Quality Control Scientist II

About the role

The 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.

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)
• Aid 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
• 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

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
• 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

• 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.

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. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

Pay and Benefits

The 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

Company

A rewarding career with global impact

Whether you’re an expert in your field or just starting out, we have a career opportunity for you. We’re always looking for people to join us in fulfilling the mission of the Frederick National Laboratory: discovery, innovation, and success in the biomedical sciences.

Our team of 2,400+ scientists, technicians, administrators, and support staff work at the forefront of basic, translational, and preclinical science, with a focus on cancer, AIDS, and other infectious diseases.

We collaborate with colleagues across the National Cancer Institute, National Institutes of Allergy and Infectious Diseases, and others throughout the National Institutes of Health. We also engage with extramural investigators in academia, government and industry.

Your path to joining our team begins with the desire to work for the only national laboratory dedicated to biomedical research. Our employees share a common desire to help make a difference in cancer research and public health concerns. As you search for a career that fits your education, skills, and abilities, explore the core values that guide us and emphasize work-life balance.

Discover why joining the Frederick National Laboratory team could be the most important career step you take