Director-Cell Therapy Laboratory, Full-Time, Days

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Director
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0052369 Requisition #
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The Director, Mathews Center for Cellular Therapy (MCCT) reflects the mission, vision, and values of NM, adheres to the organization’s Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.

 

The Director, MCCT directs all activities within the Northwestern Medicine cell processing laboratory, and the cell manufacturing laboratory.  Further, the Director is responsible for all administrative operations, quality assurance and provides leadership for the development and implementation of all cell-processing procedures within the laboratories including compliance with applicable regulating bodies. 

 

Description
  • Directs all operating procedures, administrative operations, validation studies and the quality management program of the cell processing and cell manufacturing laboratories in compliance with FACT, CAP, CLIA and FDA regulations.  Must have proven proficiency with GTP, GLP, GMP and GCP.
  • Collaborates with the Medical Director with establishing and defining goals, objectives, and operational plans that support the scientific and clinical goals and objectives as they relate to advancing Cellular Therapy for the treatment of malignant and non-malignant disease.
  • Develops relationships with cell therapy and biotech corporate entities to promote and establish them as clients of the GMP manufacturing facility
  • Directs the day-to-day activities of the laboratory and is actively involved in reviewing and improving operational procedures in the laboratory. Analyzes workflow and recommends methods for effective and efficient operation.
  • Directs program budget development and implementation; prepares and implements development of clinical trial budgets, manufacturing budgets and grant services budgets.
  • Serve as an expert, utilizing scientific knowledge and professional judgment in the design, implementation, and analysis of biologic product manufacturing.
  • Direct processing and manufacturing activities and evaluates the integrity of processes and quality of products by monitoring safety, purity, potency, accuracy, and precision.
  • Establishes project plans and timelines for process development, process technology transfer and GMP manufacturing for T cell therapy development projects.  Works with investigators and assists in the preparation of investigator initiated IND.
  • Oversees appropriate completion of all components of laboratory operation including: standard operating procedures, validation procedures, document control and record keeping, reports of adverse reactions, accidents, deviations/variances and corrective action plans.
  • Determines need for new or updated methodology, and directs development and validation of new methods of production, associated quality control assays, and all associated standard operating procedures (SOP), master process records and staff training programs. AA/EOE
Required:
  • Doctoral Degree in relevant scientific field
  • 2 years of formal post-doctoral training in stem cell processing
  • 3 to 5 years of experience with GTP, GLP and GMP regulations and compliance activities.
  • Experience with human hematopoietic stem cell processing and manipulation
  • Experience with the Foundation for the Accreditation of Cellular Therapy (FACT) accreditation process for cellular labs.
  
Preferred:
  • Established network in cell therapy or biotech industry.

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