Laulima Government Solutions is the second company established as the Family of Companies (FOCs) under the Alaka`ina Foundation, a Native Hawaiian Organization (NHO). The Foundation Family of Companies (FOCs) also includes Ke`aki Technologies and Kupono Government Services. Alaka`ina is the parent 501(c)3 of the Alaka`ina Foundation whose activities principally benefit the youth of Hawaii. A portion of the profits generated by the FOCs helps support Alaka`ina charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.
Laulima has an exciting opportunity for a Biodefense Regulated Laboratory Analyst in Frederick, MD supporting the military medical community.
The Biodefense Regulated Laboratory Analyst will conduct studies in accordance with the FDA GLP 21 CFR Part 58 and support a variety of laboratory-based activities associated with FDA regulatory compliance, analytical method optimization and validation.
Develop standard operating procedures (SOPs) study-specific procedures (SSP), and other relevant study documentation to ensure compliance with Good Laboratory Practices (GLP) regulation.
Review protocols, study plans, and associated documentation to support research and development projects under GLP for products regulated by the Food and Drug Administration (FDA).
Organizes and tabulates laboratory records and resulting data to ensure complete study files.
Analyzes data and prepares reports for submission to FDA.
Assist investigators to ensure that PI written reports are in compliance with appropriate standards, e.g., 21 CFR regulations.
Assist principal investigators in developing documentation packages from laboratory studies that can support investigational and new drug applications (IND/NDA).
Work effort contributes to an array of FDA regulatory documents e.g., Master File, IND/IDE, NDA/PMA, 510 (k) notification.
Imparts and shares knowledge through in-lab training and side-by-side work for the transmittal of regulatory concepts, practices, and procedures.
Perform laboratory quality management activities for supported customers to the required quality standard, e.g., GLP.
Support analytical method validation studies to support use in FDA-regulated studies.
Support medical or advanced animal research, including Animal Rule Studies.
Support the SIP Program by assisting GLP compliant studies for potency testing of clinical research materials.
Support product release testing (potency, identity, stability) for cGMP manufactured materials.
Ensure integrity and quality of study data to include tracking and storage of investigational materials.
Execute regulated studies as Principal Analyst, as required.
Utilize techniques for protein quantification, antibody assays, tissue culture, neutralization assays, plaque assay, and other microbiological/biochemical methods, as needed.
Assist in development of new immunological assays, as needed.
Assist with animal manipulations i.e. handling, bleeding, minute volume measurements, assisting in necropsy, and isolation of tissues.
Tabulate, analyze and interpret data.
Required Education / Experience:
Bachelor's degree in Biology, Microbiology, Chemistry or other scientific field of study and a minimum of 5 years of related experience, OR Master's degree in Biology, Microbiology, Chemistry or other scientific field of study and a minimum of 1 year of related experience.
Other Required Experience:
Will be expected to work in biocontainment environments (i.e., BSL-2, -3, and BSL-4, as needed).
Shall be knowledgeable in microbiology, laboratory sciences, and regulated laboratory requirements.
Must be able to execute regulated studies as Principal Analyst, as required.
Must be able to utilize techniques for protein quantification, antibody assays, and tissue culture assays.
Must be able to assist with animal manipulations i.e. handling, bleeding, minute volume measurements, assisting in necropsy, and isolation of tissues.
Must be able to tabulate, analyze and interpret data.
Must be able to maintain a safe workplace and comply with occupational health and safety rules and regulations.
Will be required to attend safety training(s) relative to his/her position and report any infractions of safety procedures to the TOCOR immediately.
Must complete mandatory Federal, DoD, Army, and USAMRIID trainings as required.
Enrollment in the Biological Personnel Reliability Program (BPRP) for handling select agents - he or she must maintain enrollment. Applicants must meet eligibility requirements as regulated by Army Regulation 50-1 (AR 50-1)-
A favorable Single Scope Background Investigation (SSBI) is required.
Laulima Government Solutions 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 is proud to be an equal opportunity employer.
For additional information on Laulima Government Solutions, please visit.
We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not discriminate in employment decisions on the basis of race, color, religion, sex, national origin or disability status. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees.