Associate Scientist, MSAT

TScan Therapeutics•Waltham, MA

3d•Onsite

About The Position

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 Associate Scientist to join our Manufacturing Science and Technology (MSAT) team, supporting TScan�s cell therapy manufacturing process development and GMP production of clinical cell therapy candidates. The ideal candidate should have relevant experience in cell therapy process development, technology transfer to GMP manufacturing and GMP principles related to cell therapy, and enjoy fast-paced, collaborative and vibrant startup culture. A team player with a sense of urgency will thrive in this role.

Requirements

Bachelor�s or Master�s degree in Biological Sciences, Biomedical Engineering, Biotechnology, Chemical Engineering, or a related field with 5�8 years of experience in biopharmaceutical manufacturing, process development, or MSAT support.
Industry experience in cell therapy GMP manufacturing, process technical transfer, change management, and GMP quality systems is required.
Knowledge and experience with practices and equipment to run cell therapy manufacturing processes in a GMP environment, including Rotea, G-Rex, Prodigy, LOVO, etc.
This position may require 10-30% travel to CDMO in the US.
Working knowledge and experience with genetic material delivery by electroporation is preferred.
Working knowledge of GMP regulations and ICH/quality guidelines related to cell therapy manufacturing.
Excellent communication and interpersonal skills to coordinate complex technical/scientific CMC projects cross-functionally.
Excellent ability to handle multiple tasks while meeting timelines and adapting to changing priorities.
Highly organized with close attention to detail.

Nice To Haves

Working knowledge and experience with genetic material delivery by electroporation is preferred.

Responsibilities

Designs and executes laboratory-based studies to support new process/ equipment/materials implementation into GMP manufacturing to improve manufacturability and reduce COGs.
Contributes to technology transfer and process implementation.
Develops and contributes to technical documents, including tech transfer protocol and report, GxP protocol and study report, SOPs, and master batch records.
Monitor process performance and assist with trend analysis to identify opportunities for optimization and continuous improvement.
Work collaboratively with Manufacturing, Quality Assurance, Quality Control, Supply Chain, and Process Development teams.
Travel to external manufacturing partners to serve as person-in-plant, train manufacturing operators, and oversee process execution
Practices and promotes safe work habits and adheres to TScan�s safety procedures and guidelines.