Manufacturing Technical Lead

2 months ago


Waltham, United States TScan Therapeutics Full time
Job DescriptionJob 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 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 requirements

Requirements:

  • 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 job

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.

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.



  • Waltham, Massachusetts, United States Nova Biomedical Full time

    Job SummaryNova Biomedical is seeking a skilled Manufacturing Process Engineer II to support the daily technical activities of planar sensor manufacturing.Key Responsibilities:Provide technical support to planar sensor operations, investigating and resolving issues that arise during manufacturing/processing.Measure and inspect components for form, fit,...


  • Waltham, Massachusetts, United States Vicarious Surgical Full time

    Job OverviewVicarious Surgical is seeking a Lead Manufacturing Test Engineer to enhance our engineering team. In this role, you will be tasked with the creation, validation, and execution of manufacturing testing methodologies and protocols to guarantee that our robotic systems adhere to the highest quality and performance benchmarks.As a pioneering robotics...


  • Waltham, United States Nova Biomedical Full time

    Nova Biomedical is hiring a Manufacturing Process Engineer II on-site in our Waltham, MA facility. This individual will support the daily technical activities of planar sensor manufacturing. This includes developing and optimizing manufacturing processes to achieve increased output, quality and cost goals of the organization. Collect and production data and...


  • Waltham, Massachusetts, United States Nova Biomedical Full time

    Job SummaryNova Biomedical is seeking a highly skilled Manufacturing Process Engineer II to support the daily technical activities of planar sensor manufacturing.Key Responsibilities:Technical Support: Provide day-to-day technical floor support to planar sensor operations, investigating and resolving issues that arise during manufacturing/processing.Quality...


  • Waltham, Massachusetts, United States Boston Dynamics Full time

    We are seeking an experienced Software Developer to act as Tech Lead and Manager for the new Atlas Applications team. In this role, you'll be responsible for building out the application software which turns the amazing Atlas robot into a complete solution for our customers. The technical scope covers Human-Robot Interaction, AI interactions, advanced UI,...


  • Waltham, United States Pivotal Solutions Full time

    Consumable and Reagent Manufacturing Floor Manager Responsibilities:Plan, organize, direct and run multiple manufacturing lines.Responsible for production output, product quality and on-time delivery of finished goods to stock.Allocate and effectively utilize resources to drive delivery with minimal scrap.Follow all safety and maintenance procedures.Manage...


  • Waltham, United States Pivotal Solutions Full time

    Consumable and Reagent Manufacturing Floor Manager Responsibilities:Plan, organize, direct and run multiple manufacturing lines.Responsible for production output, product quality and on-time delivery of finished goods to stock.Allocate and effectively utilize resources to drive delivery with minimal scrap.Follow all safety and maintenance procedures.Manage...


  • Waltham, Massachusetts, United States Evident Scientific Full time

    Position OverviewThe role of the Advanced Manufacturing Engineer is pivotal in navigating the daily challenges of a dynamic production environment while meeting operational goals. Company: Evident ScientificAbout Us: At Evident Scientific, we are dedicated to enhancing the quality of life through innovative solutions in the life sciences and industrial...


  • Waltham, Massachusetts, United States ZoomInfo Technologies LLC Full time

    Job OverviewAt ZoomInfo Technologies LLC, we foster an environment that encourages innovation, values teamwork, and emphasizes accountability. We are committed to helping you unlock your potential and thrive in your career.We are currently seeking an experienced Senior Technical Program Manager to join our Strategic Programs Technical Project Management...


  • Waltham, Massachusetts, United States ZoomInfo Full time

    Become a Key Player at ZoominfoAre you an experienced leader in technical program management? Zoominfo is seeking a Senior Technical Program Manager to spearhead cross-departmental initiatives and ensure the achievement of enterprise and product objectives. In this pivotal position, you will strategize, organize, and implement technical programs while...


  • Waltham, Massachusetts, United States NanoMosaic Full time

    Position OverviewSalary: CompetitiveNanoMosaic Inc. is at the forefront of pioneering photonics technology aimed at advancing biomedical research, diagnostics, companion diagnostics, and pharmaceutical development. Our innovative solutions are designed to push the boundaries of medical research, particularly in the ultra-sensitive detection of single...


  • Waltham, Massachusetts, United States NanoMosaic Full time

    Position OverviewSalary: CompetitiveNanoMosaic Inc. is dedicated to pioneering advanced photonics technology aimed at biomedical research, diagnostics, companion diagnostics, and pharmaceutical development. Our innovative solutions are set to revolutionize medical research through the ultrahigh-sensitivity detection of single molecules in minimal volume...


  • Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Job SummaryThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is a critical role at Dyne Therapeutics, responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key ResponsibilitiesLead CMC regulatory execution for specific programs at all stages of...


  • Waltham, United States Nova Biomedical Full time

    Career Opportunities with Nova Biomedical Corporation Nova Biomedical is an Equal Opportunity Employer in compliance with Affirmative Action in hiring and promoting women, minorities, veterans, and individuals with disabilities. Nova Biomedical is hiring an SMT Manufacturing Engineer on-site in our Waltham, MA facility to provide technical engineering...


  • Waltham, United States NanoMosaic Full time

    Job DescriptionJob DescriptionSalary: NanoMosaic Inc., located in Waltham, Massachusetts, is focused on developing innovative photonics technology for biomedical discovery, Dx, CDx, and drug development. Our cutting-edge technology will enable new frontiers of medical research for ultrahigh-sensitivity detection of single molecules in low volume liquid...


  • Waltham, United States Zenasbio Full time

    Sr. Director, Biologics Drug Substance Development and Manufacturing Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune–based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio...


  • Waltham, Massachusetts, United States NanoMosaic Full time

    Position OverviewSalary: CompetitiveNanoMosaic Inc. is dedicated to pioneering advanced photonics technology aimed at enhancing biomedical research, diagnostics, companion diagnostics, and pharmaceutical development. Our state-of-the-art innovations facilitate unprecedented medical research capabilities, particularly in the ultra-sensitive detection of...


  • Waltham, Massachusetts, United States Nano Dimension Full time

    About the Role:Become a vital member of Nano Dimension as a Technical Support Engineer for North America, working alongside a skilled team of experts. Nano Dimension is at the forefront of innovation, specializing in the design and production of advanced Paste Jetting, SMT Placement, and Dispensing equipment for diverse sectors including Automotive,...


  • Waltham, Massachusetts, United States ElevateBio Full time

    About the RoleElevateBio is a cutting-edge biotechnology company that is revolutionizing the field of cell and gene therapy. We are seeking a highly skilled and experienced individual to join our team as a Supervisor, Cell Therapy Manufacturing Specialist.Key ResponsibilitiesLead the manufacturing operations team at our state-of-the-art facility, ensuring...


  • Waltham, United States Vicarious Surgical Full time

    Job DescriptionJob DescriptionVicarious Surgical is hiring a Senior Manufacturing Test Engineer to join our team in Waltham, MA. You will be responsible for developing, validating and implementing manufacturing test methods and procedures to ensure that our robotic systems meet the highest standards of quality and performance. You will work closely with...