QC Analyst IV in Frederick, MD

Description

QC Analyst IV

Job ID: req1611
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

• cGMP Quality Control analyst for biopharmaceutical testing
• Analytical support for the NCI CAR-T cell therapy program
• Data analysis and writing technical reports
• Develop, revise, and review SOPs, protocols, and technical reports
• Support of QC functions (SOPs, logbooks, deviations, audits, investigations, CAPA, training, change control, and technical reports)
• Performing instrument and assay validation or qualification procedures

BASIC QUALIFICATIONS

• Possession of a Bachelor 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
• Extensive biotechnology field knowledge in analytical, biochemical and immunological testing
• Ability to implement a rigorous testing program with appropriate operating procedures and cGMP compliance
• Experience in data evaluation, trending and troubleshooting
• Excellent technical writing skills
• Proficiency with analytical methods including ligand-binding assays, FACS, PCR, spectrophotometry, bioassays, and liquid chromatography
• Prior experience with instrument and process validation or qualification procedures
• Knowledge of the USP, ICH and FDA guidelines related to product testing
• 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)
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• Knowledge of GMPs, SOPs, good documentation practices and quality control operations
• Experience with DNA, immunological and cell-based technology platforms
• Proficiency with Microsoft Office, data analysis software, and other lab related applications
• Strong written and verbal communication skills
• Experience with 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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