Cell Therapy Manufacturing Specialist

Bethesda, Maryland, United States
Nov 22, 2018
Required Education
Bachelors Degree
Position Type
Full time
The Clinical Monitoring Research Program (CMRP) provides cell culture experience to work on innovative Vector Production and T-cell therapies for cancer treatment, and responsible for cell culture media preparation, vector production, and/or cell processing and cell expansion in the cGMP clinical manufacturing facility in support of the National Cancer Institute's (NCI's), Center for Cancer Research (CCR), Surgery Branch (SB).

  • Performs testing of raw materials, intermediates, and final products by following analytical methods
  • Maintains, calibrates and operates equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assay
  • Tracks and tests products according to protocols
  • Maintains lab in an optimal state
  • Monitors and trends data, completes routine record review of test data and related documents for in-process testing, drug substance and drug product release
  • Generates CoAs for product release
  • Assists in the preparation of dossiers and data packages for interactions between Surgery Branch and Regulatory agencies
  • Develops, revises, and reviews SOPs, qualification/validation protocols and reports
  • Participates in investigations regarding out of specifications (OOS) results; address and manage deviations related to analytical procedures
  • Provides updates at daily and weekly meetings
  • Monitors the GMP systems currently in place to ensure compliance with documented policies
  • Reviews proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
  • Gathers metric information for use in continuous improvement of areas of responsibility
  • May develop testing and analysis methods and procedures in accordance with established guidelines
  • This position is located in Bethesda, Maryland

  • Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
  • In addition to educational requirements, a minimum of two (2) years of progressively responsible job-related experience
  • Cell culture processing experience and/or viral vector manufacturing experience
  • Excellent aseptic/sterile techniques
  • Experience with handling and propagation of human primary cells, including T cells
  • Ability to strictly adhere to SOPs and cGMP regulations and accurately complete documentation associated with clinical manufacturing
  • Proficiency in Microsoft Word, Excel and data analysis
  • Ability to think critically and demonstrate strong troubleshooting and problem-solving skills
  • Must be self-motivated and willing to accept temporary responsibilities outside of initial job description
  • Excellent interpersonal, verbal and written communication skills
  • Must be able to obtain and maintain a security clearance

  • Vector production and/or cell therapy products experience
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)