Principal Scientist – Technology Transfer

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: Principal Scientist – Technology Transfer Location: New Brunswick, New Jersey Manager: Thomas Vella At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Position Summary The Principal Process Engineer/Scientist act as a technology transfer lead in the parenteral manufacturing MS&T group. You will be accountable for the technical work between the sending and receiving sites to ensure design and transfer of robust manufacturing processes for new products and key lifecycle parenteral products. You will be the principle expert and process owner for the end-to-end manufacturing process for liquids and lyophilized parenteral products at Bristol Myers Squibb. Ensures processes are designed and validated per applicable cGMPs, Bristol Myers Squibb 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. You will report into the Associate Director of Manufacturing Technology, Parenteral MS&T and is located in New Brunswick, New Jersey USA. 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 or authoring plans or templates as appropriate. Responsible to create, maintain and harmonize key tech transfer business processes. Partners with the site 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 exceed plant and company goals. 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 Bachelor’s degree in Pharmacy, Biochemistry, Chemical Engineering or related Pharmaceutical sciences. Seven (7) years of directly related experience in Technical Services work within the pharmaceutical industry. Three (3) years experience in parenteral manufacturing of protein therapeutics (biologics) strongly preferred, along with demonstrated knowledge of how these products behave in parenteral processes. Experience 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 different technical teams. Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing. Experience with 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 prompt, complex and changing environment. Excellent analytical, technical and experiences. Demonstrated management, sociable and ability to work in team. Strong mentor, with excellent people development skills and track record. Why You Should Apply Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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. 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. COVID-19 Information To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S. BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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 will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. 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