Analytical Scientist: Protein Assays & Regulatory

Job Description

Responsibilities include:

Developing and implementing pioneering and fit-for-purpose analytical methods for: impurity release testing.
Generating, analyzing, and interpreting analytical data to support: product development investigations, and regulatory submissions
Keeps current in analytical development field including literature and technology development for groundbreaking and regulatory activities
Supporting analytical projects involving method development, qualification, and transfer
Provides critical evaluation of analytical data and results to support: product development (for Process Development, Quality, etc.), investigations and regulatory submissions
Participates in and contributes to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates and documentation.
Basic Qualifications
Master's degree & 2 years of Scientific experience
OR
Bachelor's degree & 4 years of Scientific experience

Preferred Qualifications:

Experience and expertise with protein assays, particularly ELISA as well as most common formats for measuring protein-protein interactions.
Experience and expertise with molecular biology, particularly qPCR and DNA isolation.

Experience with GDP documentation and Electronic Laboratory Notebook systems.
Experience and expertise with Microsoft Office software, particularly Word, PowerPoint and Excel.

Experience with ICH Guidelines
Innovation – positive approach to challenges; champions new insights and initiatives; brings out and applies others' creativity to improve unit performance
Communication – establishes and maintains effective communication mechanisms to keep staff appropriately advised; bridges communication between individuals, units and other organizations as necessary
Social skills – communicates optimally, using appropriate tact and sensitivity; makes others feel respected, valued and understood

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