The Research and Technology Management team is seeking a Chemistry Manufacturing Control (CMC) Associate. 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.
The successful candidate will be an enthusiastic, highly motivated, and innovative individual who is excited to join the extraordinary teams of scientists and clinicians at MSK that are united in a common pursuit: to transform our understanding of cancer and how we care for those affected by the disease!
As a Chemistry Manufacturing Control Associate you will:
Participate in the writing of regulatory dossiers, specifically: CMC section of INDs, Technical summaries for IDEs/ IDE exemptions, CMC Annual Reports, CMC Information Amendments and CMC commitments to FDA during clinical development.
Independently conduct follow-up background research of the scientific literature.
Assist the team in transitioning to electronic submissions.
Maintain the Product Development Portfolio Electronic Database up-to-date, and specifically, the CMC dossier and MSK commitments to FDA requests/recommendations for clinically active product development.
Participate in development team meetings with investigators, laboratory, and clinical staff to provide guidance on CMC development.
Maintain and utilizes strong working knowledge of FDA regulations and guidances relating to the development and manufacture of investigational agents, including 21 CFR parts 210, 211, 312, 600s, 820, 1271 in order to serve as a resource to the PIs working on product development issues.
Keep track and studies new regulations and guidances relevant to CMC.
Attend FDA webinars relevant to CMC.
A Masters Degree in Health Sciences.
A Doctorate Degree preferred.
Excellent technical scientific writing and verbal communication skills required.
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.
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 28th 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 2018, as well as one of Glassdoor’s Employees’ Choice Best Place to Work for 2018. We’re treating cancer, one patient at a time. Join us and make a difference every day.