Job#: 1296826Job Description:Key responsibilities:Work in an analytical group equipped with liquid chromatography systems and mass spectrometry platformsPrepare samples and perform analytical methods for analysis of therapeutic proteins and oligonucleotides with emphasis on liquid chromatography and mass spectrometryProvide MS support for large molecule characterization in drug substance and drug product process development, and collect MS data to be used for regulatory submissionsAuthoring reports and certificates of analysis.Understanding of regulatory expectations for analytical methods, control and stability strategy and comparability in a GxP environment.Work collaboratively with other scientists.Keep current with field of expertise and evaluate emerging analytical technologyAdditional responsibilities:Maintains laboratory facilities in accordance with company policies and industry best practices.Identifies, implements, and qualifies, as necessary, equipment to meet industrial best practices or achieve compliance with regulatory expectations.Preferred Qualifications:Bachelor's degree in Chemistry or Biochemistry0-2 years experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method developmentDocumented theoretical knowledge and hand-on experience in large molecule LC-MS analysisHands-on experience of operating Waters Xevo Q-TOF Mass Spectrometers and Waters UPLCsFamiliarity with commonly observed product quality attributes associated with therapeutic proteins (such as fragmentation, deamidation, oxidation, partial reduction etc.), and their characterization and quantification toolsPrior experience authoring or contributing to regulatory filingsWorking independently in advancing projects and studies within required deadlinesExcellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary environmentFor immediate consideration, email Donna at with a copy of your resume, as well as subject line, "Scientist BioPhysical - NC"EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or