CMC (Chemistry Manufacturing Control) Associate - Regulatory Oversight and Product Development

USA-NY-New York
2 months ago
Requisition ID
2017-16290
Category
Research - Other

Company Overview

At Memorial Sloan Kettering (MSK), we’re not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we’re driving excellence and improving outcomes.

 

For the 27th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker’s Healthcare list as one of the 150 Great Places to Work in Healthcare in 2016, as well as Glassdoor’s annual Employees’ Choice Awards 2017. We’re treating cancer, one patient at a time. Join us and make a difference every day.

Job Description

We are seeking a CMC (Chemistry Manufacturing Control) Associate for our team in Regulatory Oversight and Product Development.

In accordance with FDA and NIH regulation and guidance, the CMC Associate uses technical and scientific knowledge to conduct the appropriate analysis of CMC submission documents for investigational products (INDs for drugs, biologics and IDEs for devices) developed at MSK and is responsible for timely organization and writing of CMC annual reporting, amendments and commitments to the regulatory agencies throughout clinical development.

You need:

  • A Master’s degree in Health Sciences, Regulatory Science or Regulatory Affairs.
  • At least 2 years of experience in Oncology, or prior experience in translating an investigational product (drug or device).
  • A Doctorate in Biomedical Sciences, Pharmacy or related life Science preferred.
  • Excellent oral and written communication skills.
  • Ability to work independently as well as in a team.
  • Ability to analyze and provide constructive feedback on scientific data.
  • Ability to prioritize tasks, coordinate multiple projects and meet established deadlines.
  • Excellent computer and software skills (database management, spreadsheet, word processing and graphics applications).

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Closing

MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.  

 

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

 

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