Quality Control Scientist II

Frederick National Laboratory
Frederick, MD
Nov 23, 2021
Nov 26, 2021
Accountant, IT
Full Time
PROGRAM DESCRIPTIONThe 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.KEY ROLES/RESPONSIBILITIESIndependently 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 resultsPerform targeted protein identification, protein characterization and quantitative proteomics experiments from sample preparation, LC MS/MS data collection and data analysisDesign and develop LC-MS methodologies for viral vector-based therapies including AAV gene therapy product characterization and optimization of AAV platformsDevelop LC-MS based workflows for host-cell protein identificationResponsible for timely evaluation of QC samples and interpretation of dataMaintain accurate records of data. Keep accurate, clear, and updated notebooks and records with timely record all experimental findingsCommunicate results with summary sheets and present scientific results to the project teamsPerform other MS-based and non-MS-based experiments as needed to support analytical, CMC, and bioanalytical needsAuthor and review SOPs and technical reportsOther related duties as assignedBASIC QUALIFICATIONSTo 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 US equivalencyIn addition to the education requirement, a minimum of two (2) years of progressively responsible experienceExperience with specialization in Mass SpectroscopyPrior experience in GMP or Pharmaceutical industryMust have hands on experience with liquid chromatography and protein mass spectrometry with experience in analytical development for biotherapeutic candidatesExperience with protein characterization by intact protein analysis, peptide mapping and glycan analysis, including MS/MS and bottom-up and top-down MS-based applicationsExperience with high-resolution mass spectrometry platforms such as the Waters Xevo G2-XS QTOFExperience with MS data analysis using MassLynx, UNIFI, Skyline and database search engine tools is highly desiredAbility to obtain and maintain a security clearancePREFERRED QUALIFICATIONSCandidates 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 correspondenceAbility to speak effectively in one-on-one and small group situationsJOB HAZARDSThis position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations

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