Scientist/Senior Scientist, Biologics Analytical Development

Proclinical is currently recruiting for a Scientist of Biologics Analytical Development with a leading pharmaceutical company located in Gaithersburg, MD. As the Biologics Analytical Development Scientist, you will make detailed observations, analyze data, interpret results, and exercise appropriate technical judgment in the design, execution, and interpretation of experiments.

Job Responsibilities:

• Develop immunoassays for analysis and biological characterization of virus-like particle and protein nanoparticle vaccine products.
• Responsible for preparation and characterization of host cell protein (HCP) standards and specific antibodies.
• Responsible for determination of process-related impurities. Perform characterization studies to understand potential impact of impurities on safety and immunogenicity.
• Apply new cutting-edge technologies for in-process testing and product biological characterization.
• Maintain effective communication with process development, formulation, QC, discovery, and their testing needs.
• Perform method qualification/validation, and method transfer to other departments (e.g. QC).
• Thoroughly analyze results and methods, solve analytical problems, and troubleshoot assays.
• Follow SOP to test in-process samples using SDS-PAGE densitometry, Western Blot, Octet BLI and ELISA to support process development and stability studies of nanoparticle vaccines.
• Analyze gel image data using Image Lab and document in-process testing data.
• Optimize and troubleshoot SDS-PAGE, Western Blot, Octet BLI and ELISA assays.
• Involve in qualification and validation of in-process assays.
• Present sample testing data at internal meetings.

Skills and Requirements:

• BS, MS or PhD in biology, chemistry, biochemistry or equivalent.
• Minimum of 2-3 years' experience in pharmaceutical, biologics, and/or vaccine development.
• Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements.
• Understanding GMP requirements and other FDA regulatory requirements associated with analytical testing of vaccine products or biologics.

If you are having difficulty in applying or if you have any questions, please contact Natasha Patel at (+1) 617-778-7319 or n.patel@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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