Sr. Manager, Stability, Material, and Quality System Management, Cell and Gene Therapy Analytical Operations

Key Responsibilities:

• Lead and manage a team of Quality Control associates in performing routine raw material inspection and supporting raw material specifications, including justification of specifications for Novartis Cell and Gene products in the clinical stages.  
• Oversee various stability studies (long terms, accelerated, stressed) on Drug Substance, Drug Product or Final Product for Cell and Gene therapies, both internally and externally.  
• Coordinate shift work, activities and priorities to meet the required business timelines, serving as the primary point of contact for communication with management.
• Develop strategies for trending stability data and monitoring stability trends for all studies related to viral vectors or finished products in real time.
• Design and lead comprehensive studies related to raw materials and stability, ensuring scientific rigor and regulatory compliance. Influence internal stake holders and justify approaches to drive alignment. Respond efficiently and effectively to Health Authority queries regarding these areas.
• Organize, plan, and support team members with technical questions, ensuring group’s efficiency and accountability. Mentor and coach team members, facilitating their career growth and professional development.
• Ensure that all activities, follow current Good Manufacturing Practices, and Health, Safety, and Environmental policies per the global/local Novartis standards.
• Lead and perform Out-of-Specification (OOS)/Our-of-Expectation (OOE) investigations. Manage change controls, deviations, and CAPA implementation.
• Support laboratory inspections and audits, including follow-up actions to address any findings.
• Foster clear and precise communication within the team and across departments to ensure transparency, collaboration, and efficiency.
• Plan and manage resources and budget including Capital Expenditure (CapEx).

Requirements:

• BS with a minimum of 6 years of industry experience in Stability and/or Material management in biotech or pharmaceutical companies, including at least 2 years of direct people management experience in a Quality Control environment.
• Extensive knowledge and experience in material management and stability programs for Cell and Gene or Biological products.
• Extensive experience working in a GMP environment.
• Familiarity with ICH and agency guidelines related to raw materials and stability for Cell and Gene Therapies.
• Strong communication, scientific writing, and presentation skills.

Desirable Requirements:

• Experience in resource and budget management.
• Experience with electronic systems such as SAP, LIMS, and Quality Management Systems.

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? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: The Novartis Group of Companies 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.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $112,000-$169,200/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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.

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