Principal Scientist
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 Summary**
The Principal Process Engineer/Scientist acts as a technology transfer lead in the parenteral manufacturing MS&T group. This position is accountable for the technical interface between the sending and receiving sites to ensure design and transfer of robust manufacturing processes for new products and key lifecycle parenteral products. Ensures processes are designed and validated per applicable cGMPs, BMS procedures, and that processes are defined consistent with regulatory filings. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices. The role will also be responsible for review and authoring of key CMC submissions, along with setting relevant standards and creating /maintaining associated tech transfer business processes.
**Key Responsibilities**
- Leads parenteral technology transfer projects for key lifecycle biologic parenteral 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.
- Development, characterization, optimization and troubleshooting product and manufacturing processes of parenteral dosage forms.
- 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 parenteral 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.
**Requirements**:
- Bachelor’s degree in Pharmacy, Biochemistry, Chemical Engineering or related Pharmaceutical sciences.
- Seven years of directly related experience in Technical Services work within the pharmaceutical industry.
- Three years experience in parenteral manufacturing of protein therapeutics (biologics) strongly preferred, along with demonstrated knowledge of how these products behave in parenteral processes.
- Subject matter expert in parenteral operations: aseptic processing, sterilization, sterile filtration, isolator technology, lyophilization, pre-filled syringe operations. Strong knowledge of global regulatory requirements related to the design and control of these processes.
- Knowledge of SOPs, cGMPs and GLPs 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 product 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
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