We are seeking an experienced and motivated Director for Cell Therapy Development & Manufacturing to be the key Scientific Leader for the CMC development of a novel personalized neo-antigen based T-cell therapy. This leader will drive the development and execution of the CMC plan with Contract Development and Manufacturing Organizations (CDMO). The specific goals are technical development of cell activation, expansion, sorting, cryopreservation, and associated analytics such as cell phenotyping, viability/count. Additionally, the leader will be responsible for GMP transfer and development of CMC sections for the IND.
The ideal candidate will have a Ph.D. with multiple years of industry experience in cell therapy development or biologics clinical development and commercialization. The candidate will have strong hands-on technical experience in cell culture process development as well as some experience in T-cell technical development. This is an exciting opportunity to enable novel life-saving cancer therapy development with an opportunity for innovation, professional growth, and a key role in driving company success.
Develop technical CMC development strategy including cell activation, expansion, sorting, harvest/ cryopreservation, and analytical development of relevant technologies.
Act as principal technical lead and provide oversight for technical and scientific interactions with CDMO and analytical vendors.
Collaborate efficiently and effectively with program team and across other Pharm Sci & Mfg groups to advance CMC activities. Work with supply chain and other technical leads for supply chain development.
Contribute to manufacturing strategy development, GMP readiness, technology transfer, capacity planning and clinical/commercial planning.
Develop CMC regulatory sections and lead discussions with regulatory agencies for technical meetings.
Breadth of knowledge across cell therapy technologies, cell therapy manufacturing, cell characterization method development for T-cells or other primary cultures or stem cells.
Understanding of process development/qualification and GMP manufacturing of cell therapy and use of closed-systems, single-use or disposable technology for sterile and aseptic processing applications.
Working knowledge of flow cytometry, ELISAs, cell-based assays, and compendial methods for cell and gene therapy. Knowledge of chromatographic/mass spec methods is a plus.
Strong knowledge of global cGMPs and CMC regulatory framework for advanced therapies such as gene and cell therapy regulations.
Demonstrated track record of success in delivering on clinical development
Experience managing and mentoring scientists at contract or in-house laboratories.
Excellent organizational, management, communication and interpersonal skills. Ability to drive development through managing priorities, exerting influence, and driving decision making in a fast-paced team environment.
A strong work ethic and sense of purpose with a demonstrated ability to identify, analyze and solve problems.
Willingness for up to 20% travel.
Education and Experience Required
Ph.D. in Life Sciences or Chemical Engineering.
8+ years industry experience in cell therapy and/or biologics operations
5+ years’ experience in managing contract organizations for development or manufacturing activities
*in-house recruiting only*