LOCATION: Waltham, MA
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 professional to join our team as a Director of CMC Regulatory Affairs supporting our growing pipeline of TCR T-cell therapies.
The Director of CMC Regulatory Affairs will be responsible for supporting and leading the development and implementation of US, eventually global, CMC regulatory strategies for TScan’s oncology cell therapy products, from preclinical to eventual commercial stages. The Director will oversee the preparation and submission of CMC sections of regulatory dossiers, including INDs, IMPDs, Annual Reports, BLAs, and quality information amendments (as often as needed or requested by Regulatory Agencies), and will interact with regulatory authorities and internal and external stakeholders to ensure compliance with CMC regulations and guidelines. The Director will also provide CMC regulatory guidance and support to cross-functional teams. The ideal candidate should have relevant experience in CMC regulatory activities for investigation cell therapy products in oncology, and enjoy fast-paced, collaborative and vibrant startup culture. An experienced team player with a sense of urgency will thrive in this role.
- Manage planning, preparation, and internal review of CMC documentation for Clinical Trial Applications, IND submissions and amendments, marketing applications, supplements, variations and other communications with regulatory authorities (e.g., briefing documents for meetings)
- Understanding, interpreting and advising teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products
- Attend project team meetings and provide CMC-related regulatory guidance to other functional areas, including Manufacturing, and Quality
- Work closely with stakeholders to define CMC strategy for submissions
- Manage preparation and internal review of Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) Guidance and company standards.
- Manage preparation of responses to health authority comments and questions pertaining to CMC issues
- Perform regulatory impact assessments for change controls.
- Author, review, and compile CMC sections of regulatory submissions, such as INDs, NDAs, BLAs, MAAs, amendments, supplements, variations, and responses to health authority queries.
- Coordinate and communicate with internal and external stakeholders, such as CMC teams, project teams, quality assurance, contract manufacturing organizations, and regulatory agencies.
- Monitor and assess the impact of new or changing CMC regulations, guidelines, and policies on current and future projects.
- Develop and implement CMC regulatory strategies to ensure timely and successful approval of our products.
- Develop and execute global CMC regulatory strategies for oncology cell therapy products in alignment with the company’s objectives and regulatory requirements
- Lead the preparation, review, and submission of high-quality CMC sections of regulatory dossiers, such as INDs, BLAs, amendments, annual reports, and responses to information requests
- Manage interactions and communications with regulatory authorities on CMC-related matters, including participating in meetings, teleconferences, and inspections
- Monitor and assess the impact of changes in CMC regulations and guidelines on the company’s products and processes, and provide timely updates and recommendations to senior management and relevant teams
- Provide CMC regulatory expertise and input to cross-functional teams, such as manufacturing, quality, research, and clinical development, to ensure alignment and compliance with CMC regulatory requirements
- Collaborate with internal and external partners, such as contract manufacturing organizations (CMOs), contract research organizations (CROs), consultants, and vendors, to support CMC regulatory activities
- Manage and mentor CMC regulatory staff and consultants, and provide training on CMC regulatory topics as needed
- Maintain CMC regulatory files and databases in an organized and compliant manner
- Maintain and update CMC regulatory databases and files.
- Perform life cycle management for products.
- Bachelor’s degree or higher in life sciences, pharmacy, chemistry, engineering, or related field
- Minimum of 10 years of experience in CMC regulatory affairs in the biotechnology or pharmaceutical industry, with at least 5 years in a leadership role
- Experience in developing and implementing global CMC regulatory strategies for cell therapy or gene therapy products is highly preferred
- Experience in preparing and submitting CMC sections of INDs, BLAs, and amendments for cell therapy or gene therapy products is required
- Experience in interacting and communicating with regulatory authorities on CMC-related matters is required
- Knowledge of current US and international CMC regulations and guidelines for cell therapy products is required
- Excellent written and oral communication skills, with the ability to present complex information clearly and persuasively
- Strong organizational, project management, problem-solving, and analytical skills, with the ability to work independently and collaboratively in a fast-paced environment
- Ability to travel domestically and internationally as needed
- Ability to work with Project and CMC Team members to foster a positive team culture of ownership and accountability
- Ability to work independently and collaboratively in a fast-paced and dynamic environment
- Ability and desire to work under pressure and tight deadlines while maintaining quality relationships and data
- Experience with early phase drug development for cell therapies and in general
- Understanding of CMC development, regulatory CMC requirements, and cGMP compliance
- Must be detail oriented, organized, and able to be an active member of the project team and think strategically
- Experience in managing complex projects, being part of technical teams internally and/or externally
- Strong interpersonal, organizational and communication skills
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.