Assoc. Director Science & Technology-Molecular Analytical Development

Assoc. Director Science & Technology-Molecular Analytical Development

Job ID

Mar 19, 2024

USA

About the Role

Join us in Transforming Cell Therapy: Novartis Cell Therapies is at the forefront of delivering groundbreaking CAR-T therapies to patients in need. We are actively seeking an Associate Director to shape analytical strategies for late-phase cell therapy programs. This pivotal role is instrumental in driving the success of our programs, from pivotal trials to the delivery of effective CAR-T therapy.

Your impact: As the Associate Director, you will be an integral part of our Analytical Development team, collaborating closely with cross-functional partners, including Novartis Operations, and Regulatory CMC. Your contribution will directly impact our mission to provide innovative therapies to patients with life-threatening diseases.

Your responsibilities will include, but are note limited to:

• Serve as Subject Method Expert to facilitate the development, validation, transfer, and trending of molecular based Cell therapy analytical methods, including qPCR/dPCR, binding assays, and molecular based sterility testing. The primary objective is to ensure the robustness of these methods, enabling Quality Control (QC) to expedite product release. Additionally, ensure that the method package meets all regulatory health authority requirements.

• Shape strategies for cell therapy product characterization using various molecular-based analytical methods.

• Develop and drive strategies for analytical method changes, assessing their impact on existing processes, stability, specification, and regulatory filing. Design bridging studies and implementation plans.

• Author, review and approve technical documents and procedures related to methods.

• Contribute to regulatory CMC packages for IND and BLA filings, shaping strategies for addressing health authority inquiries.

• Provide strategic recommendations across analytical network, spanning Cell Therapy, Gene Therapy and Biologics.

• Offer technical and strategic input to cross-functional program teams to inform critical development decisions.

• Cultivate and maintain strong internal partnerships with colleagues including Process Development, Quality, Operations and Regulatory CMC.

Diversity & Inclusion / EEO

We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

• Novartis: e-mail [email protected] or call +1 [Register to View]
• Sandoz: e-mail [email protected] or call: +1-[Register to View]

Role Requirements

What you'll bring to the role:

• BS with 12+ years, MS with 8+ years, Ph.D. with 6+ years of analytical experience in biotechnology/pharmaceutical industry.

• Extensive experience with developing and optimizing molecular based analytical methods for cell therapy product release and characterization.

• Proven experience in late-stage analytical CMC development and product commercialization in the Cell Therapy field.

• Extensive familiarity with regulatory filing and ability to respond effectively to health authority questions regarding analytical methods and product specifications.

• Exceptional communication, scientific writing, and presentation skills.

Desirable Requirements:

• Knowledge and practical experience in statistics.

• Experience in Quality Control.

The pay range for this position at commencement of employment is expected to be between $166,400 and $249,600 year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Why Novartis?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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 in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 [Register to View] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Division

Development

Business Unit

TECHNICAL R & D GDD

Location

USA

Site

East Hanover, NJ

Company / Legal Entity

Novartis Pharmaceuticals

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

No