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Organization Overview:
The TS/MS Parenteral Pilot Plant is a group of skilled engineers and scientists who possess deep technical expertise in the manufacture of parenteral products. The pilot plant partners with site process engineers, TS/MS scientists, and development engineers and scientists to drive process improvements, troubleshoot process issues, evaluate new technologies, and ensure compliance with quality standards.
Responsibilities:
The Sr. Principal Scientist / Advisor for the TS/MS Parenteral Pilot Plant must be an experienced technical professional (scientist or engineer) with 5+ years of experience in parenteral manufacturing or development. This global TS/MS role will provide day-to-day support for pilot plant operations with a focus on isolator technology. This position requires a deep understanding of engineering first principles and the ability to design and fabricate lab-scale and pilot-scale models.
Collaborate with cross-functional teams in manufacturing and development to troubleshoot process issues, scale-up new development processes, aid in technology transfer, and evaluate new technologies.
Partner with development scientists and engineers to develop process operations and manufacturability of different molecules and platforms.
Partner with manufacturing sites (internal and external) to solve current manufacturing issues and work on long term solutions. Lead and support efforts to drive optimization and reliability of unit operations.
Participate in technology transfer activities from development to commercial site or between commercial sites, ensuring successful scale-up and process validation.
Prepare study protocols and tickets that align with pilot plant processes and procedures to meet customer needs.
Actively seeks and engages in discussions and decisions regarding emerging technologies that may be applied to develop and control processes.
Prepares technical reports and summary packages as necessary to ensure appropriate retrievable documentation of study conclusions.
Basic Requirements:
Bachelor of Science Degree in Chemical Engineering or degree in scientific field with good understanding of engineering first principles.
Minimum 5+ years of experience in parenteral manufacturing, pilot plants, or process development.
Fluent in written and spoken English.
Additional Skills/Preferences:
Understand regulatory requirements.
Ability to work well independently and in teams.
Experience with isolator technologies.
Understanding of statistical concepts and experimental design.
Additional Information:
The position is based out of Greenfield, IN.
Flexible schedule as some activities may require occasional support outside normal hours.
Ability to travel (< 10%) supporting US and OUS projects.
Business title will vary depending on level.
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