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Job 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 an experienced professional to join our team as Director of QC supporting release characterization and environmental monitoring EM testing for cellular drug products manufactured internally at TScan Reporting to the Associate Vice President of QC and AD the ideal candidate should have relevant experience in compendial cellular molecular and environmental monitoring in a cGMP facility and enjoy fast paced collaborative and vibrant culture A team player with a sense of urgency will thrive in this role Responsibilities Maintain a culture of constant improvement and compliance with cGMP Manage QC team execution of internal STAT and release testing for disposition of Phase 12 clinical trial drug products per target release timingEnsure GMP lab is maintained in a constant state of compliance and inspection readiness Support QMS compliance through timely review of documents and ensuring QC support of QualityCMC documentationDrive sense of urgency through effective meeting cadence and scope as well as appropriate delegation of tasks and duties Support personnel development including efficient cross training and organizational design of QC release team Manage QC QMR metrics reporting to Senior Leadership Team Requirements Education Masters and 12 years of direct cGMP experience OR BS and 15 years OR PhD and 10 yearsExperience in cell therapy manufacturing for clinical stage products strongly preferredDeep knowledge of USP EP ICH and Cell Therapy regulatory guidanceManagement of cross trained multi disciplinary teams in an active cGMP release testing environment including responsibility for COA generation and approvalExperience developing and managing stability programs in the clinical environment Able to execute responsibilities at the Director levelExperience managing multi shift operations preferred About TScan TScan Therapeutics is a fully integrated next generation TCR T cell therapy company Founded in 2018 TScans platform was developed by Stephen Elledge PhD and Tomasz Kula PhD at Brigham and Womens Hospital and Harvard Medical School TScans transformative platform enables rapid discovery of TCRs and targets for engineered T cell therapy This technology is extremely versatile and is applicable across multiple therapeutic areas beyond cancers including autoimmune disorders and infectious diseases Do YOU have the anatomy of a TScanner Our talented compassionate and intelligent team is what makes TScan a Top Place to Work as ranked by The Boston Globe Our state of the art offices with over 70000 square feet of premium lab space including an internal GMP manufacturing suite are an environment that supports innovation camaraderie and professionalism We are passionate fun flexible and team oriented Sound like you Apply today EEO Statement TScan is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race color religion age sex national origin disability status genetics protected veteran status citizenship status sexual orientation gender identity or expression or any other characteristic identified by federal state or local laws where we operate TScan provides reasonable accommodations to qualified applicants and employees with disabilities To begin an interactive dialogue with TScan regarding a reasonable accommodation in connection with the hiring process andor to perform the responsibilities of the position for which the applicant has applied please contact the recruiter Pay Range 210000 220000 Pay Transparency TScan Therapeutics pay ranges are established based on external market data from third party compensation surveys and our internal benchmarking This role is eligible for an annual bonus and annual equity awards Some roles may also be eligible for overtime pay in accordance with federal and state requirements Individual compensation within this range is commensurate with a candidates specific qualifications including education overall experience relevant experience and specific skills We strive to ensure that compensation is competitive equitable and aligned with the value each TScanner brings to the role Recruitment & Staffing Agencies TScan Therapeutics does not accept unsolicited resumes from any source other than candidates The submission of unsolicited resumes by recruitment or staffing agencies to TScan Therapeutics or its employees is strictly prohibited unless contacted directly by TScan Therapeutics internal Talent Acquisition team Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of TScan Therapeutics and TScan Therapeutics will not owe any referral or other fees with respect thereto
Job Overview
Salary:
Not disclosed
JOB TYPE:
Not specified
Experience:
15+ years
Job Location:
Waltham, MA
Job Level:
Not specified
Education:
Graduation
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Job Title: Director, Quality Control
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Director, Quality Control at TScan Therapeutics
Job Title: Director, Quality Control
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