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 operations lead to join our team as Manager, CMC Operations, supporting our novel target identification and validation workflow in house. The ideal candidate should have relevant experience in project management, product development, CMC team management and facilitation including agendas, minutes, project tracking, and budgeting, and enjoy fast-paced, collaborative and vibrant startup culture. A team player with a sense of urgency will thrive in this role.

Responsibilities:

• Manage complex product development projects as the CMC Operations lead, including but not limited to external cellular drug product and critical raw material manufacturing, CMC program planning, and strategic CMC development initiatives.
• Ensure the CMO relationship is healthy and goals are achieved as the primary contact with CMOs. Proactively facilitate and resolve issues related to the collaboration.
• Lead cross-functional meetings comprised of internal and external subject matter experts organized to ensure supply availability from CMOs.
• Support development and management of contracts including MSAs, SOWs, Change Orders, and Purchase Orders.
• Proactively identify risks (business, technical, quality, etc.) with internal and external teams. Create and ensure execution of mitigation plans.
• Identify metrics and drive performance improvements with CMOs.
• Communicate key issues, production status, and highlights of activities to leadership.
• Create CMO budget and track performance against plan.
• Foster high performance teamwork, establish strong working relationships with key stakeholders, and demonstrate personal ownership and accountability for results.
• Contribute to the best practices, processes and tools of CMC operations to continuously improve the broader CMC organization.
• Develop and manage project schedules, meetings, deadlines, and meeting minutes.

Requirements:

• BS/MS in Life Sciences preferred, with at least 5-10 years of technical operations experience within the biopharmaceutical industry.
• Industry experience in cell therapy development preferred.
• Experience managing external CMOs/CDMOs required.
• Experience with late phase CMC product development as well as program/project management preferred.
• Understanding of CMC development, regulatory CMC requirements, and cGMP compliance.
• Must be detail oriented and organized but also ability to think strategically as an active member of the project team.
• Experience in managing complex projects / technical teams internally and externally.
• Ability to work with CMC team members to foster a positive team culture of ownership and accountability.
• Demonstrated history of aligning best practices across workstreams by developing standard reporting tools, metrics, agendas, minutes, and meeting structures.
• Ability and desire to work under pressure and tight deadlines while maintaining quality relationships and data.
• Strong interpersonal, organizational and communication skills.
• Successful track record of both internal and external relationship management.

About TScan:

TScan Therapeutics is a fully integrated, next-generation TCR-T cell therapy company. Founded in 2018, TScan’s platform was developed by Stephen Elledge, Ph.D., and Tomasz Kula, Ph.D., at Brigham and Women’s Hospital and Harvard Medical School. TScan’s transformative platform enables rapid discovery of TCRs and targets for engineered T cell therapy. This technology is extremely versatile and is applicable across multiple therapeutic areas beyond cancers, including autoimmune disorders and infectious diseases.

Do YOU have the anatomy of a TScanner?

Our talented, compassionate, and intelligent team is what makes TScan a Top Place to Work (as ranked by The Boston Globe). Our state-of-the-art offices with over 70,000 square feet of premium lab space, including an internal GMP manufacturing suite, are an environment that supports innovation, camaraderie, and professionalism. We are passionate, fun, flexible, and team oriented. Sound like you? Apply today.

EEO Statement

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.

Recruitment & Staffing Agencies

TScan Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to TScan Therapeutics or its employees is strictly prohibited unless contacted directly by TScan Therapeutics’ internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of TScan Therapeutics, and TScan Therapeutics will not owe any referral or other fees with respect thereto.