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Manufacturing Associate I - Cell production, sample tracking

Date Posted
Position is with
Lab/Branch/Program

Job Description

KEY ROLES/RESPONSIBILITIES:

  • Assists with preparation of technical reports, abstracts, presentations, and program correspondence concerning assigned projects through research and analysis of information relevant to government policy, regulations and other relevant data and monitor all assigned programs for compliance
  • Assists with development and implementation of procedures/programs to ensure effective and efficient business and operational processes
  • Helps to identify potential bottlenecks in the upcoming development process and works with all team members and senior management to resolve them
  • Assists with coordination of logistics, including purchasing and shipping of miscellaneous equipment, lab and office supplies to ensure compliance with appropriate government regulations
  • Maintains workflow and follows timelines to ensure production operations are on schedule and adequate raw materials and supplies are available
  • Assists with technical audits of outsourced contractors in conjunction with Quality Assurance and or Quality Control
  • Tracks EM samples (testing, results, actions)
  • Follows PM schedule and reporting

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 in a field related to biomedical research/scientific discipline or four (4) years relevant experience in lieu of degree
  • Foreign degrees must be evaluated for U.S. equivalency
  • No experience is required with a Bachelor’s degree (relevant experience may be substituted for the degree)
  • Possess knowledge of production-related principles of biopharmaceutical development and production processes
  • Working knowledge of cGMPs as they relate to biopharmaceutical manufacturing
  • Use of aseptic/sterile techniques
  • Self-motivated and willing to accept/learn temporary responsibilities outside of the 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
  • Knowledge of handling and propagation of human primary cells, including T cells
  • Strict adherence to SOPs and cGMP regulations, including excellent documentation skills
  • Proficiency in Microsoft Office® inclusive of Word, Excel, Access, and PowerPoint
  • Familiarity with interactive databases quality assurance, auditing, metrics analysis, cancer
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)

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 req2559 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.