Quality Control Scientist II

Quality Control Scientist IIJob ID: req4558Employee Type: exempt full-timeDivision: Biopharmaceutical Development ProgramFacility: Frederick: ATRFLocation: 8560 Progress Dr, Frederick, MD 21701 USAThe Frederick National Laboratory is 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. Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.PROGRAM DESCRIPTION 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.KEY ROLES/RESPONSIBILITIESAssay Development and QualificationWhere applicable, facilitate the transfer of analytical methods either into the BDP or out to a client/customerDevelopment of analytical methods used for R&D characterization, GMP release and/or stability testingEstablish specifications and control limits for in-process materials and final drug substance/productFacilitate the qualification or validation of new or updated assaysDevelop, revise and review SOPs, protocols and technical reportsResponsible for the analysis of assay performance through trend analysis, stability reports, and investigating analytical and bioassay method technical issuesSample TestingTesting of samples submitted for release or stability testing.Issue summary reports of testing, certificates of analysis/certificates of testing, and other data summary reportsReview QC test reports and data for compliance with established protocols and specificationsQualitySupport of QC functions (OOS, equipment logbooks, deviations, audits, investigations, CAPA, training, change control, and technical reports)Assist in the preparation of reports and data packages for interactions with regulatory agenciesLeadershipCommunication of key findings or method details with customers, as neededSupports training of staffServes as subject matter expert in flow cytometry and cell-based titer assessmentsCollaborates as a team member with strong adaptability, positive mindset and supportive attitude in multidisciplinary teamBASIC 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 a related field with hands-on laboratory experience in biomedical research/biotechnology/biopharmaceutical or related field. Foreign degrees must be evaluated for U.S. equivalency In addition to the education requirement, a minimum of two (2) years of related experienceDeep expertise with the development of flow cytometry and cell-based infectious titer methodsExtensive experience with cell culture methodologiesExperience with the development of ELISA-based assaysExperience with qPCR/ddPCR-based analysesBiotechnology field knowledge in analytical, biochemical, and immunological testingAbility to implement a rigorous testing program with appropriate operating procedures and cGMP complianceExperience in data evaluation, trending, and troubleshootingExcellent technical writing skillsKnowledge of the USP, ICH and FDA guidelines related to product testingKnowledge of GMPs, SOPs, good documentation practices and quality control operationsAbility to obtain and maintain a security clearancePREFERRED QUALIFICATIONSCandidates with these desired skills will be given preferential consideration: Experience working in a GMP environmentExperience with retroviral/lentiviral vector release testingUnderstanding of CAR-T cell therapeuticsPrior experience with analytical method qualification/validationBackground in immunology, with demonstrated application to assay development or cell-based systemsUnderstanding of equipment IQ/OQ/PQProficiency with Microsoft Office, data analysis software, and other lab related applicationsStrong written and verbal communication skills.4 years post-doctoral experience in a lead/supervisory roleExperience with next generation sequencingJOB HAZARDSThis position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations.Commitment to Non-DiscriminationAll qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.Pay and BenefitsPay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here84,500.00 - 121,124.00 USDThe posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions