Bristol Myers Squibb

Pharmaceutical

Manager,CMCDocumentation

$115–140k New Brunswick, New Jersey, United States FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Manager candidates.

The Brief

“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.

Pharmaceutical
Problems you'll solve

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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