Quality Control Scientist II

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/RESPONSIBILITIES Assay Development and Qualification Where applicable, facilitate the transfer of analytical methods either into the BDP or out to a client/customer Development of analytical methods used for R D characterization, GMP release and/or stability testing Establish specifications and control limits for in-process materials and final drug substance/product Facilitate the qualification or validation of new or updated assays Develop, revise and review SOPs, protocols and technical reports Responsible for the analysis of assay performance through trend analysis, stability reports, and investigating analytical and bioassay method technical issues Sample Testing Testing of samples submitted for release or stability testing. Issue summary reports of testing, certificates of analysis/certificates of testing, and other data summary reports Review QC test reports and data for compliance with established protocols and specifications Quality Support 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 agencies Leadership Communication of key findings or method details with customers, as needed Supports training of staff Serves as subject matter expert in flow cytometry and cell-based titer assessments Collaborates as a team member with strong adaptability, positive mindset and supportive attitude in multidisciplinary team BASIC QUALIFICATIONS 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 a related field with ≥ 4 years of hands-on laboratory experience in biomedical research/biotechnology/biopharmaceutical or related field (more experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency In addition to the education requirement, a minimum of two (2) years of related experience Deep expertise with the development of flow cytometry and cell-based infectious titer methods Extensive experience with cell culture methodologies Experience with the development of ELISA-based assays Experience with qPCR/ddPCR-based analyses 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 Knowledge of the USP, ICH and FDA guidelines related to product testing Knowledge of GMPs, SOPs, good documentation practices and quality control operations Ability to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Candidates with these desired skills will be given preferential consideration: Experience working in a GMP environment Experience with retroviral/lentiviral vector release testing Understanding of CAR-T cell therapeutics Prior experience with analytical method qualification/validation Background in immunology, with demonstrated application to assay development or cell-based systems Understanding of equipment IQ/OQ/PQ Proficiency with Microsoft Office, data analysis software, and other lab related applications Strong written and verbal communication skills. 4 years post-doctoral experience in a lead/supervisory role Experience with next generation sequencing JOB HAZARDS This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations.