QC Microbiology Analyst II

Job ID: req2522
Employee Type: exempt full-time
Division: Vaccine Clinical Materials Program
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 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.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION

The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its' mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.

KEY ROLES/RESPONSIBILITIES

Reporting to the QC Microbiology Associate Director, the QC Microbiology Analyst:

• Evaluates and implements protocols and methods to inspect and test in-process raw materials and finished products and ensure that they are in compliance with internal and external safety, quality and regulatory standards requirements for distribution.
• May assure compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma)
• Performs routine microbial analysis of water, in-process and product samples
• Performs required data analysis, compiles data and prepares results for review
• Conducts enumeration of environmental samples, performs bioburden analysis, and media and organism qualification
• Participates in internal assessments and audits
• Plans own activities on a weekly basis in accordance with established schedules and in accordance with group objectives and priorities
• Interprets test results, compare to established specifications and control limits
• Performs microbial analysis and wet chemistry testing
• Will be responsible for data documentation and technical writing
• Will be responsible for daily laboratory maintenance tasks
• May be required to work 2nd shift or early mornings as needed to support manufacturing activities

THIS POSITION MAY ALLOW FOR FLEXIBILITY FOR SOME TELEWORK.

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in biology, microbiology, chemistry, or similar scientific discipline (Qualifying four (4) years equivalent, directly relevant, experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, a minimum of two (2) years of related job-related experience
• Working knowledge of current Good Manufacturing Practices (cGMP) and scientific principles
• Ability to generate and follow standard operating procedure (SOPs), and comply with cGMP regulations
• Working knowledge of a laboratory environment and equipment used for pharmaceutical analysis
• Experience and ability to execute microbiology assay methodologies including enumeration, bioburden testing, media and organism qualification and the ability to subculture
• Good technical writing skills
• Ex perience working in a biotech or pharmaceutical testing environment
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• General knowledge of Biosafety Level 2 (BL2)
• Analytical instrument qualification
• Use of electronic systems E.g., MODA, LIMS
• Experience and knowledge of traditional and rapid microbial methods
• E xperience with microbial identification using a genetic analyzer
• Experience generating environmental monitoring trend reports
• Experience in product sterility testing

JOB HAZARDS

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations.

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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