Manager, Quality Control Systems

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 Quality Control (QC) professional to join our team as Manager QC Systems, supporting our internal GMP cell therapy manufacturing.

The 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.

Responsibilities:

Manages, coaches, and develops the growing team of QC Analysts

Performs multiple bioanalytical testing assays such as flow cytometry, ELISA, qPCR, cell count, and rapid USP safety assays (sterility, endotoxin, mycoplasma).

Establish data systems and tools including LIMS, tracking, trending, and report out dashboards.

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.

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

Requirements:

BS/MS degree in a relevant scientific discipline required, at a minimum

10-12+ 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 data tracking, trending, and analysis skills.

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

About TScan:

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. 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.

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