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We’re 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. We’ve 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

+ Master’s Degree in Biochemical Engineering, Virology, Chemical Engineering, Biomedical Engineering or Biotechnology and 10+ years of related experience OR

+ Bachelor’s 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

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*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* 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 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 .

For jobs in the United States:

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 [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

Change The World With Us

Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.

We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.

While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.