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

• Facilitate the transfer of analytical methods either into the BDP or out to a client/customer
• Develop analytical methods used for R&D characterization, GMP release and/or stability sing
• 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
• Test samples submitted for release or stability sing
• Issue summary reports of sing, certificates of analysis/certificates of sing, and other data summary reports
• Review QC reports and data for compliance with established protocols and specifications
• Support quality support of QC functions (OOS, equipment logbooks, deviations, audits, investigations, CAPA, training, change control, and technical reports)
• Aid in the preparation of reports and data packages for interactions with regulatory agencies
• Communicate key findings or method details with customers, as needed
• Serve as subject matter expert in flow cytometry and cell-based titer assessments
• Collaborate as a team member with strong adaptability, positive mindset and supportive attitude in multidisciplinary team

Basic Qualifications

• 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
• 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 sing
• Experience in data evaluation, trending, and troubleshooting
• Excellent technical writing skills
• Knowledge of the USP, ICH and FDA guidelines related to product sing
• Knowledge of GMPs, SOPs, good documentation practices and quality control operations
• Ability to implement a rigorous sing program with appropriate operating procedures and cGMP compliance
• Ability to obtain and maintain a security clearance

Preferred Qualifications

• Experience working in a GMP environment
• Understanding of retroviral/lentiviral vector release sing
• Understanding of CAR-T cell therapeutics
• Experience with next generation sequencing
• Experience with 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

Commitment to Non-Discrimination

All 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.

Pay And Benefits

The posted pay range for this job is $84,500.00 - $121,124.00 USD. 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.