Principal Scientist, Manufacturing Technology

About the role

The Principal Scientist is a subject matter expert and process/project owner for biologic drug substance commercial technical transfers, process validations and project portfolio at Bristol Myers Squibb, Devens. The position will serve as lead or critical support for commercial biologics technical transfers and will engage cross-functionally across multiple stakeholder functions.

Responsibilities

• Leadership and execution of biologics drug substance projects including commercial technology transfer, technical oversight of process design, process validation/re-validation, regulatory package authoring and successful inspection and approval for the Devens Biologics site.
• Supports the Devens site, MS&T and business unit priorities by leveraging technical ability, stakeholder management and excellent communication ability.
• Works with site support organizations (Manufacturing, Supply Chain, Digital Plant, Site Engineering, and Quality Assurance) to remove obstacles and ensure timely results.
• Drives effective working relationships with other functional organizations, such as Quality, Operations, Engineering, Global Regulatory Science, Technical Product Teams and others, both internally and externally to the site.

Requirements

• Bachelor’s degree in a relevant engineering or scientific discipline and 9–12 years of relevant experience, or a Master’s degree and 6–9 years of relevant experience, or a PhD and 4–6 years of relevant experience.
• Technical execution experience in technology transfer and Process Performance Qualification.
• Previous direct support of CMC filing activities is preferred.
• Understanding and knowledge of global regulatory requirements related to the design and control of biologics drug substance processes.
• Thorough knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, and process control fundamentals in technical transfer and post approval process changes.
• Excellent communication and presentation skills and vast experience interfacing with multiple stakeholders and partner functions.
• Strong understanding of project management systems and tools is preferred.
• Excellent organizational skills and the ability to successfully manage a multitude of technical projects.