high containment facility Fort Detrick, MD.
participate in deployment rotations to international and domestic sites.
Assist with Ebola disease survivor surveillance and research activities
Outbreak Response Scientist
Alaka`ina Foundation Family of Companies
Frederick, MD 21702
Employer actively reviewed job 27 days ago
$65,137 – $81,000 a year
Number of hires for this role
Research Experience: 3 years (Preferred)
Full Job Description
Laulima Government Solutions, LLC is looking for a qualified Outbreak Response Scientist to provide leadership support services for the National Institute of Allergies and Infectious Disease (NIAID) in a high containment facility in Fort Detrick, MD.
Description of Responsibilities:
- Support activities for laboratory preparedness and response to outbreaks of high consequence viral pathogens in field settings.
- Support research with refined animal models for biodefense agents and facilitate testing of human samples associated with naturally occurring outbreaks in the high containment environment.
- Potentially participate in deployment rotations to international and domestic sites.
- Assist with Ebola virus disease survivor surveillance and research activities in Africa.
- Comply with the NIH Division of Occupational Health and Safety requirement for satisfactory completion of the Biosurety program and Select Agent program.
- Play a role in ensuring that the Biosurety program promotes a security conscious culture.
- Comply with the physical security, protection of the division’s property, protection of information, cyber security, agent protection, control and accountability, safe disposal and waste handling, and personal security guidelines set forth by the division’s Biosurety program.
- Minimum of a full 4-year course of study from an accredited college or university leading to a Bachelor of Science or higher degree.
- Ability to work in BSL-4 setting
Required Skills and Experience:
- 3-5 years’ related experience
- Must have prior laboratory experience, including running various assays (immunologic, virologic, molecular)
- Clinical experience in biochemistry or hematology.
- Ability to obtain/maintain DoJ Security Risk Assessment (SRA) approval.
- Must be willing to be immunized with licensed and FDA approved Investigational New Drugs (IND) recommended for persons at risk to occupational exposure of biological agents
- Must be willing to participate in periodic drug screening.
- Must have the ability to obtain/maintain certification in Chemical Personnel Reliability Program and/or Biological Personnel Reliability Program.
- Must have the ability to obtain/maintain CDC Select Agent Program approval.
- Prior experience working in BSL-2 facilities, willingness to work BSL-3, and BSL-4 conditions. Able to wear respiratory protection.
- Must be willing to travel once called upon for a month at a time on average.
Desired Skills and Experience:
- Experience working effectively and respectfully with diverse groups in international settings.
- Familiarity with the conduct of clinical laboratory diagnostics, including molecular, immunologic, and virologic testing.
- Experience with viral Select Agents is highly desired.
- Good Clinical Laboratory Practice (GCLP) experience is preferred.
- Proficiency in Word, Excel, and PowerPoint.
- Basic understanding of laboratory information management systems (LIMS).
- Demonstrate interpersonal, oral and written communication, and organizational skills.
- Demonstrate ability to work independently, design experiments, and analyze data.
- French language skills.
- Must be a US citizen or permanent resident.
- Must be able to meet the requirements for Tier 3 level investigation.
Laulima Government Solutions, LLC is a fast-growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 10 paid holidays. Laulima Government Solutions, LLC is proud to be an equal opportunity employer.
Job Type: Full-time
Pay: $65,137.00 – $81,000.00 per year
- 401(k) matching
- Dental insurance
- Disability insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Professional development assistance
- Referral program
- Vision insurance
- 8 hour shift
- Monday to Friday
- Bachelor’s (Preferred)
- Research Experience: 3 years (Preferred)
Willingness To Travel:
- 25% (Preferred)
- One location
- Remote interview process
Manufacturing/Cell Therapy Associate II
Bethesda, MD 20892
Full Job Description
Manufacturing/Cell Therapy Associate II
Job ID: req1731
Employee Type: exempt full-time
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.
Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.
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.
- Establishes, implements and maintains standardized processes and assess performance to make recommendations for improvement
- 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 monitors 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 leader/mentor to administrative staff
- Develops and implements procedures/programs to ensure effective and efficient business and operational processes
- Identifies potential bottlenecks in the upcoming development process and works with all team members and senior management to resolve them
- Analyzes and tracks initiatives and contracts
- Coordinates and reviews daily operations and logistics, including purchasing and shipping of miscellaneous equipment, lab 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 annually
- Manages the Environmental Monitoring Program and the environmental monitoring sample collection
- Schedules, tracks, and collects Environmental Monitoring samples
- Manages the Materials Management Program
- Manages equipment and facility preventative maintenance
- Establishes/manages Preventive Monitoring contract, schedule and reports
- Manages facility cleaning programs, change control, and ensures contractors are following SOPs
- Manages/schedules manufacturing change overs in the Cell Processing Facility
- Trains and supervises new employees and junior employees on existing protocols and SOPs
- Reviews routine records, test data, and patient binders
- Participates in process investigation and deviation
- The position is located in Bethesda, Maryland
- 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
- A minimum of two (2) years of job-related experience (may be pharmaceutical, clinical, etc.)
- 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
- Experience with aseptic/sterile techniques
- Must be able to obtain and maintain a security clearance
- Experience with handling and propagation of human primary cells, preferably T cells
- Experience in cellular therapy manufacturing
- Strict adherence to SOPs and cGMP regulations, including excellent documentation skills
- Proficiency in Microsoft Office® inclusive of Word, Excel, Access and PowerPoint
- Principles of timelines within Microsoft® Project
- Familiarity with interactive databases quality assurance, auditing, metrics analysis, cancer
- Cell therapy products experience
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
- Ability to communicate with technical and scientific staff
- 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
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
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