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Regeneron Pharmaceuticals Drug Product Process Sciences Programs Specialist in East Greenbush, New York

We are currently looking to fill a Drug Product Programs Specialist (Control Strategies & Systems) position within our Drug Product Process Sciences team. This position will provide support for the design and development of drug product processes. The individual will craft and refine the processes from freeze/thaw through filling and inspection and will be part of a team responsible for industrialization, troubleshooting, and validation at manufacturing sites, both international and domestic.

In this role, a typical day might include the following:

  • Collaborating with multi-functional teams to define and execute drug product process development and technology transfer activities

  • Providing manufacturing process expertise to multi-functional teams

  • Designing and implementing scale-up strategies for drug product unit operations with a focus on process characterization, identification of critical process parameters and process optimization

  • Engaging in predictive modeling of relevant processes as needed, engaging external expertise as appropriate

  • Writing and reviewing product industrialization protocols and reports to support technology transfer and process validation

  • Supporting process investigations and product impact assessments for change controls and internal/external investigations

  • Maybe performing at-scale hands-on experiments and in-process testing to support process development and product industrialization

This role might be for you if you:

  • Have a background in aseptic processing, drug product development, or pharmaceutical development

  • You continuously seek to improve processes for improved performance

  • Can work independently or as part of a team

  • Are OK with occasional travel up to 20% of the time•

To be considered for this role you must hold a Bachelor’s degree in Science or Engineering with 0-2+ years of related experience for Associate level, 2+ years for Specialist level, 5+ years for Senior level. May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

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