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.

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 :

Preferred qualifications :

The salary range for this position is : $205,615.00 - $266,090.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance 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 system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

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