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Manufacturing Associate II - GMP, cell line, T cell, vector production

Date Posted
Position is with
Lab/Branch/Program

Job Description

The Clinical Monitoring Research Program Directorate provides support of innovative T-cell therapies and vector production for cancer treatment facilities within the NCI’s CCR, Surgery Branch (SB), Vector Production Facility.
KEY ROLES/RESPONSIBILITIES:

  • Works as part of a small team to execute GMP runs to produce clinical grade vector products in close collaboration with Process Development and Quality Assurance and Quality Control units
  • Assists in the development of standard operating procedures, batch records, deviations, and change controls
  • Reviews manufacturing records and test data
  • Identifies potential bottlenecks and works with team members and senior management to resolve them
  • Participates in investigations regarding out of specifications/trend (OOS/OOT) results; addresses and manages deviations related to manufacturing procedures
  • Maintains reagent inventories, order supplies, cleans laboratory areas, hoods, incubators, and group equipment, and assures equipment and facility functionality and preventative maintenance/qualification/certification for use
  • Manages facility cleaning programs, change controls, and ensures contractors are following SOPs
  • Manages/schedules manufacturing change overs in the Vector Production Facility
  • Manages the Environmental Monitoring (EM) Program and the EM sample collection for the facility
  • Tracks EM samples (testing, results, actions)
  • Performs required data analysis, compiles data, and prepares results for review

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/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
  • Excellent aseptic/sterile techniques
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description
  • Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
  • Must be able to obtain and maintain a security clearance
Preferred Skills
  • Experience with handling and propagation of immortalized cell lines e.g., HEK293s
  • Experience with handling and propagation of human primary cells, including T cells
  • Strict adherence to SOPs and cGMP regulations, including excellent documentation skills
  • Excellent skill in Microsoft word, Excel, and data analysis
  • Vector production and/or cell therapy products experience
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
  • Demonstrated ability to work both independently and as a member of a team
  • Demonstrated ability to train and supervise others

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

To apply, click here https://leidosbiomed.csod.com/ats/careersite/jobdetails.aspx?site=4&c=leidosbiomed&id=572. Please reference job id req2766 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.