QC Manager III in Frederick, MD

Description

QC Manager III

Job ID: req1610
Employee Type: exempt full-time
Facility: Frederick: ATRF
Location: 8560 Progress Dr, Frederick, MD 21701 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.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public's interest.  

 Position Overview:

PROGRAM DESCRIPTION         

 The Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the National Cancer Institute (NCI) and other government agencies through the development of novel agents for first-in-man clinical studies.

KEY ROLES/RESPONSIBILITIES

• Oversee the cell therapy bioanalytical testing lab to support in-process, release, and stability testing of drug substances and products
• Analytical support for the NCI CAR-T cell therapy program
• Establish specifications and control limits for in-process materials and final drug substance/product
• Ensure the appropriate GMP guidelines are met, implemented and maintained
• Be responsible for the analysis of assay performance through trend analysis, stability reports, and investigating analytical and bioassay method technical issues
• Review data to compliance with established specifications
• Issue summary reports of testing, certificate of analysis, and other data summary reports
• Facilitate the incoming transfer of new assays
• Facilitate the qualification execution of new or updated assays
• Assist in the preparation of reports and data packages for interactions with regulatory agencies

 BASIC QUALIFICATIONS

• Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in biomedical research/biotechnology/biopharmaceutical or related field (experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
• In addition to education requirements, a minimum of eight (8) years of hands-on laboratory experience in biomedical research/biotechnology/biopharmaceutical or related field
• Understanding of Current Good Manufacturing Processes (cGMP), Quality Control (QC), Standard Operating Procedure (SOP), CAR-T cell therapeutics, Antibody (mAb), Drug Product (DS), Drug Substance (DS), Active Pharmaceutical Ingredient (API), and validation (IQ/OQ/PQ)
• Extensive Biotechnology field knowledge in analytical, biochemical, and immunological testing
• Ability to implement a rigorous testing program with appropriate operating procedures, supervisory oversight, and cGMP compliance
• Experience in data evaluation, trending and troubleshooting
• Strong proficiency with investigational skills for root cause analysis; ability to lead technical investigations
• Knowledge of the USP, ICH, and FDA guidelines related to product testing
• Proficiency with assay methodologies including ligand-binding assays (e.g. ELISA, Western blotting), gel electrophoresis, PCR, spectrophotometry, bioassays, Western Blots and liquid chromatography
• Experience with DNA and protein technologies
• Excellent technical writing skills

PREFERRED QUALIFICATIONS

• Master's degree
• Experience in CAR T cell therapy desirable
• Experience with and/or knowledge of methods qualification/validation
• 5 years in a lead/supervisory role in a GMP environment
• Experience with cell culture, viral vectors, virus like particles (VLP), and recombinant protein technology platforms
• Proficiency with Microsoft Office, data analysis software, and other lab related applications
• Strong written and verbal communication skills
• Experience with analytical method development, qualification/validation

JOB HAZARDS

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
• This position is subject to the environmental conditions such as working outdoors, high humidity areas indoors, dampness and chilling, dry atmospheric conditions, etc. as part of the job

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

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