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Developmental Scientist- Cellular Therapy/Vector Production (NCI)

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Job Number:
640839
Job Category:
Scientist / Research & Development
Location:
BETHESDA, MD US
Schedule:
Full-time
Travel:
None
Shift:
Day Job
Potential for Teleworking:
Yes
Clearance Level Must Currently Possess:
None
Clearance Level Must Be Able to Obtain:
Public Trust
Description:
PROGRAM DESCRIPTION

Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) 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 Institute of 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, CMRP’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. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health 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, CMRP services include comprehensive clinical trials, 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.  CMRP’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.


JOB DESCRIPTION 

The Clinical Monitoring Research Program (CMRP) provides quality assurance and regulatory compliance support to the National Cancer Institute’s (NCI’s), Center for Cancer Research (CCR), Surgery Branch Cell Production Facility, Department of Transfusion Medicine, Quality Assurance and Regulatory Affairs Office (DTM-QA).

 

The Developmental Scientist will provide support and advisement to the manufacturing facilities for the cellular therapy program(s) at the NIH Clinical Center.  In cellular therapy protocols, cells are removed from patients via apheresis.  These cells are usually T Lymphocytes but may be B cells or macrophages.  The cells are cultured and grown up to large volumes under Phase I cGMP conditions.  They may be transfected (using Lenti-viral or retroviral vectors produced in the associated Vector Laboratory) with receptors that target a specific tumor antigen.   The cells are then returned to the patient of origin.

 

Key Roles/Responsibilities:

  • Establishes, implements and maintains standardized processes and assesses performance to make recommendations for improvement
  • Provides support and guidance to the cellular therapy or vector production facilities at the NIH Clinical Center engaged in the manufacture of patient specific therapies
  • Manufactures cellular therapy products for human use
  • Develops and manufactures lentiviral and/or retroviral vectors
  • Prepares 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
  • Provides project management support with planning and development of project schedules and deliverables, tracking project milestones, managing timelines, preparing status reports and monitoring progress ensuring adherence to deadlines
  • Facilitates communication through all levels of staff by functioning as a liaison between internal departments, senior management, and the customer
  • Serves as a leader/mentor to administrative staff and prepares employee performance evaluations
  • Develops and implements procedures/programs to ensure effective and efficient business and operational processes
  • Identifies potential bottlenecks in upcoming development processes and works with team members and senior management for resolution
  • Analyzes and tracks initiatives and contracts
  • Coordinates and reviews daily operations and logistics, including purchasing and shipping of miscellaneous equipment, laboratory and office supplies to ensure compliance with appropriate government regulations
  • Coordinates the administrative, fiscal, contractual, and quality aspects of all projects
  • Ensures that internal budgets, schedules and performance requirements are met
  • Monitors workflow and timelines to ensure production operations are on schedule and adequate raw materials and supplies are available
  • Ensures all activities are in compliance with applicable federal regulations and guidelines and proper testing/validation activities have been scheduled and conducted
  • Regularly interacts with senior or executive management both internally and externally, on matters concerning several functional areas such as operations, quality control and quality assurance
  • Participates in planning facility or operations modifications, upgrades and renovations
  • Performs technical audits of outsourced contractors in conjunction with Quality Assurance and or Quality Control
  • Assists in the evaluation and selection of staff, planning and coordination of training, assigning of tasks and scheduling workloads and evaluating overall performance
  • This position is located in Bethesda, Maryland


Qualifications:
BASIC QUALIFICATIONS

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

  • Possession of a Doctoral degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/scientific discipline
  • Foreign degrees must be evaluated for U.S. equivalency
  • In addition to education requirement, a minimum of five (5) years of progressively responsible job-related experience.  This includes working in a laboratory developing lentiviral and/or retroviral vectors for gene therapy and hands-on experience with development/manufacturing of cellular therapies for human use
  • Experience in cellular therapy manufacture or vector production
  • Must be detail-oriented and possess strong organizational, analytical and problem-solving skills with the ability to prioritize multiple tasks/projects of highly complex scope
  • Demonstrate strong communication skills, analytical ability and solid interpersonal skills
  • Ability to perform job requirements independently and in team environments and must have ability to interface with all levels of management making decisions regarding complex issues
  • Ability to develop and maintain manufacturing operations under cGMP compliance
  • Possess knowledge of production-related principles of biopharmaceutical development and production processes
  • Working knowledge of cGMPs as they relate to biopharmaceutical manufacturing
  • Capable of ensuring quality control and fiscal planning
  • Ability to work in high-pressure, time-sensitive situations; ability to multi-task and appropriately handle competing priorities
  • Must be able to obtain and maintain a clearance
PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Proficiency in Microsoft Office® inclusive of Word, Excel, Access and PowerPoint
  • Principles of timelines within Microsoft® Project
  • Familiarity with interactive databases quality assurance, quality systems, auditing, metrics analysis, cancer


Leidos Overview:
Leidos is a global science and technology solutions leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer.
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