Manufacturing Technical Lead

1 week ago

Waltham, Massachusetts, United States TScan Therapeutics Full time

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 manufacturing professional to join our team as a Manufacturing Technical Lead.

The ideal candidate should have extensive experience in a cGMP Manufacturing cleanroom environment, a proven track record in authoring and revising controlled documents, demonstrated prowess in cell therapy manufacturing, and enjoy fast-paced, collaborative, and vibrant startup culture.

A team player with a sense of urgency will thrive in this role.

Responsibilities:

Review GMP-executed manufacturing batch records Revision of controlled documents including, but not limited to, SOPs, MBRs, and BOMs Document, input, and upload manufacturing data and production efforts in appropriate logs, forms, reports, and databases Work with the Quality team through owning, investigating, and writing deviations; creating and executing CAPAs; writing and managing Change Controls; authoring out of specification (OOS) and investigation reports Train, coach, and develop Manufacturing Associates Work effectively with cross functional teams, including but not limited to, Process & Analytical Sciences, MSAT, QC, QA, Supply Chain, CMC Operations, Facilities, etc.

Support and/or lead Commissioning and Validation activities Maintain equipment operation through responsive troubleshooting, repairs, and following operations guidelines Provide hands-on technical, organizational, and leadership expertise to the manufacturing department Support cGMP manufacturing of TScan cell therapy products while adhering to cGMPs, SOPs, compliance/regulatory mandates, safety procedures, and quality requirementsRequirements: High School Diploma or GED required, at minimum Bachelor's degree preferred 8-10+ years of experience in cGMP manufacturing in the biotech or pharmaceutical industry required Prior cell therapy manufacturing experience highly desired Skilled in aseptic techniques and processing Proven track record of owning, investigating, and writing deviations, creating and executing CAPAs, and writing and managing Change Controls Strong technical writing and oral communication skills Must be able to lift and transport (using carts or wheelies) packages weighing up to 50 pounds Extensive walking throughout the facility will be required Must be able to use a company-issued computer and have at least intermediate skills in Microsoft Word, Excel, Outlook, and PowerPoint programs needed to perform jobAbout 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.

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 approximately 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.

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