Director, Viral Vector Process Design

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Job Description

Kite is recruiting a highly experienced and strategic Director in our Viral Vector Process Design (PDe) organization based in Santa Monica CA. This individual will be an integral leader of process development for the viral vector programs at Kite with a dedicated focus on upstream process development and scale-up of Lentiviral Manufacturing processes. The role also requires a strong emphasis on viral safety and regulatory compliance. The successful candidate will bring deep technical expertise and leadership in Lentiviral Vector (LVV) production for ex-vivo and in-vivo applications with a proven track record of advancing candidates from research through IND-enabling studies as well as commercialization.

In addition this individual will drive robustness innovation and compliance across LVV process development workflows and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a highly collaborative environment partnering closely with Research Analytics CMC Regulatory Commercial Manufacturing Quality and external partners.

In addition this individual will drive robustness innovation and compliance across LVV process development workflows and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a highly collaborative environment partnering closely with Research Analytics CMC Regulatory Commercial Manufacturing Quality and external partners.

Responsibilitiesinclude but are not limited to:

• Develop manufacturing processes for Viral Vector products and develop process improvements and efficiencies
• Lead and develop a high-performing Viral Vector Upstream process design team comprised of senior and junior level staff; collaborate cross-functionally within Viral Vector PDe organization as well as being a key player in interactions with stakeholders and partner organizations
• Lead and oversee design planning and execution of laboratory studies to support cutting edge Viral Vector processand process platform designanddevelopment
• Develop and execute Viral Vector process characterization studiesto develop a thorough understanding of operating and performance parameters; Implement and maintain a state-of-the art knowledge management system
• Foster the growth and development of Viral Vector process design staff including hands-on training if needed
• Guide the execution of Viral Vector process development characterization and phase-appropriate validation activities as well as transfer of processes to manufacturing facilities
• Provide technical expertise and strategic leadership within project teams and in a matrix environment with a focus on upstream process development for LVV
• Provide Viral Safety subject matter expertise as needed to ensure robust viral safety testing strategies are implemented across all viral vector processes including stringent adventitious virus testing plans that align with regulatory requirements and guidelines. Additionally provide technical expertise to risk assessments and mitigation plans to address potential viral safety concerns throughout process development and manufacturing
• Leads a team that generates technicaldocumentation including but not limited to study protocols process development and validation reports and process/manufacturing sections of regulatory documents
• Draft Viral Vector process development timeline scenarios and develop resource projections to enable pipeline project execution and inform portfolio decisions including risk assessments mitigation plans lessons learned standard methodologies
• Participate and influence a cross-functional development team to advance production activities
• Perform Viral Vector process analysis and trend process performance
• Build and maintain a collaborative culture with key partners (site and global) and customers including Research Manufacturing and Quality
• In collaboration with other functions implement and maintain fit-for-purpose effective systems and business processes to assure compliance to corporate guidelines
• Oversee or serve on cross functional teams as needed.

Education and Experience:

• Advanced scientific degree (i.e. MD PharmD PhD) inin Biochemical Engineering Virology ChemicalEngineeringBiomedical EngineeringBiotechnologyand 8 years of related experience OR
• Masters Degreein Biochemical Engineering Virology ChemicalEngineeringBiomedical Engineering orBiotechnologyand10 years of related experienceOR
• Bachelors Degreein Biochemical Engineering Virology ChemicalEngineeringBiomedical Engineering orBiotechnologyand12 years of related experience

Preferred Qualifications:

• Demonstrated previous experience and excellence in Lentiviral Vector process development with a focus on Upstream Process Development used for Cell/Gene Therapies process technology transfer scale translation and statistical DOE (design of experiments)
• Proven leadership in viral safety assessments
• Experience scaling Lentiviral Vector processes to clinical/commercial manufacturing scales
• Excellent communication and presentation skills and aptitude for problem solving
• Experience with the preparation of regulatory filings for US and external markets
• Understanding of GMP manufacturing
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products LVV processing technologies cell therapy and gene therapy products and process development execution
• Practical demonstration of hands-on process development including use of statistical design
• Comprehensive expertise in biosafety testing principles viral clearance studies and virus risk mitigation strategies specific to viral vector manufacturing processes
• Deep understanding of regulatory guidelines and industry best practices related to adventitious virus testing and viral safety control
• Practical experience of cGMP manufacturing operations and fluency of regulatory regulations
• Experience with automation technologies
• Ability to think critically and demonstrate troubleshooting and problem-solving skills
• Ability to lead and manage teams including track record of coaching and mentoring talent
• Excellent interpersonal verbal and written communication skills
• Ability to function efficiently and independently in a constantly evolving environment.
• Self-motivated with a strong sense of ownership and willingness to accept temporary responsibilities
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload
• Demonstrate ability to work and collaborate in cross functional and matrixed teams
• Experience driving and motivating teams to meet aggressive timelines and deliverables
• High energy level and a positive outlook with can do attitude to achieve goals and overcome obstacles
• Ability to travel based on business priorities

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

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