LOCATION: Waltham, MA
TScan Therapeutics is a well-funded, startup biotech seeking to revolutionize life- changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced professional working with External Manufacturing and Contract Manufacturing Organizations (CMOs) to join our team supporting our novel target identification and validation workflow in house. The ideal candidate should have relevant experience in Supply Chain and External Manufacturing/CMO within Biotech/Pharma, and enjoy fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.
General Responsibilities: In this hands-on role you will have the ability to develop, build, shape, and implement strategies by leading with key Contract Manufacturing Organizations (CMOs) by both internal and external cross-functional teams.
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.
Responsibilities include, but are not limited to:
- Manage relationships with key External Manufacturers and CMOs by building and leading cross-functional teams to ensure delivery of program milestones.
- Lead External Manufacturers and CMO’s deliverables in alignment with corporate objectives.
- Responsible for operational and technical assessment of potential manufacturing partners and provides input into partner selection.
- Provide support for external process development and manufacturing for external manufactured product.
- Ensure timely routing and review of all master batch records and deviation reports.
- Ensure appropriate person-in-plant oversight for critical operations as required and subject to COVID safety policies.
- Monitor External Manufacturers and CMO’s capacity based on projected TScan needs. Work with partners to mitigate continuity of supply risk.
- Support required documentation and movement of material at all external storage locations. Support master data set up and required documentation for on-going maintenance and new item set up.
- Reconcile inventory across all external storage locations basis and issue consolidated monthly inventory reports.
- Manage ongoing External Manufacturers and CMO’s relationships including implementing KPIs/metrics, business review meetings, and contract compliance.
- Develop scopes of work and contributes to contracts and program budgets for external programs.
- Provide input to budget/forecast and generate accruals monthly.
- Oversee external cGMP operations in compliance with cGMPs and internal SOP’s and other procedures.
- Communicate progress versus plan and escalates issues as needed.
- BS/MS and 15+ years’ experience in the Life Sciences, Engineering, Business, Supply Chain, or related areas within Biotech/Pharma.
- Experience managing External Manufacturing and/or Contract Manufacturing Organizations strongly preferred.
- Strong interpersonal skills, combined with project and team leadership skills.
- Ability to act in a complex and rapidly changing business environment.
- Working knowledge of product development and GMP Manufacturing.
- Ability to prioritize, manage time well, multitask, troubleshoot.
- Ability to effectively communicate with a broad spectrum of people having varying backgrounds, education, and experience.
- Demonstrated success in delivery of key milestones against tight timelines.
- Strong organizational and computer (Microsoft Word, Excel, PowerPoint, Adobe Acrobat) skills required.
- Ability to communicate clearly with a variety of individuals in various aspects of TSCAN operations.
- Detail-oriented with expertise in problem solving and solid decision-making abilities.
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 are an environment that supports innovation, camaraderie, and professionalism. We are driven, passionate, fun, flexible, and team oriented. Sound like you? Apply today.