Working with UsChallenging. 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: R1589560 Senior Scientist, Drug Product ChampionManager: Melissa BentleyLocation : USA New Jersey, NBRWorking with UsChallenging. Meaningful. Life-changing. Those are not 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 will 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-usPosition SummaryThe Product Champion provides technical leadership related to new or existing sterile drug product(s). The Product Champion is responsible for a product(s) at one or more sites.This position is accountable for key life cycle management product(s), providing specialized expertise necessary to complement site capabilities for critical investigations, process improvement projects, technical transfer projects, etc.A product champion is responsible for leading a matrix Drug Product team, driving the drug product book of work, ensuring product robustness and process monitoring.Key Responsibilities
Lead Aseptic Drug Product matrix team for a sterile product(s). Represents DP on technical matters at TPT
Manages DP BOW and risk register.
Provides assistance to sites to resolve significant quality events, and provides input for complex change controls.
Informed on Local Change Controls. Endorse Global Change Controls and Responsible for Global Change Control Impact Assessments
Accountable and responsible for lifecycle documents such as Time Out of Refrigeration (TOR) and Process Description
Review and co-author sections of the CMC filings and Information Requests (IRs)
Review and co-author End to End Robustness and End to End Annual Product Quality Reviews. Accountable for robustness action plan.
Collaborate on TT project definition and support chartered projects.
Support Technology Transfers, providing input, reviewing/approving key documents.
Interact and engage with a core team of specialized experts with necessary capabilities to support the BMS portfolio of products and complement site capabilities.
Qualifications & ExperienceRequired:
Knowledge in Biologics/sterile liquid drug products, aseptic processing
Experience in Biologics/Vaccine Aseptic Drug Product Manufacturing and/or Technology Transfer
Ability to serve as a technical expert for a Drug Product manufacturing site
Strong critical thinking, technical writing, and verbal communication
Demonstrated ability to:
Work in a matrix environment and effectively support the decentralized manufacturing function.
Build alignment with business partners including analytical, regulatory, and manufacturing regional and site leaders.
Desired:
Experience in Lyophilization technology and ability to serve as technical expert for Lyophilization
Thorough knowledge of quality systems, Quality by Design, validation principles for product and engineering design and process control fundamentals
Education/Experience/ Licenses/Certifications:
Bachelor's degree with 5-9 years of relevant experience. Master and Ph.D. is preferred but not required. Time spent in advanced degree program may consider as equivalent experience.
Travel:
This position requires up to 30% of travel
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.If you come across a role that intrigues you but does not 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 CareersWith 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 ProtocolPhysical 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 reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodation/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.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 CareersWith 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 ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.Company: Bristol-Myers SquibbReq Number: R1589560Updated: 2025-02-22 02:32:46.220 UTCLocation: New Brunswick-NJBristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.