Senior Cmc Manager

$118,800.00-$196,200.00

The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursueour missionat MSK and around the globe. 

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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-POSTHYBRID Onsite twice a week at 633 3rd Avenue, NYC

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

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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.  

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