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.