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Quality Control Scientist II (req1974)

Frederick National Laboratory
Hood College, MD
Closing date
Nov 29, 2021

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Science, Pharmaceutical, Quality Assurance
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The Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the Frederick National Laboratory for Cancer Research (FNLCR) and other government agencies through the development of novel agents for first-in-man clinical studies.


* Independently carry out basic mass spectrometry operation (sample preparation, enzymatic digestion, mobile phase preparation/characterization, basic instrument troubleshooting and problem solving)
* Designs, develops, and applies methods for the characterization of proteins for human therapeutic use. Analyze and interpret data, and report results
* Perform targeted protein identification, protein characterization and quantitative proteomics experiments from sample preparation, LC MS/MS data collection and data analysis
* Design and develop LC-MS methodologies for viral vector-based therapies including AAV gene therapy product characterization and optimization of AAV platforms
* Develop LC-MS based workflows for host-cell protein identification
* Responsible for timely evaluation of QC samples and interpretation of data
* Maintain accurate records of data. Keep accurate, clear, and updated notebooks and records with timely record all experimental findings
* Communicate results with summary sheets and present scientific results to the project teams
* Perform other MS-based and non-MS-based experiments as needed to support analytical, CMC, and bioanalytical needs
* Author and review SOPs and technical reports
* Other related duties as assigned


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

* Possession of a PhD degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in Analytical Chemistry, Biochemistry, Chemical/Biochemical Engineering, or related field 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 specialization in Mass Spectroscopy
* Prior experience in GMP or Pharmaceutical industry
* Must have hands on experience with liquid chromatography and protein mass spectrometry with experience in analytical development for biotherapeutic candidates
* Experience with protein characterization by intact protein analysis, peptide mapping and glycan analysis, including MS/MS and bottom-up and top-down MS-based applications
* Experience with high-resolution mass spectrometry platforms such as the Waters Xevo G2-XS QTOF
* Experience with MS data analysis using MassLynx, UNIFI, Skyline and database search engine tools is highly desired
* Ability to obtain and maintain a security clearance


Candidates with these desired skills will be given preferential consideration:

* Experience with in-gel digestion, reversed phase mass spectrometry (RPLC MS), and size exclusion chromatography mass spectrometry (SEC MS)
* Ability to write complete reports and correspondence
* Ability to speak effectively in one-on-one and small group situations


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