality Management SystemProvide strategic leadership to the Quality operations group for sustained quality system programs with a continuous focus on improvementCollaborate with the Heads of Pre-Clinical and Clinical development to manage all GxP operationsOversee Quality Operations including lot disposition, incoming receipt, QA on the floor, and run the Material Review BoardDirect Quality Systems including document management, change control, exception management, CAPA, and trainingCoordinates and executes periodic Quality Management Reviews and trend analysis of all aspects of cGMP operationsManage audits and inspections by clients, FDA, and other regulatory agenciesWork with supply chain, external suppliers, and contract labs to ensure compliance and quality, including management of audits and quality agreementsIdentify and initiate improvements to the quality management system, ensuring compliance to all relevant quality standards and regulatory requirementsEnsure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions to the adhered timelines as appropriateEnsures the company is in a constant state of inspection readiness across all functions through continuous education, training, and internal auditsPrepare the QA function to support registrational trials and ultimately commercial activitiesEnsure timely release of clinical and commercial product batchesREQUIREMENTS:15+ years of relevant experience; degree emphasis in biological sciences, biochemistry, cell biology, or related field is preferredStrong background in Quality Assurance and Compliance, both FDA and EU regulationsExperience dispositioning Drug Product for use in Clinical and CommercialProven ability to build and develop strong teams, as well as robust and flexible systemsCreativity, critical thinking, ability to innovate, and problem solvingExcellent communication skills (both written and oral)Significant experience drafting manufacturing documentation and supporting documentation for regulatory filingsExperience in cell and gene therapies strongly desiredAbout TScan:TScan Therapeutics was founded in 2018 by a small group of scientists led byDr. 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 approximately 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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