Diati Staffing
Analytical Scientist
Diati Staffing, Germantown, Maryland, United States
The qualified individual should have experience in sample testing and product characterization using electrophoretic technologies such as SDS-PAGE, pH, total protein analysis including A280 and Western Blot. Experience or knowledge on other analytical technology such as PCR based assays is a plus. Responsibilities include but not limited to: Follow SOP to test in-process samples using SDS-PAGE densitometry, Western Blot, pH, and Total Protein via A280 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 and Western Blot assays. Participate in qualification of in-process assays. Present sample testing data at internal meetings. Thoroughly analyze results and methods, solve analytical problems, troubleshoot assays and meet experimental expectations for analytics. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Maintain effective communication within Analytical Development and cross-functional teams. Present scientific findings at internal and external meetings (if applicable). Minimal Requirements: MS in analytical science, chemistry, biochemistry, or related field with 4 years of industry experience in biopharmaceutical and/or vaccine development. BS in analytical science, chemistry, biochemistry, or related field with 6 years of industry experience in biopharmaceutical and/or vaccine development. Ability to critically analyze data using statistical tools and to compile and review technical reports. Ability to define priorities and process to get things done. Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) is preferred. Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements. Good understanding of statistical tools and knowledge of DOE (Design of Experiments) and QbD (Quality by Design) principles is a plus. Strong communication, presentation, and writing skills.