Associate Director – Cell Therapy Analytical Project Lead

Novartis • East Hanover, NJ

1d • Onsite

About The Position

At Novartis, our mission in Cell Therapy Analytical Development and Operations is to innovate for patient benefit. We are seeking an inspiring Associate Director to join our Analytical Project Leads team as an Analytical Project Lead. In this critical role, you will be instrumental in developing and driving analytical strategies, ensuring seamless execution, and managing cross-functional communication, significantly contributing to the development and commercialization of groundbreaking CAR-T therapies.

Requirements

• BS with 12+ years, MS with 8+ years, or PhD with 6+ years of analytical experience in the biotechnology/pharmaceutical industry
• Prior cell therapy and technical program management experience preferred.
• Demonstrated track record in early- and late-stage development, commercialization, and life cycle management of biologic and/or cell therapy products.
• Strong critical thinking and problem-solving skills, along with excellent interpersonal communication, scientific writing, and presentation abilities to effectively lead and influence.
• Exceptional organizational skills and the ability to prioritize and manage multiple projects and activities concurrently.
• Passion for continuous learning and a proven ability to thrive in a highly dynamic, fast-paced, and collaborative environment.

Nice To Haves

• prior cell therapy and technical program management experience

Responsibilities

• Lead the end-to-end analytical strategy for assigned Cell Therapy program(s), including method development, validation, transfer, product characterization, CQA assessment, specifications, and release.
• Represent the Cell Therapy Analytical function in CMC program meetings, providing clear updates and key takeaways.
• Serve as a primary liaison between Analytical Development, Analytical Operations, Technical Operations, and Regulatory CMC to streamline analytical deliverables.
• Regularly prepare and present program updates to various internal stakeholders and governance bodies.
• Assess resource and budget needs to support key program milestones, including process/product characterization, method externalization, and internal resource planning.
• Oversee scope, timelines, and budget for activities conducted at external analytical laboratories.
• Provide technical expertise and strategic leadership within Technical Development and across cross-functional teams to drive product advancement.
• Serve as owner of product specifications and associated justifications; provide strategic technical leadership in control strategy discussions.
• Proactively identify analytical risks and define mitigation strategies.
• Develop approaches to address analytical questions from health authorities, including drafting, reviewing, and refining responses with subject matter experts.
• Act as change control owner for method updates and specification revisions.
• Build and maintain strong, collaborative relationships with key partners and stakeholders across the organization.

Benefits

• health, life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Manager