Reporting to the Medical Director, Executive Medical Director, and the Senior Administrative Direct, 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 Director, Technology Transfer Director and Process Development Director to support the transitionof 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.

The incumbent in this position will oversee the technology transfer for a new manufacturing process from a sponsor for an investigational product and ongoing investigationsl cell therapy manufacturing within NCT. Responsibilities include:

Technical Responsibilities
•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

Laboratory management
• 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

Compliance
• 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

Planning and resource management
• 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

Fiscal Management
• 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

Communication
• 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
  5 years of management experience in a cellular therapy lab required
• Experienced expert in development of immuno-oncology therapies, vaccines, and/or cell and gene therapywith demonstrated track record of successful development programs and regulatory compliance 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

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

Knowledge of flow cytometry, molecular biology, genetic engineering
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
Ability to influence without authority in a matrix organization
Demonstrated ability to be self-motivated and make difficult decisions in a timely fashion
Strong problem-solving and organizational skills
Working knowledge of FDA (cGTP and cGMP), AABB, FACT, CLIA, JC, and DPH regulations regarding laboratory procedures
Strong leadership skills and experience working in teams
Strong work ethic, positive attitude, team-centered mentality
Outstanding interpersonal skills and excellent verbal and written communication skills

Leadership qualities: strategic thinker with an orientation for action and results, creative, responsive, able to plan and execute effectively with a profound attention to detail
Demonstrated effectiveness in accomplishing objectives in a complex organization
Demonstrated professional behavior and relationship skills and maintenance of confidential information especially when working outside vendor/sponsor contract
Ability to manage complex issues and make decisions with widespread implications
Ability to be a leader that others can learn and develop from and who actively engages in the attraction, development and retention of talent

SUPERVISORY RESPONSIBILITIES:
Directly oversees NCT Technical Director, Technology Transfer Director and Process Development Director. Works in close collaboration with Technical Directors of processing labs and CTTL

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 characteristics protected by law.

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