Manufacturing Associate II

We are hiring Manufacturing Associate I-II 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 or biologics 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.

This role is on-site and will follow a shift schedule. Roles will train on a Monday – Friday schedule before transitioning to rotating day shifts (including weekends) for operations.

• 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
• Maintain cleanliness and orderliness of process area, ensuring production area is stocked with supplies
• Participate in batch record review, procedure revisions, and bill of materials
• 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

• High School Diploma or GED required, at minimum;
  Bachelor’s degree preferred
• 2‑4+ years of experience in cGMP manufacturing in the biotech or pharmaceutical industry
  • Prior cell therapy manufacturing experience highly preferred, advanced biologics required in lieu of CT
• 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

$95,000 – $122,500

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.