Career Category

Operations

Job Description

Responsible for developing, qualifying and transferring state-of-the-art and fit-for-purpose quantitative potency and characterization assays and supporting regulatory submissions. Responsibilities include: Implementing state-of-the-art and fit-for-purpose analytical methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations. Preparing technical reports for investigations, product and impurity characterization, and regulatory submissions Generating and analyzing analytical data to support: product development investigations, 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 Supporting analytical projects involving method development, qualification, and transfer.

Basic Qualifications:

• Master’s degree

OR

• Bachelor’s degree and 2 years of experience

Preferred Qualifications:

• Master’s degree in Life Sciences Expertise in cell culture, and cell biology techniques for quantitative determination of biological activity of proteins
• Expertise in cell-based bioassay development (method characterization, 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 insights and initiatives, detail oriented documentation skills
• Experience with automated liquid handling Client orientation
• Establishes effective relationships with all clients; ensures value is delivered
• Communication and Interpersonal skills: communicates optimally, using appropriate tact and sensitivity; makes others feel valued and understood; works well in teams.

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