Cell Therapy Manufacturing Specialist

Location
Bethesda, Maryland, United States
Posted
Oct 23, 2018
Ref
6
Hotbed
BioCapital
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).

KEY ROLES/RESPONSIBILITIES
  • 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

BASIC QUALIFICATIONS
  • 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

PREFERRED QUALIFICATIONS
  • 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)