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 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.

RESPONSIBILITIES:

• Leads, designs, and executes laboratory-based process development studies in the pilot plant supporting the tech transfer of new equipment and processing steps into GMP manufacturing.
• Leads and executes at-scale end-to-end runs in the pilot plant to demonstrate process manufacturability and generate materials in support of CMC activities.
• Lead technology transfer to TScan’s internal manufacturing facility by collaborating with cross-functional teams (Manufacturing, Process Development, Analytical Development, Quality, CMC Ops, etc.)
• Develops and reviews manufacturing process SOPs, master production records and process performance qualification/process validation protocols.
• Serves as the primary MSAT SME in support of internal GMP manufacturing; facilitate manufacturing decision-making, problem-solving by providing on-site tech support.
• Performs hands on laboratory training with manufacturing staff and serves as the manufacturing process SME during technical transfer.
• Utilizes manufacturing process knowledge and investigation skill sets to investigate and resolve manufacturing issues, improve process unit operations and affect positive change.
• Manages the routine operation of the pilot plant by interfacing with Manufacturing, Supply Chain, and Facility teams.
• Regularly provides progress reports, technical reports, and other status updates to the CMC and Technical Operations leadership teams.
• Practices and promotes safe work habits and adheres to TScan’s safety procedures and guidelines.

REQUIREMENTS:

• Advanced degree (PhD, MS, or BS) in Biology, Immunology, Biochemistry, Biochemical Engineering, or related degree with experience (2+ for PhD, 5+ for MS, 8+ for BS) in process development and manufacturing sciences in cell therapy, biotechnology, or pharmaceutical industry
• Hands-on experience with equipment used for T cell therapy manufacturing is required: Rotea, G-Rex (closed system), Prodigy, LOVO, Sepax, CRF, etc.
• Extensive lab-based experience with aseptic processing, cell culture, cell therapy manufacturing is required.
• Experience with genetic material delivery by electroporation is preferred.
• Industry experience in manufacturing process technical transfer, risk assessments, technical operations, and quality systems interfacing a GMP environment are highly preferred.
• Working knowledge of analytical testing for cell therapy manufacturing, such as flow cytometry and PCR, is preferred.
• Knowledge of Immunology or Immune-oncology, especially T cell biology, is desired.
• Knowledge of GMP regulations and ICH/quality guidelines related to cell therapy manufacturing.
• Excellent communication and interpersonal skills.
• Highly organized with immense attention to detail.
• Demonstrated effective collaboration and communication with laboratory and manufacturing staff.

About TScan:

TScan Therapeutics is a fully integrated, next-generation TCR-T cell therapy company. Founded in 2018, TScan’s platform was developed by Stephen Elledge, Ph.D., and Tomasz Kula, Ph.D., at Brigham and Women’s Hospital and Harvard Medical School. TScan’s 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 70,000 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 and/or to perform the responsibilities of the position for which the applicant has applied, please contact the recruiter.

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.