• Technical Director - Cell Manipulation Core Facility Process Development

    Location US-MA-Boston
    Job Posted Date 2 months ago(8/21/2019 11:46 AM)
    Job ID
    2019-16684
    Category
    Medical Technologist/Clinical Lab
    Type
    full time
    Grade
    24
  • Overview

     

    The Technical Director of the Process Development Lab is a key leadership position that provides technical expertise, analytical capability, strategic planning and project management support. The Process Development Laboratory within the Connell O’Reilly Cell Manipulation Core Facility (CMCF) at DFCI is responsible for development of investigational cell-manufacturing procedures and test methods, working with sponsors and investigator to ensure a seamless transition during scale up, process improvement and technology transfer prior to clinical manufacturing.

     

    This position reports into Administrative Director and Executive Medical Director and works closely with the other CMCF leadership to establish standard processes, create budgets for manufacturing, and documents for each new process. 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 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 underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

     

     

    Responsibilities

    The incumbent in this position will be responsible for all aspects of bringing new processes and technologies and testing methods into the Cell Manipulation Core Facility (CMCF).

     

    Responsibilities include:

     

    Technical Responsibilities:

    • Oversees investigational manufacturing and analysis of all cellular therapy products in the Research and Development Lab
    • Serves as a key subject matter expert on advanced cell therapy practices, procedures and aseptic techniques.
    • Works with academic investigators and industry collaborators to develop new clinical-scale cell manufacturing procedures and SOPs for use in clinical research protocols.
    • Develops, manages and coordinates validation protocols, execution of validation studies, data analysis, and the compilation of the validation data and results into final reports. The summary of these results is often critical in the filing of IND/IDE submissions.
    • Serves as customer liaison for sponsored projects involving novel cellular product development and manufacturing. This may entail orchestrating multidisciplinary meetings with sponsors, summarizing data, and constructing action plans and timelines.
    • Reviews validation results against protocol acceptance criteria and makes modifications as applicable in collaboration with sponsors, investigators and quality assurance staff to meet acceptable release criteria.
    • Works collaboratively with faculty investigators, quality assurance staff, industry sponsors and regulatory officials to produce information for IND submissions and other FDA filings.
    • Continually monitors and updates current production methods and laboratory management policies to be consistent with current best practices as reported in the relevant scientific literature
    • Prepares and submits data for preparation of manuscripts or other scientific presentations
    • Represents the CMCF in the cellular therapy field, internally and externally through participation in research and leadership activities at the national and international level

    Laboratory management

    • Ensures that new processes are developed to be incompliance with GTP and GMP regulations, providing optimal support, training, review, competencies assessments, productivity and performance excellence.
    • Working with directors, manager and supervisors to schedule cross training for the clinical manufacturing and CTTL staff.
    • Responsible for timely staff performance evaluations using established appraisal tools to assess competence and formulate professional and personal development plans.

    Compliance

    • Ensures 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
    • Collaborates with the leadership team to initiate new documents.
    • Works with the Laboratory Manager, Supervisors and QA team to respond to events, propose and initiate corrective action and monitor for compliance with corrective action plan.
    • Ensures that new processes that are being developed are compliant with requirements of all applicable regulatory and accrediting entities including but not limited to FDA, JC, CLIA, CAP, AABB, FACT, CMS, DPH, collaborating closely with quality assurance staff at all times

    Planning and resource management

    • Serves as a member of the executive leadership team for the CMCF
    • Assists 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
    • Plays a key role in the development and implementation of strategic and business plans within CMCF

    Fiscal Management

    • In conjunction with the CMCF leadership assist in developing operating budgets using established accounting principles to maximize revenue and minimize expense.
    • Evaluates and recommends the acquisition of capital equipment by developing business plans that address growth of current services and/or new opportunities.
    • Manages 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.
    • Manages supply levels by working with materials management to assure supply availability and control costs.

    Communication

    • Develops an open and ongoing communication with the department, Institute staff and trial 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.

    SUPERVISORY RESPONSIBILITIES:

     

    Provides direction to staff that rotate into the R&D area for a given project. This is done in collaboration with both the NCT Technical Director and Managers.

    Qualifications

    MINIMUM JOB QUALIFICATIONS:

    • Bachelor's degree required. Doctoral degree in a biological science or medical field highly desirable. Must meet the minimum CLIA requirements for supervisor in a highly complex testing laboratory. Knowledge of cell manufacturing, flow cytometry, molecular biology, genetic engineering is highly desirable.
    • This position requires 5 or more years of management experience in a cellular therapy lab, related pre-clinical research laboratory, or related experience in biotechnology or pharmaceutical company also acceptable.
    • Must have knowledge of FDA (cGTP and cGMP), AABB, FACT, CLIA, JC, and DPH regulations regarding laboratory procedures.

     

    KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

     

    This position requires 5 or more years of management experience in a cellular therapy lab, related pre-clinical research laboratory, or related experience in biotechnology or pharmaceutical company also acceptable.

     

    • Must have exceptional 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
    • Strong track record of proactive and responsive risk analysis relative to patient and employee safety
    • Able to toggle between strategy and day to day operations while leveraging the capacity and capability of their team
    • Must be able to function effectively in ambiguous conditions; recognize trends, and identifies systemic approaches to solving problems in a fast-moving, constantly changing environment
    • Track record for exceptional service and creativity in service to complex organizations and demands of clients within such institutions
    • Must have a consultative, relationship building approach and the highest level of professionalism and discretion
    • The ability to communicate and influence effectively “up, down and across” the organization is critical; must be experienced as a collaborator and team player
    • This individual will rely on extensive experience and judgment to plan and accomplish goals
    • Must understand the principles of immunohematology as it applies to cellular therapy.
    • Possess experience of demonstrated effectiveness in accomplishing objectives in a complex organization.
    • Vendor/sponsor contract relationship skills
    • Proven experience in support of creating a diverse and inclusive workforce in all aspects of their work and leadership.
    • Must have experience in managing complex issues and making decisions with widespread implications.
    • Must be a leader that others can learn and develop from and who actively engages in the attraction, development and retention of talent.





    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.

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