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. 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 Manager, Chemistry, Manufacturing, and Controls (CMC) Documentation & Specifications will join our team located in New Brunswick, New Jersey as a technical author of CMC regulatory submissions and specification.
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, Biologics Development, Drug Product Development, Portfolio Strategy & Integration, Manufacturing Science & Technology, Clinical Supply Operations, Nonclinical Safety, and Global Regulatory Sciences.
This 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. An important component of the role is data verification to ensure high quality regulatory submissions.
A successful candidate is expected to author the approved technical documents in accordance with project timelines, proactively identify concerns, and provide feedback to the CMC Development Team on potential issues. This position requires the candidate to use critical analysis and scientific judgment to solve problems and pay scrupulous attention to detail.
A degree in organic chemistry, biological sciences, biochemistry, and/or pharmaceutical sciences, or related disciplines with a minimum of 5 years of pharmaceutical development experience is preferred. The level of the position may be evaluated against the experience of the candidate.
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.
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.
New Brunswick - NJ - US: $115,230 - $139,637
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit
Benefit Offerings Are Subject To The Terms And Conditions Of The Applicable Plans In Effect At The Time And May Require Enrollment. Our Benefits Include:
Paid Time Off
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
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 a supportive culture, promoting global participation 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.
BMS Has An 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 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:
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at ***email_hidden***. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
R1602794 : Manager, CMC Documentation
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. 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.
Benefit Offerings Are Subject To The Terms And Conditions Of The Applicable Plans In Effect At The Time And May Require Enrollment. Our Benefits Include:
Paid Time Off
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
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 a supportive culture, promoting global participation 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.
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 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:
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at ***email_hidden***. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
R1602794 : Manager, CMC Documentation
...creating beautiful desserts? Meticulously organized, yet able to work alone, self-motivated and cooperative? Do you have experience decorating cakes and yet still seek out and new ideas and methods to improve your craft? If any of these apply to you or you are interested in...
....25/hour Ages 18+. Pay may vary between position based on job responsibilities. At Cedar Point, work is FUN! Working as a Night Auditor means you will provide exception al service to all guests staying at one of our world class resorts . Youll also...
...to safetyMust hold a valid California Commercial Class A or Class B Drivers License with passenger endorsement Must have a driving record in Good Standing. To be in Good Standing Driver must present a current DMV printout report with none of the violations below...
...Title : Temporary Policy Review Specialist-Public Entity Insurance Location : Remote Job Type : Contract (6 Months + Possible Extensions) Compensation : $25 - $40/hr Industry: Insurance --- About the Role Our staffing firm is partnering with a large...
...Registered Nurse (RN) | Endoscopy Location: Durham, NC Agency: FlexCare Pay: $1,725 per week Shift Information: Days - 5 days x 8 hours Contract Duration: 13 Weeks Start Date: ASAP About the Position Position Details Profession:...