Position Summary: 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 1/2 clinical trial drug products per target release timing
- Ensure 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 Quality/CMC documentation
- Drive 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+ years
- Experience in cell therapy manufacturing for clinical stage products strongly preferred
- Deep knowledge of USP, EP, ICH, and Cell Therapy regulatory guidance
- Management of cross-trained multi-disciplinary teams in an active cGMP release testing environment including responsibility for COA generation and approval
- Experience developing and managing stability programs in the clinical environment
- Able to execute responsibilities at the Director level
- Experience managing multi-shift operations preferred
Pay Range: $210,000 - $220,000
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 candidate's 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.
