The Director of Cell Therapy Pilot Plant Operations in the Cell & Gene Therapy TRD organization
leads the Operations function for the delivery of clinical and non-clinical manufacturing. The role oversees multiple functions (incl. Production, Engineering, Logistics, and Tech Transfer) is responsible to shape and develop the strategic direction and drive operational excellence in line to support the portfolio and enterprise needs. The role serves as a strong partner for Research, Quality, and technical development line functions for organizational delivery and culture.
Your responsibilities will include, but are not limited to:
• Operate East Hanover Pilot Plant as a trusted, reliable source for early phase clinical trial cell therapy production enabling our pipeline and clinical trials.
• Assure that the facility, staff, and systems supports a flexible, compliant, multiproduct approach for TRD activities in addition to cGMP and non-GMP manufacturing.
• Instill and maintain a Quality culture and ensure cGMP compliance of all GMP operations.
• Assure that the facility is equipped with the technologies required to support both cGMP and non-GMP activities in process and analytical development, clinical manufacturing, process scale-up and testing. Oversee capital process and installation and readiness activities.
• Develop and maintain the appropriate Pilot Plant operational organization to effectively run pilot plant operations with the ability to balance changing priorities in development and GMP clinical demands.
• Coordinate with Global Clinical Supply for effective planning and delivery in a dynamic environment.
• In coordination with other functions (Procurement, Supply Chain, Quality, etc), develop and implement Materials Management systems to manage GMP raw materials, intermediates and clinical trial materials.
• Drive talent acquisition, training, retention, succession planning and professional development of all associates to fully unleash their potential
• Actively coach and develop direct reports
• Work closely with key stakeholders in Quality Control, Quality, Technical Development, NIBR, Technical Operations, etc. to enable projects to move rapidly and successfully into clinical manufacturing.
• In conjunction with appropriate Technical Development staff and project managers develop and manage manufacturing schedules.
• Responsible for the continuous improvement of all pilot plant operations.
• Work closely with the TRD, GDD, NIBR/TCO and all customers to develop accurate project budgets for all programs that enter the pilot operations.
• Assure that the facility budget is maintained, and costs are properly charged to the appropriate project activities.
• Provide fully executed tech transfer package and support from Phase 1/2 clinical operations to Phase 3 commercial facilities as projects progress through the development pipeline.
• Work closely with strategy to ensure appropriate manufacturing capacity is available for processes coming through the development pipeline.
• Management of the third-party service providers and corresponding contracts
• Ability to influence leaders at different organizational levels to achieve desired outcomes for the organization.
• Platform level thinking, ability to be a change agentWhat you’ll bring to the role:
• BS/MS in an Engineering or Scientific discipline or comparable experience, advanced degree desirable.
• 10+ years of experience in the operation of both non-clinical/ clinical manufacturing pilot plants. Operational experience at a senior level is necessary.
• Expertise in scale up and the validation of manufacturing processes is desired. Good understanding of the Technical research & development and tech transfers.
• Solid understanding of cGMPs as they apply to clinical manufacturing and testing activities .
• Previous people leadership experience preferably in an Operations organization
• Cell therapy experience preferred
The pay range for this position at commencement of employment is expected to be between $174,400 and $261,600/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?
236 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
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. Duties, responsibilities and activities may change at any time with or without notice.
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 +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.
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