Bristol Myers Squibb
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 careers.bms.com/working-with-us.
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.
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 careers.bms.com/working-with-us
Position Summary
BMS External Manufacturing is looking to recruit a permanent Tech Transfer Lead for Manufacturing Sciences and Technology (MS&T) Drug Substance (DS) External Manufacturing (ExM). Reporting to the Associate Director of MS&T DS ExM, the Tech Transfer Lead 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 drug substance 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. This position will build collaborations with Manufacturing, Quality, Supply Chain and Global Regulatory Sciences groups. As part of MS&T, this position offers the opportunity to provide strong leadership of cross-functional teams to address critical business objectives. The ideal candidate for this role has experience leading tech transfers within biologics manufacturing operations.
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
- The successful candidate must possess a science or engineering degree in the biotechnology, biochemical, chemical, or related disciplines, along with experience in commercial biologics manufacturing PhD (>7yrs), MS (>9yrs), BS (>12yrs), documented by a solid history of technical accomplishments.
- 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.
- Proven ability to apply risk-based thinking to resolve issues and drive decisions while maintaining a strong compliance focus is also 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.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 engagement, and it enhances the Company culture.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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