PCR Core Laboratory Technical Manager

The Alaka`ina Foundation Family of Companies (FOCs) has a Potential need for a PCR Core Laboratory Technical Manager to support our government customer located in Frederick, MD at Fort Detrick.

DESCRIPTION OF RESPONSIBILITIES:

• Coordinate and oversee activities of the 2 to 4 assigned, technical support personnel performing Research Use Only (RUO), GLP and GLP-like work. Experiments will be performed in BSL-2, BSL-3 and BSL-4 environments.
• Maintain a safe workplace; comply with occupational health and safety rules and regulations
• Design, assist and provide feedback for studies and activities associated with transitioning diagnostic assays from research use to assay production or FDA pre-EUA approval; to include but not limited to, inclusivity, exclusivity, limits of detection, limits of quantitation studies and basic statistical analysis.
• Prepare and provide a GLP Data Report each month and a GLP Workload Report each quarter.
• Ensure all experiments are performed and documented IAW applicable regulations dictated by study protocol (i.e. GLP, FDA Animal Rule, CLIP, COLA).
• Procure key reagents, quality control materials; ensure integrity of reagent and quality control materials.
• Serve as technical lead training at least 5 personnel in the use of equipment and performance of assays. May include ad hoc training and competency evaluation of other personnel
• Implement and maintain over 20 PCR Core Lab SOPs in coordination with Division Quality Manager.
• Review all study data within 4 business days of completion and approve data for release to ensure correctness and compliance with quality control and quality assurance guidance.
• Independently operate and schedule maintenance and repairs of laboratory facilities and equipment; ensure maintenance and repairs are performed IAW requirements resulting in no more than 5 days of downtime
• Perform experiments, data collection and analysis in support of the Special Pathogens Laboratory and other Diagnostic Systems Division labs.
• Conduct environmental sample testing under ISO/IEC 17025 conditions within the Special Pathogens Laboratory. Maintain certification to conduct testing under ISO/IEC 17025.
• Maintain training and certification for the DSD GLP Validation Study Director role. The Study Director oversees GLP studies conducted in the Diagnostic Systems Division.
• Present work at local or off site scientific meeting 1-2 times per year.
• CONUS/OCONUS travel may be required in support of the diagnostic mission, training, and/or presentation of scientific research. Travel locations may include remote, resource-limited locations.
  
  

REQUIRED DEGREE/EDUCATION/CERTIFICATION:

• Masters level degree in biological sciences with four years of relevant experience or baccalaureate level degree in biological sciences with eight years of relevant experience.
  
  

REQUIRED SKILLS AND EXPERIENCE:

• Must have professional experience in virology, molecular biology, immunology, or public health.
• Must have four years of specialized training in research.
• Ability to obtain/maintain DOJ Security Risk Assessment approval.
• Must be willing to be immunized with licensed and FDA approved Investigational New Drugs recommended for persons at risk for occupational exposure to biological agents.
• Must be willing to participate in periodic drug screening.
• Able to wear respiratory protection.
• Demonstrate interpersonal, oral and written communication, and organizational skills.
  
  

REQUIRED CITIZENSHIP AND CLEARANCE:

• U.S. Citizen
• Must pass NACI background check.
• Must be willing to work in a BSL 3/4 laboratory.
• Must be eligible to enroll in the BPRP and CS-PRP programs.
  
  

The Alaka`ina Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries. Eligible full-time employees enjoy a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.

We are an Equal Opportunity/Affirmative Action Employer. We are proud to state that we do not discriminate in employment decisions on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, 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.

The Alaka`ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke`aki Technologies, Laulima Government Solutions, Kūpono Government Services, and Kāpili Services, Po`okela Solutions, Kīkaha Solutions, LLC, and Pololei Solutions, LLC. Alaka`ina Foundation activities principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.

For additional information, please visit www.alakainafoundation.com

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