Manager, CMC Operations

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 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, 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:

• Act as the CMC Operations Lead to manage complex program projects including but not limited to external drug substance and critical intermediate manufacturing, CMC regulatory filings, overall development program material forecasting, as well as strategic initiatives.
• Act as primary contact for CMO business collaborations, ensuring the overall relationship between TScan and CMOs is healthy. Proactively direct the resolution of issues.
• Align internal and external functions to ensure clarity on needs, timelines, and milestones.
• Support development and management of contracts including MSAs, SOWs, Change Orders, POs, etc.
• Lead cross-functional teams comprised of internal and external subject matter experts to meet business, operations, and quality objectives and ensure successful supply availability from CMOs.
• 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.
• Communicate key issues, production status, and highlights of activities.
• Help create annual CMO budget and monitor performance against plan.
• Fosters high performance teamwork, establishes strong working relationships with key stakeholders, and demonstrate personal ownership and accountability for results with a focus on customer service.
• May serve as Project Leader for critical internal projects.
• Contributes to the best practices of CMC operations to support the continued success and evolution of the broader CMC organization.
• Develop and manage the specific project schedule, meetings, deadlines, minutes.
• Provide substantial input to internal PM tools including driving changes to current plan and optimizing.
• Monitor and track the critical path items.
• Ensure that risks are identified and managed, implementing effective risk responses to minimize/better predict the project's potential delays.

Requirements:

• BS/MS in Life Sciences preferred, with at least 5 years of technical operations experience within the biopharmaceutical or pharmaceutical industry.
• Experience with early phase drug development as well as program/project management preferred.
• Experience managing external CMOs/CDMOs
• Understanding of CMC development, regulatory CMC requirements, and cGMP compliance.
• Must be detail oriented and organized but also able to be an active member of the project team and think strategically.
• Experience in managing complex projects / technical teams internally and/or 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 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.