NewBrunswickRecruiter Since 2001
the smart solution for New Brunswick jobs

Senior CMC Documentation Scientist

Company: Bristol-Myers Squibb Company
Location: New Brunswick
Posted on: November 9, 2019

Job Description:

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 of small and large molecules. Responsibilities also include coordinating the assembly of prompt and accurate technical responses to inquiries from the FDA and other regulatory agencies on the CMC sections of regulatory documents. These tasks will be performed in close collaboration with the following departments: Chemical & Synthetic Development, Drug Product Science and Technology, Analytical & Strategy Operations, Global Manufacturing and Supply, Drug Safety Evaluation, and Global Regulatory Sciences (GRS-CMC). A successful candidate will also be responsible for providing feedback to the Integrated Development Team on CMC issues and developing timelines for the completion of the CMC sections of regulatory documents. This position involves the critical evaluation of analytical data, knowledge of fundamental principles of organic chemistry and/or pharmaceutical sciences, and experience in drug product and/or drug substance CMC development. A successful candidate is expected to pay scrupulous attention to detail, toidentify proactively 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, as well as scientific judgement 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. A Ph.D. or M.S in Pharmaceutics, Organic Chemistry, Biochemistry, or related disciplines with3-5 years of pharmaceutical development experience is preferred.

Keywords: Bristol-Myers Squibb Company, New Brunswick , Senior CMC Documentation Scientist, Other , New Brunswick, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Residences Porter - The Ritz-Carlton New York, Westchester - (19107610)
Description: Residences Porter At more than 80 award-winning properties worldwide, The Ritz-Carlton Ladies and Gentlemen create experiences so exceptional that long after a guest stays with us, the experience stays (more...)
Company: Marriott International, Inc.
Location: White Plains
Posted on: 11/22/2019

Kiehls Customer Representative
Description: Kiehl's Since 1851 was founded as an old-world apothecary in New York's Lower East Side neighborhood. From our earliest days, our staff has personalized every contact with a Kiehl's customer. Our
Company: AllWork
Location: White Plains
Posted on: 11/22/2019

Sr. Internal Auditor - White Plains
Description: Ref ID: 02970-0011011099Classification: Sr. Internal AuditorCompensation: 80000.00 to 100000.00 yearlyRobert Half Finance and Accounting is searching for a Sr. Internal Auditor for a Westchester based (more...)
Company: Robert Half Finance & Accounting
Location: White Plains
Posted on: 11/22/2019


Grocery Delivery (Car Required)
Description: FULL-SERVICE SHOPPER Why shop and deliver with Instacart Instacart is the North American leader in grocery delivery. We strive to help make grocery delivery effortless, affordable, and accessible to (more...)
Company: Instacart
Location: White Plains
Posted on: 11/22/2019

Accounts Payable Clerk - White Plains
Description: Ref ID: 02970-9502293458Classification: Accounts Payable ClerkCompensation: 22.00 to 27.50 hourlyInternational Company seeks a temporary-to-full-time Accounts Payable A/P Clerk to become an integral (more...)
Company: Accountemps
Location: White Plains
Posted on: 11/22/2019

Food Store Delivery (Car Required)
Description: FULL-SERVICE SHOPPERWhy shop and deliver with Instacart Instacart is the North American leader in grocery delivery. We strive to help make grocery delivery effortless, affordable, and accessible to everyone. (more...)
Company: Instacart
Location: White Plains
Posted on: 11/22/2019

Customer Care Representative
Description: Full Time Customer Care Specialist We are hiring a Full Time Customer Care Specialist to deliver world class white glove service to every customer. The Customer Care Specialist will provide the highest (more...)
Company: Advantage Solutions
Location: White Plains
Posted on: 11/22/2019

Grocery Shopper team member (car required)
Description: FULL-SERVICE SHOPPER Why shop and deliver with Instacart Instacart is the North American leader in grocery delivery. We strive to help make grocery delivery effortless, affordable, and accessible to (more...)
Company: Instacart
Location: White Plains
Posted on: 11/22/2019

Audit Senior - White Plains
Description: Ref ID: 02970-9502312963Classification: Audit SeniorCompensation: 45.00 to 55.00 hourlyOur Professional Services client in Westchester County is seeking an interim Audit Senior. Ths interim Audit Senior (more...)
Company: Robert Half Management Resources
Location: White Plains
Posted on: 11/22/2019

Instacart Shopper (car required)
Description: FULL-SERVICE SHOPPER Why shop and deliver with Instacart Instacart is the North American leader in grocery delivery. We strive to help make grocery delivery effortless, affordable, and accessible to (more...)
Company: Instacart
Location: White Plains
Posted on: 11/22/2019

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

New Brunswick RSS job feeds