Senior Principal Scientist, Biologics Method Lifecycle
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.
The Senior Principal Scientist will join the Biologics Method Lifecyle Team with responsibility for the lifecycle management of methods including transfer, validation, methods performance monitoring and troubleshooting.
In addition to being responsible for the lifecycle management of commercial methods, the Analytical Science & Technology (AS&T) team is responsible for creating and managing the analytical CMC strategies from late stage development throughout the product lifecycle, authoring and reviewing regulatory filings, and supporting global QC and manufacturing technology groups.
Role
Responsibilities:
Function as validation leader for analytical technical line and for analytical methods transfer.
Defines validation strategy and writes/reviews associated documents to ensure global compliance for analytical methods including HPLC, Gel and Capillary Electrophoresis, ELISA, Bioassay, Spectrophotometric and compendial methods.
Defines strategy that is scientifically sound, appropriate and incorporates industry and Health Authority best practices and expectations.
Partners with analytical development to achieve method readiness to initiate validation, write validation protocol, gather, and interprets data generated by analytical development/QC labs and writes/reviews validation reports.
Participates in execution of method validations and transfers within and outside of BMS.
Conduct periodic review of method validation and performance and work with team leader to design and execute remediation experiments and implement changes to new or existing commercial methods.
Works collaboratively across organization and sites for method readiness, transfer, performance, and troubleshooting in commercial environment.
Works closely with all AS&T team members to understand and support their deliverables to achieve organization goals.
Manages scientists involved in validation, methods transfer and method lifecycle, including laboratory work as appropriate.
Key Requirements:
PhD in biological sciences, chemistry or related scientific disciplines with 8-10 yrs.
relevant experienceMS or BS with 12
yrs relevant experienceIndustry experience in method development and validation in support of development and/or commercialization of BiopharmaceuticalsPeople leadership, inclusive of developing, managing staff and leading a team of scientists in a Quality environment.
CMC method lifecycle experience with emphasis on strategic thinking and HA interactions in a matrix environmentQC experience with emphasis on upskilling and innovation of commercial methods in a Quality environmentStrong stakeholder management and engagement skillsAnalytical method Tech Transfer leadershipAnalytical method Validation leadershipLeading and driving continuous improvement initiativesDevelopment experience and transition of clinical to commercial method lifecycle managementInvestigations leadership and technical support for QC, including methods performance and remediationsExperience with analytical comparability desiredExperience with specifications setting and management a plusManaging internal and external labs/SOW a plus#LI-HybridIf 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 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 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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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.
The Senior Principal Scientist will join the Biologics Method Lifecyle Team with responsibility for the lifecycle management of methods including transfer, validation, methods performance monitoring and troubleshooting.
In addition to being responsible for the lifecycle management of commercial methods, the Analytical Science & Technology (AS&T) team is responsible for creating and managing the analytical CMC strategies from late stage development throughout the product lifecycle, authoring and reviewing regulatory filings, and supporting global QC and manufacturing technology groups.
Role
Responsibilities:
Function as validation leader for analytical technical line and for analytical methods transfer.
Defines validation strategy and writes/reviews associated documents to ensure global compliance for analytical methods including HPLC, Gel and Capillary Electrophoresis, ELISA, Bioassay, Spectrophotometric and compendial methods.
Defines strategy that is scientifically sound, appropriate and incorporates industry and Health Authority best practices and expectations.
Partners with analytical development to achieve method readiness to initiate validation, write validation protocol, gather, and interprets data generated by analytical development/QC labs and writes/reviews validation reports.
Participates in execution of method validations and transfers within and outside of BMS.
Conduct periodic review of method validation and performance and work with team leader to design and execute remediation experiments and implement changes to new or existing commercial methods.
Works collaboratively across organization and sites for method readiness, transfer, performance, and troubleshooting in commercial environment.
Works closely with all AS&T team members to understand and support their deliverables to achieve organization goals.
Manages scientists involved in validation, methods transfer and method lifecycle, including laboratory work as appropriate.
Key Requirements:
PhD in biological sciences, chemistry or related scientific disciplines with 8-10 yrs.
relevant experienceMS or BS with 12
yrs relevant experienceIndustry experience in method development and validation in support of development and/or commercialization of BiopharmaceuticalsPeople leadership, inclusive of developing, managing staff and leading a team of scientists in a Quality environment.
CMC method lifecycle experience with emphasis on strategic thinking and HA interactions in a matrix environmentQC experience with emphasis on upskilling and innovation of commercial methods in a Quality environmentStrong stakeholder management and engagement skillsAnalytical method Tech Transfer leadershipAnalytical method Validation leadershipLeading and driving continuous improvement initiativesDevelopment experience and transition of clinical to commercial method lifecycle managementInvestigations leadership and technical support for QC, including methods performance and remediationsExperience with analytical comparability desiredExperience with specifications setting and management a plusManaging internal and external labs/SOW a plus#LI-HybridIf 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 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 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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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