Assoc Director Science & Technology - Flow & Potency
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 not limited to:
* Serve as Subject Method Expert to facilitate the development, validation, transfer, and trending of Cell therapy flow cytometry and potency analytical methods. The primary objective is to ensure the robustness of these methods and that the method package meets all regulatory health authority requirements.
* Shape strategies for cell therapy product characterization using various flow cytometry and potency analytical platforms. Offer forward thinking technical insights to development teams, identifying new platforms and technologies.
* 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. EEO Statement 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 us.reasonableaccommodations@novartis.com or call +1 (877)395-2339
- Sandoz: e-mail reasonable.accommodations@sandoz.com or call: +1-609-422-4098
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 flow cytometry and potency 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.
Preferred Capabilities:
* 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?
799 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
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 tas.nacomms@novartis.com 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. Business Unit TECHNICAL R & D GDD Work Location East Hanover, NJ Company/Legal Entity Novartis Pharmaceuticals Functional Area Research & Development
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Novartis Group Companies
parental leave, paid time off, sick time, 401(k)
April 15, 2024