Principal Scientist, Manufacturing Technology

Position Summary

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.

Key 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.
• Serves as a functional technical transfer lead and/or a workstream lead (as required) supporting the Devens site.
• Supports technical aspects of site regulatory inspections with thorough understanding of regulatory environment and industry trends for biologics drug substance specifically in relation to Pre-Approval Inspections (PAI) supporting technical transfer and post approval process changes.
• Delivers Devens site, MS&T and business unit priorities through influencing technical direction for biologics drug substance manufacturing across media/buffer, cell banking, cell culture, purification, formulation and fill through to freeze.
• 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.

Qualifications & Experience

• 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.