What are the responsibilities and job description for the Manager, CMC Operations position at TScan Therapeutics?
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 CMC operations manager to join our team as Manager, CMC Operations, managing CMC activities related to the development and manufacturing of TScans clinical pipeline. The ideal candidate should have relevant experience in CMC product development and project management, and enjoy fast-paced, collaborative, and vibrant culture. A team player with a sense of urgency will thrive in this role.
Responsibilities:
- Establishes and partners with CMC teams to build project timelines, milestones, risk registers and mitigation plans supporting CMC development and manufacturing activities related to TScans clinical pipeline.
- Proactively partners with Process and Analytical Science, Regulatory Affairs, Quality, Manufacturing and Supply Chain teams to ensure alignment of CMC activities with overall project goals.
- Proactively tracks and ensures CMC milestones are delivered on-time, in-full, and within budget, while ensuring compliance and high quality. Identifying and escalating issues as appropriate through appropriate governance bodies, taking full ownership of the process to drive issue resolution.
- Builds and fosters high performing CMC teams by setting clear expectations, coaching team members and providing feedback, support and guidance to ensure that each member is enabled to provide their best performance
Requirements:
- Advanced degree (BS/MS or PhD) in Life Sciences preferred, with at least 5-10 years of technical operations experience within the biopharmaceutical industry.
- Experience managing CMC projects and cross-functional teams responsible for the development and manufacturing of cellular drug products.
- Industry experience in cell therapy development required.
- Strong leadership and team management skills, with the ability to influence cross-functional teams.
- Experience with CMC product development as well as program/project management required.
- Understanding of CMC development, regulatory CMC requirements, and cGMP compliance.
- Excellent communication and presentation skills, with the ability to effectively communicate complex technical information to stakeholders.
- Strong interpersonal, organizational and communication skills.
About TScan:
TScan Therapeutics is a fully integrated, next-generation TCR-T cell therapy company. Founded in 2018, TScans platform was developed by Stephen Elledge, Ph.D., and Tomasz Kula, Ph.D., at Brigham and Womens Hospital and Harvard Medical School. TScans 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.
