Good Laboratory Practice (GLP) Manager, Antitumor Assessment Core Facility (2024)

Overview: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 pursue our mission at MSK and around the globe. Please review important announcements about vaccination requirements and our upcoming EHR implementation by clicking here.Important Note for MSK Employees: Your Career Hub profile is submitted to the hiring team as your internal resume. Please be sure your profile is fully complete with your skills, relevant experience and education (if required). Click here to learn more. Please note, this link is only accessible for MSK employees. Responsibilities: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 pharmaco*kinetic (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 individualKey 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 requiredCore 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 essentialAdditional Information: #LI-Onsite #ZIPHP #INDHours: Monday - Friday, 9 am - 5 pm Location: 417 E. 68th Street Reporting to: Dr. Elisa de Stanchina, Facility HeadPay Range: $88,800.00-$142,200.00 Helpful Links: * MSK Compensation Philosophy* Review Our Greats Benefits OfferingsQualifications: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.