Process Development Scientist I/II
Job ID: req2266
Employee Type: exempt full-time
Division: Clinical Research Program
Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA
The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.
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 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.
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
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 (additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency Level I - No experience required beyond education Level II - In addition to educational requirements, a minimum of two (2) years of relevant experience Experience in viral vector production or GMP biopharmaceutical production strategies Experience with handling and propagation of immortalized cell lines e.g., HEK293s. 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 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 Knowledge of production-related principles of biopharmaceutical development and production processes Knowledge of cGMPs as they relate to biopharmaceutical manufacturing Capable of ensuring quality control and fiscal planning Must be able to obtain and maintain a security clearance
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
This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations This position is subject to working with radioactive material and requires to become an approved radiation worker
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
As directed by Executive Order 14042: Ensuring Adequate COVID Safety Protocols for Federal Contractors, effective December 8, 2021, Frederick National Laboratory (FNL) will require employees of Leidos Biomedical Research (LBR) and all newly hired employees before their start date, in the United States, to be fully vaccinated or have a qualified exemption.