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

We are looking for a Sr Director, Analytical Operations to join our team at our Kite headquarters in Santa Monica, CA.

Responsibilities include (but are not limited to):

Lead Analytical activities in support of engineered T cell products, including oversight of cross functional teamDesign, develop, execute and document analytical method development and qualification in support of process development, product release and stability, and product characterization of T cell therapies in Process DevelopmentIdentify, develop and implement appropriate analytical technologies and methods to study and characterize processes for production of T cell therapies, including process improvements and efficienciesLead and implement quality by design (QbD) and design of experiment (DOE) approaches to method development to quickly identify robust operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelinesLead analytical laboratory staff in the selection, design and implementation of novel analytical methods, including FACS/flow cytometry, with emphasis on automation and high throughput technologies
Manage method and analytical technology transfers to/ from contract testing labs and Kite facilities as appropriateLead the analytical arm of OOS investigations, deviations and CAPAsEnsure standard operating procedures, analytical test methods, analytical sampling plans, batch records, and monitoring, trending and improvement process for all Kite analytical methods meet the highest industry standardDraft and review of CMC sections and supporting documents for Regulatory filings. Participate in PAI, defend regulatory audits and draft responsesResponsible for personnel recruitment, development and retentionEnsure a collaborative work environment with key client groups in Research, Quality, Manufacturing and Process Development to support analytical method and process development as well as the characterization of Kite’s T cell products; e.g. lead maturation of research analytical methodology into Development and GMP, and analytical method technology transfer to and from Kite partners
 

Basic Qualifications:

Doctorate and 12+ years of biotech and/or pharmaceutical industry leadership experience ORMaster’s and 12+ years of biotech and/or pharmaceutical industry leadership experience ORBachelor’s and 14+ years of biotech and/or pharmaceutical industry leadership experience

Preferred qualifications:

Ph.D. in Chemistry, Biochemistry, Biology or related disciplineProven leadership ability in pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, analytical method development, technology transfer, and method qualification/validation and process developmentProven ability to work with both subordinate staff and corporate senior leadership teamExcellent interpersonal, verbal and written communication skillsAbility to lead a diverse, expert technical staff team with attention to detail, to think critically and demonstrate troubleshooting and problem solving skills, and work with and lead othersExpertise with analytical method development and qualification and analysis of cell therapy products
Well versed in various analytical techniques such as FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, enzyme assays and other applicable methods to the testing of biopharmaceuticals, preferred.Excellent understating of cellular processes and metabolism and experience working with human primary cells, including T cells, and flow cytometryKnowledge of QbD approaches to analytical method development including risk assessment, DOE, and statistical analysisStrong knowledge of technical writing for BLA, INDProficient in MS Word, Excel, Power Point and other applicationsAbility to function efficiently and independently in a changing environmentComfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

 

The salary range for this position is: $221,000.00 - $286,000.00. 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:

Kite Pharma 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.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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.

Kite Pharma 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.