Bristol Myers Squibb
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 SummaryThe Senior Manager, CMC Documentation & Specifications will join our team located in New Brunswick, New Jersey.
The successful candidate excels in organic chemistry, biological sciences, biochemistry, and/or pharmaceutical sciences and has experience in pharma and/or biologics CMC drug substance and/or drug product development.
This role will be performed in close collaboration with other groups within Analytical Strategy & Operations as well as the following departments:
Chemical Process Development, Drug Product Development, Portfolio Strategy & Integration, Manufacturing Science & Technology, Clinical Supply Operations, Nonclinical Safety, and Global Regulatory Sciences (GRS-CMC).
Key ResponsibilitiesThis position involves coordinating filing activities, compiling information from scientists, and authoring the CMC sections of regulatory documents (e.
g.
, IND/CTA, NDA/BLA) to support the timely submissions of both investigational and marketing applications for small and large molecules.
Responsibilities also include leading specification activities for small molecules and coordinating the assembly of prompt and accurate technical responses to inquiries from global Health Authorities on the CMC sections of regulatory documents.
A successful candidate will be responsible for providing feedback to the CMC Development Team on CMC issues and developing the writing strategy and timelines for the completion of the CMC sections of regulatory documents.
This position deals with complex issues using critical analysis and scientific judgment to solve problems.
Qualifications & ExperienceA Ph.
D.
or M.
S.
in organic chemistry or related disciplines with 7-10 years of pharmaceutical development experience is preferred.
The level of the position may be evaluated against the experience of the candidate.
This position involves knowledge of fundamental principles of organic chemistry, biological sciences, biochemistry, and/or pharmaceutical sciences, experience in pharma or biologics drug substance and/or drug product CMC development, and the critical evaluation of analytical data.
A successful candidate is expected to formulate and drive global regulatory writing strategy for CMC submissions, pay scrupulous attention to detail, to proactively identify key issues, to negotiate the delivery of approved technical documents in accordance with project timelines, and to respond to CMC development opportunities.
The candidate should have excellent verbal and written communication skills and interpersonal skills.
This position requires constructive interactions with other members of a team to approach problem solving.
Familiarity with computer-assisted document preparation tools is highly desirable.
#LI-OnsiteIf 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(TM) , 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.
About the Company:
Bristol Myers Squibb.
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.
Position SummaryThe Senior Manager, CMC Documentation & Specifications will join our team located in New Brunswick, New Jersey.
The successful candidate excels in organic chemistry, biological sciences, biochemistry, and/or pharmaceutical sciences and has experience in pharma and/or biologics CMC drug substance and/or drug product development.
This role will be performed in close collaboration with other groups within Analytical Strategy & Operations as well as the following departments:
Chemical Process Development, Drug Product Development, Portfolio Strategy & Integration, Manufacturing Science & Technology, Clinical Supply Operations, Nonclinical Safety, and Global Regulatory Sciences (GRS-CMC).
Key ResponsibilitiesThis position involves coordinating filing activities, compiling information from scientists, and authoring the CMC sections of regulatory documents (e.
g.
, IND/CTA, NDA/BLA) to support the timely submissions of both investigational and marketing applications for small and large molecules.
Responsibilities also include leading specification activities for small molecules and coordinating the assembly of prompt and accurate technical responses to inquiries from global Health Authorities on the CMC sections of regulatory documents.
A successful candidate will be responsible for providing feedback to the CMC Development Team on CMC issues and developing the writing strategy and timelines for the completion of the CMC sections of regulatory documents.
This position deals with complex issues using critical analysis and scientific judgment to solve problems.
Qualifications & ExperienceA Ph.
D.
or M.
S.
in organic chemistry or related disciplines with 7-10 years of pharmaceutical development experience is preferred.
The level of the position may be evaluated against the experience of the candidate.
This position involves knowledge of fundamental principles of organic chemistry, biological sciences, biochemistry, and/or pharmaceutical sciences, experience in pharma or biologics drug substance and/or drug product CMC development, and the critical evaluation of analytical data.
A successful candidate is expected to formulate and drive global regulatory writing strategy for CMC submissions, pay scrupulous attention to detail, to proactively identify key issues, to negotiate the delivery of approved technical documents in accordance with project timelines, and to respond to CMC development opportunities.
The candidate should have excellent verbal and written communication skills and interpersonal skills.
This position requires constructive interactions with other members of a team to approach problem solving.
Familiarity with computer-assisted document preparation tools is highly desirable.
#LI-OnsiteIf 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(TM) , 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.
About the Company:
Bristol Myers Squibb.
Estimated Salary: $20 to $28 per hour based on qualifications.
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