Sr. Product Steward

Band

Level 5

 

Job Description Summary

This position will be located at Morris Plains, NJ and will not have the ability to be located remotely.

The Sr. Product Steward is responsible for participation as part of a team for the technical leadership of an assigned product. The product may be manufactured by Novartis Technical Operations or by a 3rd party CMO. Responsibilities may also include management and technical leadership of other Product Stewards assigned to different products.

Key Responsibilities:
• Responsible for strategic decisions with cell and gene therapy leadership to ensure compliance and consistent supply to all registered markets.
• Participates in driving strategies around cost efficiencies of production while minimizing risks and driving reduction in technical product risks.
• Responsible for escalating issues to functional leadership and proposing tradeoffs and risks.
• Single point of contact for the robust timely high quality supply and crisis management for product franchise impacting issues.
• Provide leadership and technical guidance to process stewards on critical issues.
• Responsible for the technical life-cycle management and participation in regulatory filing review.
• Responsible for tracking and resolution of post-marketing commitments.
• Coordinate and assess impact of changes to commercial supply chain and regulatory functions.
• Technical stewardship and lifecycle management includes drug substance and drug product manufacturing, as well as labeling/packaging, and supply chain distribution, from initial license approval until retirement of the product.
• Technical review/approval of regulatory documents (e.g. Market expansion and variations). Resolution of information requests and market specific commitments.
• Responsible for review and approval of final APQR.
• Product Quality Impact Assessments for ex-US supply owned by Novartis.
• Works with 3rd party counterpart for establishing cross-company meeting agenda topics, collaboration benchmarks, market submission timelines, etc.

 

Job Description

• M.S. degree in biochemistry, chemical engineering, bioengineering, or a related technical field, with at least 10 years of experience in biopharmaceutical manufacturing; or a B.S. degree with 12 years of experience.
• Master’s degree or PhD preferred.
• Excellent oral and written communication skills.
• Experience in PAI and GMP regulatory audit defense.
• Familiarity with global regulations for devices, drugs, and validation/qualification requirements.
• Strong organizational skills and attention to detail.
• Proven ability to lead and participate effectively in teams.
• Ability to multitask across multiple projects, and activities.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $152,600 and $283,400/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period.  Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. 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.

Company will not sponsor visas for this position.

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

 

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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people