PCR Core Laboratory Technical Manager

Job DescriptionJob Description

Title: PCR Core Laboratory Technical Manager

Location: On Site, Frederick, MD

Status: Full Time

Travel: Negligible

Salary Range: $115,000-$140,000

Position Summary:

USAMRIID, located at Fort Detrick, Maryland, works closely with other U.S. Army Medical Research and Development Command (USAMRDC) organizations, Department of Defense (DoD), the Interagency (including Interagency Laboratories), and private companies to accomplish its mission of protecting the Warfighter from biological threats and being prepared to investigate disease outbreaks or threats to public health. This includes conducting Research, Development, Testing, & Evaluation (RDTE) of medical countermeasure against biological threats and the safety, quality assurance, project management, and core support required for these research activities.

The Diagnostic Systems Division (DSD) provides reference diagnostic and disease assessment consultation within the medical community in support of DoD operational requirements. DSD supports analytical studies for advanced development and FDA clearance of diagnostic assays as well as pre-clinical studies of vaccine and therapeutic candidates. The division is functionally organized into four departments: Developmental Diagnostics, Applied Diagnostics, Operational Diagnostics, and Regulated Products.

The PCR Core Laboratory Technical Manager will oversee and coordinate the activities of a technical support team performing Research Use Only (RUO), GLP, and GLP-like work, with a focus on high-volume RT-PCR assays and extractions in BSL-2, BSL-3, and BSL-4 environments. The role involves designing and assisting in studies to transition diagnostic assays from research to production, ensuring compliance with regulatory standards, and maintaining laboratory safety and quality control. Additional responsibilities include preparing monthly and quarterly reports, training personnel, managing laboratory equipment, and maintaining certifications. The position requires a strong background in molecular biology, laboratory management, and regulatory compliance, with experience in handling large-scale diagnostic testing and transitioning assays for FDA approval. This position is contingent upon contract award.

Duties/Responsibilities:

• Coordinate and oversee activities of 2 to 4 assigned technical support personnel performing Research Use Only (RUO), GLP, and GLP-like work. Manage a workload of 10,000 to 20,000 RT-PCR assays and 1,500 to 4,000 extractions per year, within BSL-2, BSL-3, and BSL-4 environments.
• Maintain a safe workplace and ensure compliance with occupational health and safety rules and regulations.
• Design, assist, and provide feedback for studies related to transitioning diagnostic assays from research use to assay production or FDA pre-EUA approval. Includes inclusivity, exclusivity, limits of detection, limits of quantitation studies, and basic statistical analysis, with a workload of 4 to 5 validations/transitions per year.
• Prepare and submit GLP Data Reports to the TPOC by the last day of each month and GLP Workload Reports by the last day of each quarter.
• Ensure all experiments are performed and documented in accordance with applicable regulations, including GLP, FDA Animal Rule, CLIP, and COLA.
• Procure key reagents and quality control materials, ensuring the integrity of 4 lots of reagent per assay, totaling approximately 25 qualifications annually.
• Serve as technical lead and train at least 5 personnel in the use of equipment and performance of assays, including ad hoc training and competency evaluation.
• Implement and maintain over 20 PCR Core Lab SOPs in coordination with the Division Quality Manager.
• Review all study data within 4 business days of completion and approve data for release to ensure accuracy and compliance with quality control and assurance guidance.
• Independently operate and schedule maintenance and repairs of laboratory facilities and equipment, ensuring 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, maintaining certification for such testing.
• Maintain training and certification for the DSD GLP Validation Study Director role, overseeing GLP studies in the Diagnostic Systems Division.
• Present work at local or off-site scientific meetings 1-2 times per year.
• Travel CONUS/OCONUS as required in support of the diagnostic mission, training, and/or presentation of scientific research, including remote, resource-limited locations.

Minimum Requirements:

• Bachelors degree in relevant field required; masters degree strongly . Relevant certifications strongly considered
• 3+ years experience managing and overseeing technical support personnel, preferably in a laboratory or clinical setting.
• 5+ years Experience with RT-PCR assays and laboratory extractions, particularly in high-volume settings (10,000 to 20,000 assays and 1,500 to 4,000 extractions annually).
• Knowledge of working in BSL-2, BSL-3, and BSL-4 environments.
• Familiarity with GLP and FDA pre-EUA approval processes .
• Certification and experience in conducting environmental sample testing under ISO/IEC 17025 conditions strongly
• BPRP enrollment and ability to maintain compliance with all applicable regulations.

Work Environment:

• Laboratory environment

Physical Demands:

• May lift up to 25lbs

Benefits:

KIC offers a comprehensive benefits package to eligible full-time employees including: Medical, Dental, and Vision Insurance, 401k with Match, Life and ADD Coverage, Short and Long Term , Paid Time Off and Holidays, Education Assistance/Tuition Reimbursement, Employee Assistance Program, Employee Discount Program, and more!

Apply online at our website: https://kikiktagruk.applicantpool.com/

Disclaimer:

This is not to be an exclusive list of all responsibilities, duties, and skills required of the person in this job. KIC is an Equal Opportunity Employer. KIC considers all applicants for employment without regard to , , , , , , physical or mental , family responsibility, marital status, , political affiliation, veteran's status, , or any other legal protected status.

Pursuant to The Alaska Claims Settlement Act 43 U.S.C. Sec. 1601 et seq., and federal contractual requirements, Kikiktagruk Inupiat Corporation, may legally grant certain preference in employment opportunities to KIC Shareholders, and their Descendants.

Successful candidates must adhere to KIC's Drug and Alcohol policy/testing requirements and may be required to pass a background and/or Motor Vehicle Records check.

The salary range for this position is based on several factors, including relevant experience, education, skills, and current market conditions. We aim to provide a fair and equitable salary, that remains competitive within the industry.