Quality Control Scientist II

About the role

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. The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. and addresses some of the most urgent and intractable problems in the biomedical sciences.

Responsibilities

• Assay Development and Qualification: facilitate the transfer of analytical methods, develop analytical methods, establish specifications and control limits, and facilitate the qualification or validation of new or updated assays
• Sample Testing: testing of samples, issue summary reports, review QC test reports and data for compliance
• Quality Support: support QC functions, assist in preparation of reports and data packages for regulatory agencies
• Leadership: communicate key findings, support training of staff, serve as subject matter expert in flow cytometry and cell-based titer assessments

Requirements

• Possession of a PhD degree from an accredited college or university in a related field with hands-on laboratory experience
• Minimum of two (2) years of related experience
• Deep expertise with the development of flow cytometry and cell-based infectious titer methods
• Experience with cell culture methodologies, ELISA-based assays, qPCR/ddPCR-based analyses, and biotechnology field knowledge
• Ability to implement a rigorous testing program with cGMP compliance and excellent technical writing skills

Qualifications

• Preferred candidates will have experience working in a GMP environment, retroviral/lentiviral vector release testing, CAR-T cell therapeutics, and analytical method qualification/validation
• Background in immunology, understanding of equipment IQ/OQ/PQ, and proficiency with Microsoft Office and data analysis software are also preferred

Skills

• Technical writing skills, knowledge of USP, ICH, and FDA guidelines, and ability to obtain and maintain a security clearance
• Strong written and verbal communication skills, experience with next generation sequencing, and 4 years post-doctoral experience in a lead/supervisory role

Benefits

Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave, and Retirement.

Pay

The posted pay range for this job is $84,500.00 - $121,124.00 USD, which is a general guideline and not a guarantee of compensation or salary.