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Manfacturing Associate/Senior Associate
4 months ago
Position Summary:
TScan Therapeutics is a startup biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are hiring Manufacturing Associates across all levels to support and drive our internal Cell Therapy Manufacturing. These positions will be based in our cGMP Manufacturing site in Waltham, MA.
The ideal candidates have demonstrated experience in cell therapy manufacturing, have robust knowledge of cGMPs, and enjoy fast-paced, collaborative environments. A team player with a sense of urgency will thrive in this role.
All roles will train on a Monday – Friday schedule and will transition to rotating shifts for operations.
Responsibilities:
Responsibilities include, but are not limited to:
- Execute cGMP manufacturing of TScan cell therapy products while adhering to cGMPs, SOPs, compliance/regulatory mandates, safety procedures, and quality requirement
- Accurately complete appropriate production documentation for all processing steps
- Main cleanliness and orderliness of process area, ensuring production area is stocked with supplies
- Perform batch record review, procedure revisions, and work order generation
- Utilize manufacturing knowledge to improve process operations and assist in the identification and implementation of continuous improvement opportunities
- Assist in the creation and revision of manufacturing documentation
- Maintain equipment operation through responsive troubleshooting, repairs, and following operation guidelines
- Document all production efforts in appropriate logs, forms, reports, and databases
- Identify and assist in the corrective actions of processing-related issues
Requirements:
- High School Diploma or GED required, at minimum
- For Associate level: 1-3+ years of experience in cGMP manufacturing in the biotech or pharmaceutical industry
- For Senior Associate level: 5-7+ years of experience in cGMP manufacturing in the biotech or pharmaceutical industry
- Prior cell therapy manufacturing experience required
- 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 a 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
- Demonstrated success in delivery of key milestones against tight timelines
- Ability to prioritize, manage time well, multitask, troubleshoot
- 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.
