Technical Transfer Director, CMCF - Full-time / Part-time

Job ID:32233
Location:450 Brookline Ave, Boston, MA 02215
Category:Medical Technologist
Employment Type:Full time
Work Location:Onsite:Up to 1 day remote/wk

Overview

Reporting to the Medical Director and the Senior Administrative Director, the Technology Transfer Director provides leadership and technical expertise and oversees the logistical and technical transfer of processing and analytical methods from outside sponsors to Connell O'Reilly Cell Manipulation Core Facility (CMCF) at DFCI. This role is responsible for the project management of this technology transfer to support the manufacturing and analysis of investigational products in the support of DFCI/HCC clinical trials. This role will support process development of new cellular products in collaboration with academic and company sponsors. The Director works with the Business Director to establish budgets for manufacturing and testing and works with the Quality Director to ensure the processes and documents meet regulatory and accreditation requirements. The position also works closely with senior executives, IND sponsors and key investigators internal and external to DFCI.

Responsibilities

• Oversees 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.
• Supervises 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.
• Manages 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.

Qualifications