Hiring company: Kite Pharma
Kite is seeking a highly motivated leader with viral vector process development and T Cell experience to lead a team working on innovative cell therapies for cancer treatment. The Senior Director will provide vector process development and related CMC leadership for development of new vectors, technical support, and process improvements for Kite’s engineered T cell therapy products. The Senior Director will lead and accountable for vector process development and GMP Phase I to III manufacturing protocols, as well as establishing production procedures. This position will lead a team of scientists and technical specialists responsible for vector process development and characterization and provide technical oversight to GMP manufacturing internally and at CMOs. The incumbent will interact cross-functionally to support successful vector and T cell process development, process characterization and commercialization of Kite’s autologous and allogeneic T cell products.
Responsibilities include, but are not limited to:
- Create process development programs for manufacturing of viral vector for development of Cell Therapy products.
- Manage vector process development and ensure timely progression of projects.
- Assist in developing budget projections, material and staffing forecasts.
- Demonstrate managerial skills and a strong working knowledge of the regulatory compliance requirements for the production of biologicals for clinical stage and commercial use.
- Participate in hiring, training, supervising and evaluating staff.
- Manage a Process Development lab related to vector process, and GMP Phase I Vector Manufacturing Facility.
- Ensure close cooperation with MSAT to troubleshoot any vector processes that have been transferred to Manufacturing.
- Manage cross-functional teams to advance pipeline development and provide technical guidance for production activities.
- Drive process improvements and efficiencies across different stages of development and clinical/commercial manufacturing.
- Ensure sound design and process characterization studies to develop a thorough understanding of late stage Manufacturing process to support success transfer and launch of new products.
Requirements:
- PhD in Biochemical Engineering, Biotechnology or Life Sciences with 8+ years of biopharmaceutical manufacturing, technology transfer or process development experience
- Masters’ Degree in Biochemical Engineering, Biotechnology or Life Sciences with 10+ years of biopharmaceutical manufacturing, technology transfer or process development experience
- Bachelors’ Degree in Biochemical Engineering, Biotechnology or Life Sciences with 12+ years of biopharmaceutical manufacturing, technology transfer or process development experience
Additional Qualifications
- Experience in vector process development (RVV, LVV, AAV, etc) or manufacturing
- Background in cell therapy, mammalian cell culture and purification systems
- Expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
- Practical experience in GMP operations
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development
- Ability to think critically, and demonstrated troubleshooting and problem-solving skills
- Excellent interpersonal, verbal and written communication skills
- Ability to function efficiently and independently in a changing environment
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Well-developed computer skills
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.