Commercial Stability Lead
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job
Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!
We are seeking a highly motivated individual to join us as a Commercial Stability Lead who will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy and report to the Director of Product Quality.
The Commercial Stability Lead will run product, process material and critical starting material stability programs for Kite's commercial products. This position will be located at Kite's corporate headquarters in Santa Monica, CA.
Responsibilities (include but are not limited to):
- Provide leadership for stability programs for commercial products.
- Assist in the development of the overall stability strategy for Kite products.
- Accountable for stability data monitoring and reporting, including development of trending requirements.
- Work with Product Quality, Operations Teams, and Regulatory Affairs to ensure stability programs are aligned with the product strategy.
- Author stability sections of regulatory filing documents and support responses to health authority questions relative to stability programs.
- Support inspections and audits by serving as stability program expert.
- Develop, track, and communicate stability program metrics to management
- Identify and escalate Stability program compliance gaps or issues.
- Ensure Stability program conformance to regulations, health authority expectations, industry standards and quality policies.
- Bachelor's degree in life sciences, engineering, statistics or related discipline with a minimum of 8 years of experience OR Master's degree in life sciences, engineering, statistics or related discipline with a minimum of 6 years of experience of combined Quality and technical experience in a GMP field within a biotechnology, biologics, or pharmaceutical company.
- Minimum of 2 years of experience with stability programs and writing technical and regulatory documents for a late stage clinical or commercial product.
- Expertise in data analysis, trending, and reporting
- SQL programming experience is preferred
- Experience with deviations, CAPAs and change controls is preferred
- Strong knowledge of stability program regulatory expectations (e.g., ICH) and cGMPs.
- Excellent customer focus, enabling strong collaboration with various department system owners and functional area managers
- Ability to communicate and work independently with scientific/technical personnel.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Must be able to work on multiple projects simultaneously and demonstrate ability to organize, prioritize and manage time
- Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities.
- Advanced Skills with MS Office applications Word, Excel and Access, as well as Adobe Acrobat and various statistical tools (e.g., JMP).
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
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For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.