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- Establish and maintain standards of work, business processes and platform strategy. Strategize and oversee critical quality attributes assessments, control strategies, and comparability criteria setting for diverse products.
- Ensure seamlessly analytical strategy execution for all cell therapy products. Manage the timely development, qualification, and transfer of methods for GMP lot release and stability studies.
- Author and refine regulatory CMC packages, including analytical methods and specifications for IND and BLA filings. Develop strategies for addressing health authority inquiries.
- Innovate with next-generation analytical methods to expedite the release of T-ChargeTM products.
- Offer strategic insights across the analytical network, encompassing Cell Therapy, Gene Therapy and Biologics.
- Build and maintain robust relationships with key partners and stakeholders such as TO, NIBR, GDD, Quality and RA CMC.
- BS with 15+ years, MS with 12+ years, or Ph.
- A minimum of 5 years of leadership skills, encompassing both direct and matrix management.
- Proven track record in late phase development, commercialization, and life cycle management of biologic/cell therapy products.
- Extensive experience in regulatory filing and addressing health authority questions.
- Exceptional communications, scientific writing, and presentation skills.
- Hands-on interest and experience in relevant analytical methods.
- Strong foundation and practical experience in statistics.
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Director Analytical Project Lead - East Hanover, United States - Novartis
Description
Director Analytical Project LeadJob ID
392112BR
Feb 13, 2024
USA
About the Role
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 Director to lead our team of Analytical Projects Leads.
In this critical role, you will orchestrate the Analytical CMC strategies for various stages of cell therapy products, significantly contributing to the development and commercialization of groundbreaking CAR-T therapies.
Your Impact:
As the Director, you will helm the Cell Therapy Analytical Project Lead function, driving excellence in a team renowned for agility and high performance.
You will be instrumental in shaping our analytical landscape, setting standards, and guiding our product portfolio's analytical strategies from inception to commercialization.
Your responsibilities will include, but are not limited to: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:
[email protected]
or call
Sandoz:
[email protected]
or call:
Role Requirements
What you'll bring to the role:
Desirable Capabilities:
The pay range for this position at commencement of employment is expected to be between $192,000 and $288,000/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 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.
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 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?
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:
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
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