Breadcrumb

Quality Control Analyst II - Immunotherapy clinical trials, cell culture, GMP

Date Posted
Position is with
Lab/Branch/Program

Job Description

KEY ROLES/RESPONSIBILITIES:

  • Performs Quality Control (QC) testing of materials, intermediates, and final products manufactured for first-in-human immunotherapy clinical trials
  • Performs cell culture of human primary cells, ELISA, FACS, PCR and qPCR assays as required for lot release
  • Identifies potential bottlenecks and works with team members and senior management to resolve them
  • Performs required data analysis, compiles data, and prepares results for review
  • Interprets test results, compares to established specifications and control limits and makes recommendations on appropriateness of data for release
  • Provides updates at daily and weekly meetings
  • Assists in developing testing and analysis methods and procedures in accordance with established guidelines
  • Coordinates maintenance and calibration of equipment and instruments used in testing of clinical products
  • Monitors the GMP systems currently in place to ensure compliance with documented policies
  • Assists with investigations regarding out of specifications (OOS) results; addresses and manages deviations related to analytical procedures
  • Works collaboratively to develop, revise, and review SOPs, qualification/validation protocols and reports
  • Participates in internal assessments and audits
  • Plans own activities on a weekly basis in accordance with established schedules and in accordance with group objectives and priorities
  • Trains new employees as required on techniques and SOPs
  • Provides support with data documentation, technical writing, and document organization
  • Performs daily maintenance and laboratory tasks

Qualifications and Job Details

Degree Required
B.S./B.A. or equivalent
Job Location
Bethesda
Appointment Type
Contractor Position (Salary commensurate with experience)
Work Schedule
Full-time
Citizenship
US Citizenship not required - (ie, permanent resident, visa)

Required and Preferred Skills

Required Skills
  • Possession of a bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education)
  • In addition to educational requirements, a minimum of two (2) years progressively responsible quality control experience
  • Foreign degrees must be evaluated for U.S. equivalence
  • Working knowledge of current Good Manufacturing Practices (cGMP) and scientific principles
  • Ability to follow SOPs and comply with cGMP regulations
  • Develop analytical methods and generate SOPs
  • Perform a variety of analyses including computer-based instrumental analytical methods
  • Good technical writing skills
  • Must be able to obtain and maintain a clearance
Preferred Skills
  • General knowledge of Biosafety Level 2 (BL2)
  • Analytical equipment qualification
  • Demonstrated ability to interface with Manufacturing, Quality Assurance, Materials Management

About the NCI Center for Cancer Research

The Center for Cancer Research (CCR) is home to nearly 250 basic and clinical research groups located on two campuses just outside of Washington, D.C. CCR is part of the National Cancer Institute (NCI) and makes up the largest component of the research effort at the National Institutes of Health (NIH). Centrally supported by long-term funding and a culture of complete intellectual freedom, CCR scientists are able to pursue the most important and challenging problems in cancer research. We collaborate with academic and commercial partners and advocacy groups across the world in efforts to prevent, diagnose and treat cancer and HIV/AIDS. The CCR research portfolio covers the full spectrum of biological and biomedical research. Our work ranges from basic to translational and clinical, and our clinical trials are conducted in the NIH Clinical Center, the world’s largest hospital dedicated to clinical research that offers a robust infrastructure to support CCR’s patients on an estimated 250 open studies. The success of CCR is grounded in an exceptionally strong discovery research program that provides the foundation for the seamless translation of insights from bench to bedside. Read more about CCR, the benefits of working at CCR and hear from our staff on their CCR experiences.

Bethesda

Bethesda is one of the most highly educated communities in the United States and has a nationally renowned school system. The city is a thriving suburban center close to Washington, D.C., and home to many restaurants, retailers and a flourishing arts and entertainment district.

How to Apply
Submit:
  • CV/Resume
  • Three References
  • Cover Letter
Additional Application Information

How to Apply: https://leidosbiomed.csod.com/ats/careersite/jobdetails.aspx?site=4&c=leidosbiomed&id=572. Please reference job id req2573 for all inquiries. Hiring for this position will be through Leidos Biomedical Research Inc., a wholly owned subsidiary of Leidos, Inc.  Leidos Biomedical is the operations and technical support contractor for the Frederick National Laboratory for Cancer Research, a federal national laboratory.

Contact Information
Contact Name
Lauri Rimorin
E-mail Address
Lauri.Rimorin@nih.gov
DHHS, NIH and NCI are equal opportunity employers. The NCI and CCR are deeply committed to diversity of thought, equity and inclusion and encourage applications from qualified women, underrepresented minorities and individuals with disabilities.