Senior Scientist​/Engineer, Manufacturing Technology Devens - MA - US R1604226 Posted ago

Position: Senior Scientist/Engineer, Manufacturing Technology Devens - MA - US R1604226 Posted 2 hours ago
## Senior Scientist/Engineer, Manufacturing Technology Devens - MA - USFind out how well you match with this job
** Working with Us
** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more:
** 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.
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