Manufacturing Associate I- Cell Therapy

Location
Bethesda, MD, USA
Posted
Aug 15, 2019
Ref
req667
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD's ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRPD's collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program's mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Monitoring Research Program Directorate (CMRPD) provides implementation and oversight of multiple NCI/CCR cell processing facilities within the National Cancer Institute's (NCI's), Center for Cancer Research (CCR), Surgery Branch Cell Production Facility.

KEY ROLES/RESPONSIBILITIES-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL
  • 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
  • Schedule, track and collect EM samples
  • Monitor and document daily environmental conditions
  • Release cleanroom
  • Perform monthly equipment cleaning
  • Receive, distribute and ship out products and responsible for maintaining product inventory
  • Initial equipment validation and IQ, OQ and PQ
  • Follows PM schedule and reporting
  • The position is located in Bethesda, Maryland

BASIC QUALIFICATIONS
  • 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)
  • Knowledge of or experience with aseptic/sterile techniques
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS
  • Knowledge of handling and propagation of human primary cells, preferably 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)
  • Possess knowledge of production-related principles of protocol generation and adherence, strict laboratory documentation, and good laboratory documentation, and good laboratory practices (GLPs)
  • Working knowledge of cGMPs as they relate to biopharmaceutical manufacturing
  • Ability to communicate with technical and scientific staff

JOB HAZARDS OR REQUIREMENTS
  • Candidate will be working with or have the potential for exposure to infectious material(s) or Other Potentially Infectious Materials (OPIM), requiring medical clearance and immunization in accordance with protocol requirements