Senior Expert/Associate Director, Analytical Project Lead

Job Description Summary

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 you'll 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 $114,100-$211,900/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.

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 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