Senior CMC Manager

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Job details

We have an exciting opportunity for a Senior CMC Manager in the Office of Technology Development (OTD). At Memorial Sloan Kettering's (MSK), outstanding teams of scientists and clinicians work together on groundbreaking research that can lead to new cancer diagnostic and therapeutic inventions. Our mission is to ensure that inventions have the greatest chance of being developed and commercialized so that they both benefit patients and return the most value to MSK. You will play a major role in this mission by formulating and proposing phase-appropriate CMC development strategies, supporting internal core facilities for batch manufacturing and process/raw material changes, and leading or coordinating the delivery of CMC data packages to meet the regulatory expectations for new and approved IND.

You will:

• Plan and design CMC studies and support clinical manufacturing.

• Be a Subject-Matter-Expert in CMC, acting as a resource for acting as a resource for investigators, manufacturing facilities, and licensing managers for scientific and strategic input.

• Participate in non-clinical IND-enabling studies and ensure these studies are adequately supported by CMC data packages.

• Lead/support internal and external stakeholders to plan and implement CMC strategies and ensure studies and batch manufacturing are conducted adequately to support product quality profile.

• Support change control, and deviation management during product manufacturing to comply with regulatory expectations.

• Plan and establish new CMC packages for new INDs or IND amendments on time.

• Lead preparation of briefing documents and pre-meeting packages for FDA meetings

• Maintain current knowledge of regulations and guidelines (FDA, ICH, and others as the need arises)

You have:

• A minimum of 7 years' experience in CMC product development in the pharmaceutical/biotech industry or related industry.

• Experience in early-stage development of Biologicals and/or Cell/Gene Therapy is a plus.

• Experience in authoring regulatory submissions including INDs and proven understanding of eCTD elements and structure.

• Strong attention to detail.

• Strong interpersonal skills including verbal and written communication.

#LI-HYBRID#LI-POST HYBRID Onsite twice a week at 633 3rd Avenue, NYC

Are you ready to learn more about our Benefits?

Pay Range: $118,800.00-$196,200.00

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