Principal Scientist/ Scientific Director - CMCF Novel Cell Therapy

• Provide strategic and scientific guidance in technical areas supporting complex cell manufacturingincluding production of genetically modified cells for investigational clinical trials
• Serve as analytical development expert on biological assays, cellular characterization and functional assaymethod 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
• Support the technology transfer and validation of new clinical-scale cell manufacturing procedures and SOPs for use in clinical research protocols, in collaboration with academic and industry sponsors
• Supervise the training of technical processing staff for each new manufacturing protocol to ensure the ability of clinical processing staff to manufacture clinical products for patients enrolled on the clinical trial
• Manage the project from the initial discussion with the sponsor to handoff to the clinical processing lab
• Responsible for meeting minutes, follow-up on action items, project timelines and communication with sponsor
• Serves as a key subject matter expert on advanced cell therapy practices, procedures, and analysis
• Assists in the development and execution of validation protocols and studies, compilation and analysis of resulting data, and writing final reports
• Reviews validation results against protocol acceptance criteria and consults with Technical Directors to make modifications, as applicable, in collaboration with sponsors, investigators and quality assurance staff to meet regulatory and contractual requirements
• Works collaboratively with faculty investigators, quality assurance staff, industry sponsors and regulatory officials to produce information for IND submissions and other FDA filings
• May prepare and submit data for preparation of manuscripts or other scientific presentations

• Ensure that Technology Transfer staff work under GTP and GMP regulations, provide support, training, review, and competencies assessments, as needed
• Works with other Director’s to schedule product processing, testing, and staffing requirements.
• Assesses the staffing needs to meet the operational needs of the department
• Works with CMCF and DFCI administration on developing a retention program based on established career ladder and individual goals of employees
• Works with CMCF Administration and Human resources for employee counseling and progressive discipline processes as warranted. Prepare internal reports and summaries of NCT projects and manufacturing activities
• Supervise implementation of electronic manufacturing system (L7) for NCT staff and NCT procedures

• Participates in procedures to ensure compliant operations at all levels and functional areas, including technical and scientific conduct, employee safety, financial integrity, human resources management and competencies, quality assurance and ensuring an “inspection ready” laboratory, always
• Participates in monitoring sponsors documents to ensure alignment with working and approved procedures and minimize practice deviation
• Responsible to review and approve documents, batch records, data and product outcomes during technology transfer
• Works with the Administration and QA team to respond to events, propose and initiate corrective action and monitor for compliance with corrective action plan
• Participates in activities to ensure compliance with requirements of all applicable regulatory and accrediting entities including but not limited to FDA, JC, CLIA, CAP, AABB, FACT, CMS, DPH, always collaborating closely with quality assurance staff

• Participate as a member of the executive leadership team for the CMCF
• May participate in gathering information about novel projects and accomplishments for each renewal of the DF/HCC comprehensive cancer center support grant, CMCF website and other annual reports such as FDA annual reports
• Participate in the development and implementation of strategic and business plans within CMCF including implementation of computerized systems

• Participates in developing budgets for new Tech Transfer projects and RFPs
• Participates in evaluating and recommending the acquisition of capital equipment by developing business plans that address growth of current services and/or new opportunities
• Participates in managing equipment and space, construction/renovation, site preparation and installation by planning and coordinating with internal and external parties to complete projects within established timelines and approved budgets
• Assists with managing supply levels by working with materials management to assure supply availability and control costs

• Develops an open and ongoing communication with the department and sponsors
• Creates and maintains a learning environment that facilitates development of staff, colleagues and students
• Participates in professional and educational activities to promote self-development and continued learning

• Ph.D. in Biochemistry, Cell Biology, Molecular Biology, Virology, Biological Sciences or related disciplinerequired
• 10 years relevant experience in investigational and clinical cellular therapy required

• Experience with regulatory submission writing and review required
• Proven experience in support of creating a diverse and inclusive workforce in all aspects of their work andleadership required

Dana-Farber Cancer Institute