Manufacturing/Cell Therapy Specialist II (req1915)

Posted: 9/20/2021
Location: Bethesda, MD
Employee Type: exempt full-time
Job ID: req1915

PROGRAM DESCRIPTION

Within Leidos Biomedical Research Inc. (operator of the Frederick National Laboratory for Cancer Research), the Clinical Research Directorate (CRD) provides clinical supervision of programs at the clinical end of the research spectrum. The quality assurance programs provide the required autonomy and transparency of Good Manufacturing Practice quality assurance operations. CRD also provides operational support for clinical research and supports clinical trials management, regulation, pharmacovigilance, and protocol development/protocol navigations. These support services include dedicated clinical research professionals who provide patient care to clinical trial participants at the National Institutes of Health (NIH) Clinical Center, and other research services that support the domestic and international clinical research initiatives of the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), and several other institutes within NIH. . CRD's support services are strategically aligned with its mission to provide comprehensive, dedicated support to assist NIH researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, protecting human subjects, and helping to advance scientific clinical research. CRD facilitates the conduct of NIH-sponsored clinical trials that investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, parasitic infections, heart, lung and blood disorders, and rare and neglected diseases. CRD's collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CRD's mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Research Directorate (CRD) provides support of innovative T-cell therapies and vector production for cancer treatment for the National Cancer Institute's (NCI's), Center for Cancer Research (CCR), Surgery Branch (SB).

KEY ROLES/RESPONSIBILITIES

  • Works as part of a small team to execute GMP runs in close collaboration with Process Development and Quality Assurance and Quality Control groups
  • Assists in the development of standard operating procedures, batch records, deviations, and change controls
  • Reviews manufacturing records and test data
  • Identifies potential bottlenecks in the upcoming development process and work with all 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
  • This position is located in Bethesda, Maryland

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

  • Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
  • In addition to educational requirements, a minimum of two (2) years of job-related experience
  • Cell culture processing experience
  • Excellent aseptic/sterile techniques
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • 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)
  • 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

JOB HAZARDS

  • This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations