Senior Expert/Associate Director, Analytical Project Lead

East Hanover, NJ - USA

Monthly Salary: $ 114100 - 211900

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Description Summary

Position is located in East Hanover NJ
LI #hybrid

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 Senior Expert or Associate Director to join our Analytical Project Leads team as an Analytical Project 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 Analytical Project Lead you will be instrumental in developing and driving analytical strategies ensuring seamless execution and managing cross-functional communication across Cell Therapy programs from Inception to commercialization.

Job Description

Key Responsibilities:

Develop and oversee end-to-end analytical strategies for the assigned Cell Therapy Program(s) including analytical method development validation transfer product characterization and CQA assessment specification and release etc.
Represent Cell Therapy Analytical function in program CMC meetings providing updates and sharing key takeaways. Act as a liaison between Analytical Development Analytical Operations Technical Operations and the Regulatory CMC team to streamline execution of analytical deliverables.
Regularly prepare and deliver program updates to various stakeholders.
Assess resources and budget needs for program key milestones including process/product characterization method externalization and internal resource allocation. Manage scope timelines and budget activities with external analytical laboratories.

Provide technical expertise and leadership as you collaborate within and across cross-functional teams to support process development and establish control strategy.

Provide strategic recommendations across the network.

Develop strategies to address analytical-related questions from health authorities which include drafting reviewing and revising responses prepared by subject matter experts.
Serve as the change control owner for method updates and specification revisions.
Build and maintain robust relationships with key partners and stakeholders.

What youll bring to the role:

This is a dual posting. The final level & title of the offer role would be determined by the hiring team based on the skills experience & capabilities required to perform the role at the level the role has been offered (Senior Expert/Associate Director):
Essential:
For Senior Expert level BS with 8 years in relevant field MS with 6 years or Ph.D. with 4 years of analytical experience in biotechnology/pharmaceutical industry.
For Associate Director level BS with 12 years in relevant field MS with 8 years or Ph.D. with 6 years of analytical experience in biotechnology/pharmaceutical industry.
Proven track record in late phase development commercialization and life cycle management of biologic/cell therapy products.
A critical thinking mindset problem-solving skills and interpersonal communication scientific writing and presentation abilities to provide effective leadership.
Strong organizational skills and ability to prioritize simultaneous projects and activities.
Passion for continuous learning and capability to work in a highly dynamic fast-paced collaborative environment is key to the success of this role.

Desirable:
Cell Therapy experience is highly desired; Biologics experience is also considered.

Experience with analytical support for biologic product commercialization especially in cell/gene therapy field.
Hands-on interest and experience in relevant analytical methods.
Experience in regulatory filing and addressing health authority questions and other correspondence/interactions with regulatory agencies
Program management experience.
Familiarity with GMP practices requirements and regulations (FDA/EMA/ICH etc.)

The salary for this position is expected to range between $114100-$211900/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 addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

To learn more about the culture rewards and benefits we offer our people click here.

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 or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$114100.00 - $211900.00

Skills Desired

Coaching Skills Data Science Environment Experiments Design Health And Safety (Ehs) Laboratory Equipment Manufacturing Process Materials Science Process Simulation Sop (Standard Operating Procedure) Technical Writing Waterfall Model

Required Experience:

Director

Job Description SummaryPosition is located in East Hanover NJ LI #hybridPioneering New Frontiers: At Novartis our mission in Cell Therapy Analytical Development and Operations is to innovate for patient benefit. We are seeking an inspiring Senior Expert or Associate Director to join our Analytical P...