Job Details - Quality Control Scientist - 38486349 | Frederick National Laboratory Talent Network
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Quality Control Scientist II in Frederick, MD

Location: Frederick, MD
Career Level: Entry Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Quality Control Scientist II

Job ID: req1727
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 Scientist for biopharmaceutical testing
  • Analytical support for the NCI CAR-T cell therapy program
  • Labwork, assay development, data analysis and writing technical reports
  • Establish specifications and control limits for in-process materials and final drug substance/product
  • Responsible for the analysis of assay performance through trend analysis, stability reports, and investigating analytical and bioassay method technical issues
  • Issue summary reports of testing, certificate of analysis, and other data summary reports
  • Review QC test reports and data for compliance with established protocols and specifications
  • 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
  • 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 PhD degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) or eight (8) years of related experience.  Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the education requirement, a minimum of two (2) years of progressively responsible experience 
  • Experience with DNA and protein technologies
  • 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 flow cytometry, PCR, spectrophotometry and bioassays
  • 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)
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Four (4) years of hands-on laboratory experience in biomedical research/biotechnology/biopharmaceutical
  • 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
  • Four (4) years post-doctoral experience in a lead/supervisory role in a GMP environment
  • Experience with cell culture, viral vectors, virus like particles (VLP), and recombinant protein technology platforms
  • Experience with analytical method development, qualification/validation
  • Experience with next generation sequencing

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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