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Senior Scientist, Global Product Stability

Company Name:
Koch Davis
Deploy and sustain stability best practices toward successful development and manufacture of medical devices and combination products. Provide leadership/representation on multidisciplinary project teams as a global product stability group expert and a stability study director. Author stability strategies and protocols as needed. Maintain stability program procedures, work instructions, and templates. Ensure environmental chambers are maintained in accordance with FDA requirements. Ensure documentation in support of expiry dating is in alignment with company, industry and regulatory guidelines. Partner with other functions to identify and correct any product or process-related issues. Embrace a team-oriented environment conducive to change, appropriate risk-taking, and flexibility.
Requirements
At least 2 years of medical device or pharmaceutical experience is required. Working knowledge of stability operations and industry best practices are required. Working knowledge of medical device regulations and pharmaceutical regulations, standards, and guidances are required. Must have excellent verbal and written communication skills.
Education
B.S., M.S. or a Ph.D. in a science discipline
Client
This is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer company.

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