What are the responsibilities and job description for the Senior Principal Scientist. Analytical Science position at Bristol Myers Squibb?
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
The Senior Principal Scientist in Analytical Science will be in the department of Global Quality Control Operations and Analytical Sciences. The incumbent will be responsible for leading multiple analytical aspects of a small molecule product throughout its commercial lifecycle. They will participate on cross-functional teams as the analytical representative on technical and CMC topics. The person is expected to have significant knowledge of small molecule API and drug product methods and experience working on commercial regulatory dossiers, health authority responses, as well as analytical CMC strategy. A strong understanding of GMP is required.
Key Responsibilities
Own the analytical lifecycle management of the BMS commercial small molecule products.
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
Responsibilities
BMS 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/ 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.
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
The Senior Principal Scientist in Analytical Science will be in the department of Global Quality Control Operations and Analytical Sciences. The incumbent will be responsible for leading multiple analytical aspects of a small molecule product throughout its commercial lifecycle. They will participate on cross-functional teams as the analytical representative on technical and CMC topics. The person is expected to have significant knowledge of small molecule API and drug product methods and experience working on commercial regulatory dossiers, health authority responses, as well as analytical CMC strategy. A strong understanding of GMP is required.
Key Responsibilities
Own the analytical lifecycle management of the BMS commercial small molecule products.
- Provide analytical subject matter expertise and overall lifecycle management of commercial release methods and specifications
- Participate on cross-functional teams as the analytical SME
- Support the commercial stability and reference standards groups
- May lead a matrixed team of commercial analytical scientists
- Collaborate with development teams to ensure analytical commercial readiness of late-phase projects (methods and specifications for the analytical overall control strategy)
- Implement methods for small molecule API, drug products, process intermediates, and regulatory starting materials at commercial QC testing sites.
- Lead method validations and validation gap assessments to ensure validations are up to current standards, perform method validation remediation, as necessary
- Lead method transfer to BMS or external QC laboratories for the purpose of globalization and lifecycle management (including bringing on new manufacturing sites)
- Write formal analytical documents such as validation protocols/reports, method transfer protocols/reports and investigations reports
- Provide expertise and guidance for problem-solving including method troubleshooting, laboratory investigations, deviations, and CAPA's,
- Collaborate with MS&T on continuous improvement initiatives
- Evaluate and participate in the review and implementation of compendia changes with impact to analytical methods
- Develop and execute on the analytical CMC strategy to globalize small molecule products
- Prepare and review technical documents
- Prepare and review analytical CMC sections of commercial regulatory submissions and address analytical-related inquiries from health authorities.
- Bachelor's degree in Chemistry or a related field with at least 12 years of experience or Master's degree in Chemistry or a related field with at least 10 years of experience or PhD in Chemistry or a related field with at least years 8 of experience
- Strong technology and scientific background in the application of analytical chemistry to small molecule CMC
- Advanced knowledge and understanding of cGMPs
- Experience working in or with QC laboratories
- Knowledge of analytical method development validation and transfer requirements
- Experience with regulatory / analytical CMC requirements
- Demonstrated ability to be SME for analytical trouble-shooting and problem-solving
- Experience in the authoring and reviewing technical documents, analytical sections of commercial regulatory files and responding to analytical health authority inquiries
- Overall awareness of the pharmaceutical manufacturing & quality processes and regulatory requirements necessary to manufacturing and distributing
- Basic understanding of small molecule formulation and API manufacturing processes
- Excellent written, verbal communication and interpersonal skills with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
- Ability to build strong, trusting relationships, and work across divisions, diverse business backgrounds and cultures.
- Some project management skills and ability to work on several products at the same time
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
Responsibilities
BMS 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/ 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.
