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Director, Viral Vector Process Design

United States - California - Santa Monica Process/Product Development & Operations Regular

Job Description

Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

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.

Responsibilities include, 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 process and process platform design and development,
• Develop and execute Viral Vector process characterization studies to 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 technical documentation, 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) in in Biochemical Engineering, Virology, Chemical Engineering, Biomedical Engineering, Biotechnology and 8+ years of related experience OR
• Masters Degree in Biochemical Engineering, Virology, Chemical Engineering, Biomedical Engineering or Biotechnology and 10+ years of related experience OR
• Bachelors Degree in Biochemical Engineering, Virology, Chemical Engineering, Biomedical Engineering or Biotechnology and 12+ 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

Job Description

Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

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.

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