The Scientific Director of the Novel Cell Therapy Lab is responsible for developing, directing, and coordinating the manufacturing of investigational cell therapy products for the Connell and O???Reilly Families Cell Manipulation Core Facility (CMCF) at DFCI. Aside from overseeing both day to day clinical manufacturing, this position is responsible for developing and implementing new initiatives, overseeing program operations including program planning and evaluation, data review and analysis, and overall management of the Novel Cell Therapy (NCT) lab within the CMCF.
The Scientific Director works directly with other key leaders within the Novel Cell Lab; the Assistant Technical Director, Technology Transfer Director and Research and Development Director to support the transition of new projects and process development of new cellular products in collaboration with academic and company sponsors.?? This Director will work with the Business Director to establish budgets for manufacturing and testing and work with the other director(s) to ensure the processes and documents meet regulatory and accreditation requirements. The position works closely with senior executives, IND sponsors and key investigators internal and external to DFCI.
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
Provide strategic and scientific guidance in technical areas supporting complex cell manufacturing including production of genetically modified cells for investigational clinical trials.
Serve as analytical development expert on biological assays, cellular characterization and functional assay method development and validation, and establishment of specifications for investigational products.
Guide teams in the preparation of technical documents and regulatory submissions, participating in their review and approval, and contributing to development of strategies to comply with US and international regulatory standards
Provide scientific guidance on complex manufacturing investigations
Lead discussions to identify new scientific/technical opportunities.
Promote strong partnerships with internal academic investigators and external sponsors to promote the development of novel cellular products and new clinical trials.
PhD. in Biochemistry, Cell Biology, Molecular Biology, Virology, Biological Sciences or related discipline is required
At least 10 years relevant experience in investigational and clinical cellular therapy
Experienced expert in development of immuno-oncology therapies, vaccines, and/or cell and gene therapy with demonstrated track record of successful development programs and regulatory compliance
Demonstrated ability to develop, qualify/validate and transfer biologics analytics into manufacturing processes and product testing that meet clinical needs
Broad knowledge of the industry, including in-depth operating knowledge of the processes and functions involved in cell & gene therapy and vaccine development and life cycle management is required
Experience with regulatory submission writing and review is required
Ability to influence without authority in a matrix organization is required
Candidates must possess excellent oral and written communication skills
Demonstrated ability to be self-motivated and make difficult decisions in a timely fashion
Strong problem-solving and organizational skills are required
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong.?? As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff.?? Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to under-served members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.