Senior Scientist/Engineer, Manufacturing Technology

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Position: Senior Scientist/Engineer, Manufacturing Technology (Process Transfer, Validation and Projects)

Location: Devens, MA

Position Summary

The Senior Scientist/Engineer 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 be responsible for supporting the authoring and execution of 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 supporting the 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.

• Working 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.

• Support the delivery of 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 in a relevant engineering or scientific discipline and 7–9 years of relevant experience, or a Master’s degree and 4–6 years of relevant experience, or a PhD and 2–4 years of relevant experience. A combination of education and experience may be considered where appropriate.

• Technical execution experience in a commercial technical support function is preferred (MS&T, MT, Manufacturing Engineering, or similar).  Experience with technology transfer, Process Performance Qualification is a plus.  The successful candidate should possess a working knowledge of global regulatory requirements related to the design and control of biologics drug substance processes.