Associate Director - Cell Therapy Analytical Project Lead

Job Description Summary

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

Skills Desired