Principal Scientist Ms&t Ds Exm
vor 2 Wochen
**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 rich in diversity. Take your career farther than you thought possible.
**Position**: Principal Scientist MS&T Drug Substance External Manufacturing (Tech Transfer Lead)**:
**Location**: Boudry**:** 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 rich in diversity. Take your career farther than you thought possible.
**Position Summary**
**Key Responsibilities**
- Leads Biologics Drug Substance (DS) technology transfer projects for key lifecycle biologic DS products, including the establishment of the process/parameters for each unit operation of the process, and up until the completion of process performance qualification and subsequent CMC filing activities.
- Transferring, optimizing and troubleshooting product and manufacturing processes of DS.
- Performs Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies.
- Designs, prepares, and reviews technology transfer protocols, methods/processes, experimental and/or authoring plans and/or templates as appropriate. Responsible to create, maintain and harmonize key tech transfer business processes.
- Partners with the management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage. Partners with site operations to provide a DS manufacturing process that is sustainable for future product supply. Partners with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized manufacturing process.
- Representative on global supply strategy groups/site forums and to relevant stakeholders across the company.
- Leads, motivates, mentors, and develops team members to meet and exceed plant and company goals and objectives.
- Develops and maintains effective working relationships with other division groups in support of technology transfer, validation, and process support activities.
- Responsible to review and co-author key CMC sections.
- Requires approximately ~20% travel.
**Qualifications & Experience**
- Proven matrix leadership skills and capabilities are required for this position.
- Previous experience in a technical services role supporting commercial operations is essential.
- Experience in leading and executing technology transfers into DS commercial operations is essential.
- Proven ability to work on complex problems in which analysis of situations or data requires an in-depth evaluation of multiple factors is required.
- Demonstrated strong communication, organizational and project management skills are required for this role.
- Subject matter expert in Upstream and Downstream DS operations.
- Knowledge of SOPs and cGMPs and the ability to work and manage within a regulatory environment.
- Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug substance manufacturing processes.
- Strong oral and written communication skills.
- Ability to work within and lead cross-functional technical teams.
- Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing.
- Strong understanding of project management systems and tools is preferred.
- Excellent organizational skills and the ability to successfully manage a multitude of technical projects.
- Ability to work in a fast paced, complex and changing environment.
- Excellent analytical, technical and strategic thinking skills and experiences.
- Demonstrated management, interpersonal and teamwork skills. Strong mentor, with excellent people development skills and track record.
**Uniquely Interesting Work, Life-changing Careers**
**On-site Protocol**
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and en
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