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    Manufacturing Supervisor - Waltham, United States - TScan Therapeutics

    TScan Therapeutics
    TScan Therapeutics Waltham, United States

    2 weeks ago

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    Description

    Job Description

    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 manufacturing professional to join our team as a Manufacturing Supervisor. The ideal candidate should have extensive experience in a cGMP Manufacturing cleanroom environment, demonstrated prowess in cell therapy manufacturing, prior supervisory experience, and enjoy fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.

    Responsibilities:

    • Lead cGMP manufacturing of TScan cell therapy products while adhering to cGMPs, SOPs, compliance/regulatory mandates, safety procedures, and quality requirements
    • Provide hands-on technical, organizational, and leadership expertise to the manufacturing department
    • Train, coach, and development 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.
    • Generate and manage batch records, run reports, batch data, etc. for manufacturing and scale-up activities.
    • Maintains cleanliness and orderliness of process area, ensuring production area is stocked with supplies
    • Utilizes manufacturing knowledge to improve process operations and assists the identification and implementation of continuous improvement opportunities
    • Supports in and or leads in Commissioning and Validation activities
    • Assists in the creation and revision of manufacturing documentation by providing input to technical composition of document
    • Maintain equipment operation through responsive troubleshooting, repairs and following operations guidelines
    • Document all production efforts in appropriate logs, forms, reports, and databases
    • Identifies and assists in the corrective actions of processing related issues

    Requirements:

    • High School Diploma or GED required, at minimum
    • 8-10+ years of experience in cGMP manufacturing in the biotech or pharmaceutical industry required
    • 3-5+ years of prior people management experience in a manufacturing setting
    • Prior cell therapy manufacturing experience highly desired
    • Must be able to read, write, and speak English fluently
    • Experience in reviewing and creating controlled documents
    • After safety training, must be able to perform required tasks in fully compliant manner
    • 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

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