Bristol Myers Squibb
Pharmaceutical
Manager,CMCDocumentation
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optimal for Manager candidates.
“Manager, CMC Documentation at Bristol Myers Squibb. Skills: CMC Documentation, Regulatory submissions, Specification development. Coordinate filing activities. Compile information from scientists”
What You'll Achieve.
Timely submissions of applications
Industry & Context.
Problem solving
What They're Looking For.
Must Have
5 years pharmaceutical development experience
Nice to Have
Degree in organic chemistry, Degree in biological sciences, Degree in biochemistry, Degree in pharmaceutical sciences, Degree in related disciplines, Familiarity with computer-assisted document preparation tools
What You'll Do.
Coordinate filing activities
Compile information from scientists
Author CMC sections of regulatory documents
Support investigational applications
Support marketing applications
Lead specification activities
Coordinate assembly of technical responses
Respond to Health Authority inquiries
Verify data for submissions
Author approved technical documents
Provide feedback to Development Team
Pay attention to detail
How You'll Work.
Team & Collaboration
Collaboration with Analytical Strategy & Operations; Collaboration with Chemical Process Development; Collaboration with Biologics Development; Collaboration with Drug Product Development; Collaboration with Portfolio Strategy & Integration; Collaboration with Manufacturing Science & Technology; Collaboration with Clinical Supply Operations; Collaboration with Nonclinical Safety; Collaboration with Global Regulatory Sciences; Interactions with team members
Communication Scope
Written communication; Verbal communication
Full Job Description
**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. 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](https://careers.bms.com/working-with-us). **Position Summary** 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. **Key Responsibilities** 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 suppor
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