Principal Scientist, Manufacturing Technology (Process Transfer, Validation and Projects)

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Position: Principal Scientist, Manufacturing Technology (Process Transfer, Validation and Projects) 

Location: Devens, MA

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.  The role will ensure processes are designed and validated per applicable current good manufacturing practices (cGMPs), site procedures, and that processes are defined consistent with regulatory guidance. The role will also be responsible for driving process validation protocols, reports and exceptions (as applicable), and for key sections of Chemistry, Manufacturing, and Controls (CMC) submissions, along with setting relevant standards and procedures.

This position will report to the Associate Director, Process Transfer and Validation. The successful candidate will leverage technical ability, stakeholder management and excellent communication ability to deliver Devens site, MS&T and business unit priorities.  They will work with site support organizations (Manufacturing, Supply Chain, Digital Plant, Site Engineering, and Quality Assurance) to remove obstacles and ensure timely results.

Key Responsibilities

• Responsible for the 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.

• Influences technical direction for biologics drug substance manufacturing across media/buffer, cell banking, cell culture, purification, formulation and fill through to freeze.

•  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.

• Lead complex technical projects within biologics drug substance manufacturing and drives decisions that require developing new options to solve highly complex and/or novel problems.

• Responsible for supporting 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.

• Is responsible for the timely delivery of assigned projects across technical transfer, process validation/qualification, and post approval process changes at Devens Biologics.

• Routinely interacts within the MS&T internal BMS network for technical and operational improvements and issue resolution.

• 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 or equivalent in relevant engineering or scientific discipline with extensive relevant experience. A minimum of 6 years is required.  A combination of education and experience may be acceptable.

• Technical execution experience in technology transfer and Process Performance Qualification.  Previous direct support of CMC filing activities is preferred.  Understandi