Senior Expert/Associate Director, Analytical Project Lead

Novartis Services Incorporated • East Hanover, NJ • 3h ago

Job Description SummaryPosition is located in East Hanover, NJ LI #hybrid Pioneering New Frontiers: At Novartis, our mission in Cell Therapy Analytical Development and Operations is to innovate for patient benefit. We are seeking an inspiring Senior Expert or Associate Director to join our Analytical Project Leads team as an Analytical Project Lead. In this critical role, you will orchestrate the Analytical CMC strategies for various stages of cell therapy products, significantly contributing to the development and commercialization of groundbreaking CAR-T therapies. Your impact: As the Analytical Project Lead, you will be instrumental in developing and driving analytical strategies, ensuring seamless execution, and managing cross-functional communication across Cell Therapy programs from Inception to commercialization. Job DescriptionKey Responsibilities: Develop and oversee end-to-end analytical strategies for the assigned Cell Therapy Program(s), including analytical method development, validation, transfer, product characterization and CQA assessment, specification and release, etc. Represent Cell Therapy Analytical function in program CMC meetings, providing updates and sharing key takeaways. Act as a liaison between Analytical Development, Analytical Operations, Technical Operations, and the Regulatory CMC team to streamline execution of analytical deliverables. Regularly prepare and deliver program updates to various stakeholders. Assess resources and budget needs for program key milestones including process/product characterization, method externalization, and internal resource allocation. Manage scope, timelines, and budget activities with external analytical laboratories. Provide technical expertise and leadership as you collaborate within and across cross-functional teams to support process development and establish control strategy. Provide strategic recommendations across the network. Develop strategies to address analytical-related questions from health authorities, which include drafting, reviewing, and revising responses prepared by subject matter experts. Serve as the change control owner for method updates and specification revisions. Build and maintain robust relationships with key partners and stakeholders.What you'll bring to the role:This is a dual posting. The final level & title of the offer role would be determined by the hiring team based on the skills, experience & capabilities required to perform the role at the level the role has been offered (Senior Expert/Associate Director): Essential: For Senior Expert level, BS with 8+ years in relevant field, MS with 6+ years, or Ph.D. with 4+ years of analytical experience in biotechnology/pharmaceutical industry. For Associate Director level, BS with 12+ years in relevant field, MS with 8+ years, or Ph.D. with 6+ years of analytical experience in biotechnology/pharmaceutical industry. Proven track record in late phase development, commercialization, and life cycle management of biologic/cell therapy products. A critical thinking mindset, problem-solving skills, and interpersonal communication, scientific writing, and presentation abilities to provide effective leadership. Strong organizational skills and ability to prioritize simultaneous projects and activities. Passion for continuous learning and capability to work in a highly dynamic, fast-paced, collaborative environment is key to the success of this role. Desirable: \Cell Therapy experience is highly desired; Biologics experience is also considered.Experience with analytical support for biologic product commercialization, especially in cell/gene therapy field. \ Hands-on interest and experience in relevant analytical methods. Experience in regulatory filing and addressing health authority questions, and other correspondence/interactions with regulatory agencies Program management experience. Famil

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