Good Laboratory Practice (GLP) Manager, Antitumor Assessment Core Facility at Memorial Sloan Kettering Cancer Center

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Exciting Opportunity at MSK: We are looking for a Good Laboratory Practice (GLP) & Quality Assurance Manager to support the Antitumor Assessment Core.

The Antitumor Assessment Core provides support for the early discovery of effective antitumor agents and therapeutics. The Core provides resources, professional and technical expertise, and advisory services related to the evaluation of agents with potential therapeutic activity. We work with investigators to establish preclinical models, including Patient-Derived Xenograft (PDX) and Patient-Derived Organoid (PDO) models, for the design and execution of pharmacokinetic (PK), toxicity, and in vivo efficacy studies. The Core also determines the best formulation, administration route, and treatment schedule for each new compound, either alone or in combination with other agents. As such, the Core provides a major vehicle to facilitate pre-clinical studies, including GLP-compliant safety toxicology studies in support of IND applications and is a major contributor to the translational mission of the Center.

Role Overview:

• Serve as the GLP study director, maintaining a database tracking progress and outstanding issues for all toxicology projects
• Along with Dr. de Stanchina, meets with Principal Investigators (PI) and their laboratory scientists to strategize the preclinical development of novel test articles
• Develop methods for the quantification of compounds in biological matrices via mass spectrometry
• Supervises the execution of PK studies, from in vivo steps to sample processing/run, conducts data analysis using dedicated software, and provides investigators with complete study reports
• Maintains the Facility in GLP compliance in terms of validation, environmental monitoring, equipment operations, reports, and general record-keeping
• Ensures the maintenance of a record of the qualifications, training, experience, and job description for each professional and technical individual

Key Qualifications:

• PhD. with a minimum of 3 years of experience in pre-clinical development and IND application preparation for FDA-regulated clinical trial investigational products is required. Ph.D. in a scientific area related to investigational drug/device development, e.g. Biology or Chemistry disciplines is preferred
• Thorough understanding of FDA regulations and guidelines for investigational product development and manufacturing, with particular attention to GLP regulation required
• Ability to prepare SOP documentation and FDA-appropriate laboratory procedure documents required

Core Skills:

• Detailed knowledge of bench-to-bedside and bedside-to-bench translational research processes
• Excellent written and verbal communication skills, including expertise with MS Office software including databases, statistical analysis, and presentation software essential

Additional Information: #LI-Onsite #ZIPHP #IND

Hours: Monday - Friday, 9 am - 5 pm

Location: 417 E. 68th Street

Reporting to: Dr. Elisa de Stanchina, Facility Head

Pay Range: $88,800.00-$142,200.00

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