Process Development Associate Scientist- Biological and Structural Characterization

About the role

The Process Development Associate Scientist- Biological and Structural Characterization will develop, qualify and transfer state-of-the-art and fit-for-purpose quantitative potency and biological characterization assays and supporting sample testing and regulatory submissions.

Responsibilities

• Implementing state-of-the-art and fit-for-purpose analytical potency methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations
• Assisting in the preparation of technical reports for investigations, product and impurity characterization, and regulatory submissions
• Generating and analyzing analytical data to support: product development and regulatory submissions
• May contribute to critical analytical development teams (e.g., product and process development teams, product quality teams) by providing analytical updates, analytical documentation and data interpretation. Keeps current in analytical development field including literature and technology development. Supports analytical projects involving method development, qualification, and transfer

Requirements

• Master’s degree and 1 year of scientific experience
• OR Bachelor’s degree and 3 years of scientific experience

Qualifications

• Expertise in cell culture, and cell biology techniques for quantitative determination of biological activity of proteins
• Expertise in cell-based bioassay development (characterization methods, qualification, validation, technical transfer)
• Expertise with signal transduction, gene expression, receptor binding and fluorescent probe technologies
• Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines
• Innovation – supports new ideas and initiatives
• Detail oriented and excellent documentation skills
• Experience with automated liquid handling preferred
• Client orientation– establishes effective and responsive relationships with all clients; ensures value is delivered
• Communication and Interpersonal skills – communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood; works well in teams

Benefits

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Pay

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Schedule

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