Senior Manager, Technology Transfer
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:
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Kite is seeking a highly motivated individual to join the Technology Transfer team as a Senior Manager within Global Manufacturing Sciences & Technology group. In this role you will lead Tech Transfer projects for Kite's pipeline (pre-clinical and clinical) and/or commercial products portfolio (T-cell and vector products). You will provide strategic, technical leadership and project management expertise for end-to-end transfer of T-cell/ Vector Process and Analytical Methods. Primary responsibility will be to successfully drive technology transfer from Process Development to Clinical/ Commercial Manufacturing and between Clinical/ Commercial Manufacturing sites for cell therapy and vector products. Additionally you will lead project planning, facility fit/ gap assessments and authoring of Tech Transfer plans and reports.
Responsibilities (include but are not limited to):
- Lead Tech Transfer of Kite's Pipeline and/or Commercial products from Process Development to Clinical/ Commercial Manufacturing and between Clinical/ Commercial Manufacturing sites.
- Support Tech Transfer for all stages of product lifecycle, such as early phase pre-IND transfers.
- Lead project planning to closure and utilize Project Management methodologies
- Use experience in Process Development/ Manufacturing to provide resolution for Technical Challenges that may be encountered during Tech Transfer
- Lead cross-functional Tech Transfer teams, track project status, provide timely updates to leadership and perform risk identification and mitigation
- Author Tech Transfer Master Plans and Tech Transfer Summary Reports
- Develop/ Improve Technology Transfer business processes to enable right first time and efficient transfers
- Bachelor's +8 years of experience or Master's Degree +6 years in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or PhD +4 years of relevant experience.
- Strong knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics/ cell therapies.
- Working knowledge of Biologics Process development is essential. Cell therapy process development or manufacturing technical support experience is desired.
- Cell culture, aseptic processing and single use systems experience
- Experienced in Project Management and applying Project Management Methodology
- Experience leading or supporting tech transfers
- Knowledge of product lifecycle - Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturing
- Excellent presentation and communication skills
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development
- Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team based decisions
- Ability to think critically, and demonstrated troubleshooting and problem solving skills
- Ability to function efficiently and independently in a changing environment
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
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.