LOCATION: Waltham, MA
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 Quality Control (QC) professional to join our team as Manager/Senior Manager, supporting our internal GMP cell therapy manufacturing.
The Manager/Sr. Manager is a hands-on manager that can organize and lead a team of QC personnel, support and execute QC testing, and contribute significantly to overall Quality Control strategy The ideal candidate will have experience working in a GMP QC laboratory setting, experience with cell and gene therapy test methodologies, compendial safety testing and enjoy a fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.
- Manages, coaches, and develops the growing team of QC Analysts
- Plans and performs multiple bioanalytical testing assays such as flow cytometry, ELISA, qPCR, cell count, and rapid USP safety assays (sterility, endotoxin, mycoplasma).
- Manages QC quality records including, but not limited to, Deviations, Investigations, CAPAs, Change Controls, and ensures that all related activities are completed in a timely manner
- Establishes routine operations to govern QC activities, including scheduling sample testing, ordering supplies, oversight of QC equipment maintenance and calibration, performing documentation reviews, etc.
- Serves as the QC Subject Matter Expert (SME)
- Authors, reviews and approves QC-related documentation (CoA, Methods, SOPs, reports, etc.) and provides documentation support to QA, as needed
- Leads Out-Of-Specification investigations
- Collaborates with Product Analytical Development team in the transfer of analytical assays to QC
- Coordinates with Manufacturing for in-process and product release test sample submission and testing
- Attends functional meetings to discuss ongoing work
- BS/MS degree in a relevant scientific discipline required, at a minimum
- 8-10+ years of relevant biotech/pharma industry experience, including Quality Control experience supporting cGMP areas
- 3+ years’ experience supervising/managing direct reports
- Demonstrated industry knowledge of cGMP
- Experience leading people and/or projects with history of achieving results and outstanding outcomes
- Strong communications skills; a team player who can lead, mentor, and inspire others
- Experience participating and/or supporting regulatory inspections preferred
- Gene or cell therapy product experience preferred
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. TScan is using the platform in oncology to discover new TCR/target pairs and to rapidly move novel TCRs into clinical development with our internal GMP manufacturing and QC capabilities.
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.