Associate Director Cell Therapy Analytical Project Lead

Job Description Summary Position:

Associate Director -

Cell Therapy Analytical Project Lead Location:

East Hanover, NJ #onsite Novartis will not sponsor visas for this position. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you

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 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.

Job Description Key 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.

Job 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. The salary for this position is expected to range between $145,600 and $270,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $145,600.00 - $270,400.00 Skills Desired Budget Management, Coaching Skills, Data Science, Experiments Design, Laboratory, Problem Solving Skills, Process Simulation, R D, Waterfall Model Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people's lives. Novartis is aware of employment scams which make false use of our company name or leader's names or recruiter's names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .