Biodefense Regulated Laboratory Investigator

Job Description:

Akimeka Technologies, LLC, headquartered in Honolulu, Hawaii, is a Native Hawaiian Organization (NHO)-Owned 8(a), Small Disadvantaged Business.  It is majority owned by the Alaka`ina Foundation, a Native Hawaiian nonprofit corporation whose activities principally benefit Native Hawaiians.  

The primary focus of Akimeka Technologies is providing a wide range of Information Technology, Program Management, and Telecommunications products, services, and solutions to Department of Defense clients in Hawaii and abroad.  

Akimeka Technologies LLC, has an exciting opportunity for a Biodefense Regulated Laboratory Investigator.  The position will be located at USAMRIID, Ft. Detrick, Frederick, Maryland.

Duties:

Executes studies as Study Director to ensure GLP compliance. 

Perform or manage a variety of laboratory-based activities associated with FDA regulatory compliance, analytical method optimization & validation.

Develops protocols, study plans, standard operating procedures (SOPs) study-specific procedures (SSP), etc. 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 ready for submission to FDA. 

Collaborates with investigators to ensure that PI written reports are in compliance with appropriate standards, e.g., 21 CFR regulations.

Coordinates support to 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.

Impart and shares knowledge through in-lab training and side-by-side work for the transmittal of regulatory concepts, practices, and procedures. 

Performs or supports analytical method validation studies to support use in FDA-regulated studies. 

Supports medical or advanced animal research, including Animal Rule Studies, by performing GLP compliant studies of investigational specimens from these studies. 

Supports SIP Program by performing GLP compliant studies for potency testing of clinical research materials. 

Supports product release testing (potency, identity, stability) for cGMP manufactured materials. 

Ensures that integrity of the data and the quality of all studies meets acceptable quality levels, to include tracking and storage of investigational materials.

Education:

Ph.D in the biomedical sciences and at least 10 years experience in biomedical research and development or equivalent experience. 

Required Skills:

Shall be knowledgeable in pathogenic microbiology, molecular biology and FDA regulatory affairs.

Desired Skills:  N/A

Job Type: Full Time Employee

Position Location/Timeframe: USAMRIID, Ft. Detrick, Frederick, Maryland.

Clearance required:

Applicants may be subject to a government security investigation and must meet eligibility requirements for access to classified information.

Akimeka Technologies LLC is a growing IT provider who recognizes the value of its employees.  Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid vacation and sick time; and 10 paid holidays.  Akimeka is proud to be an equal opportunity employer.  

For additional information on Akimeka Technologies, LLC, please visit www.akimekatech.com .

Akimeka Technologies, LLC, is an Equal Opportunity Employer