Principal Scientist, Manufacturing Technology Devens - MA - US R1604227 Posted ago

Position: Principal Scientist, Manufacturing Technology Devens - MA - US R1604227 Posted 2 hours ago
## Principal Scientist, 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:
** Principal Scientist, Manufacturing Technology
** 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 Director, Manufacturing Technology, and will directly support the Process Transfer and Validation group within the Manufacturing Technology organization. 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.

The role may require direct manufacturing support during campaign execution.
** 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.
* Leads complex technical transfers to support BMS business objectives.  Specifically, serves as a functional technical transfer lead and/or a workstream lead (as required) supporting the Devens 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…