For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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

The Director of Manufacturing is an exciting key role at the Oceanside CA site which is responsible for leading and developing a biologics team to successfully establish a high functioning and robust clinical and commercial operations producing viral vectors in a complex single use technology environment.  This role will instill a culture that achieves competitive commercial and clinical operational excellence with continuous improvement, operational efficiency, quality, and safety as its foundation.

This is a “hands-on” leadership role. The leader will be able to continue the build of three biologics operational units for upstream, downstream and fill finish/packaging.  The leader will collaborate with cross-functional teams of Facilities & Engineering, Supply Chain, MSAT (Manufacture Science & Technology), and Business Operations. The Director of Manufacturing will be knowledgeable and have had demonstrated experience to ensure compliance with Biological Single Use Technologies, Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), product licenses, Pivotal Clinical and Commercial Manufacturing, corporate policies and safety practices.

Responsibilities (include but are not limited to):

Leads manufacturing team with a focus on consistent and reliable biologics operations with high  success rates per batches and no to low deviations per batchesWorks hands-on to supervise and monitor performance of manufacturing manager and supervisor and the development of overall skills and expertise of the manufacturing teamAssures successful transfer of new biologic technologies/platforms and processesContinuous improvements in all operation processes including safetyInvestigates and resolve problems, identifying root causes, and proposes process improvements through clear communication utilizing expertise coupled with OE toolsEnsure operational readiness of team to perform and utilize single use technologies for upstream, downstream and fill finish platforms via training and preparation deliverablesEnsures manufacturing areas, team, and equipment meet all cGMP and regulatory specificationsManages manufacturing of products which closely impact budget line of the departmentCoordinates with Supply Chain on the creation and revision of production schedule based on Capacity Review Management and Operations Council Process.Ensures cGMP training and readiness of Manufacturing Team for compliance audits and day to day complianceCreates operational efficiencies related to materials, labor and overheadResolves organizational targets and interprets company policies for the departmentCreate an environment where productivity and efficiency are achieved and recognizedEstablish operational plans, goals and assignmentsAnticipate, prepare organization, and address inspection issues that impact plant operations.Maintain a high level of compliance through effective monitoring and reporting of operational, key quality and safety metrics while incorporating in 6S systemsEnsure timely execution of deviations, CAPA’s, change control support and continuous improvement initiativesManufacturing leader prepare team members for inspection activities, observation commitments, submission and agency requests for products for assigned manufacturing plantDevelop team’s technical capabilities for single use technologies, upstream and downstream manufacturing and fill/finish manufacturable activities for both pivotal clinical and commercial manufacturingProvide necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviewsCollaborate with cross functional leaders to implement strategy and shared goalsCommunicate, collaborate and interact with Manufacturing Leadership Team and functional department headsDevelop, administer, and execute to budgets, schedules, and goalsIndependently determine approach and requirements to managing teams and executing operations with meaningful collaborations with peer leadersOther duties as assigned

Basic Qualifications:

Doctorate and 8+ years of experience managing a cell culture and/or purification manufacturing team in the biotechnology or biologics industry ORMaster’s and 10+ years of experience managing a cell culture and/or purification manufacturing team in the biotechnology or biologics industry ORBachelor’s and 12+ years of experience managing a cell culture manufacturing and/or purification team in the biotechnology or biologics industry 

Preferred Qualifications:

Demonstrated ability to work side by side on the biologic floor or operations environment to develop a teamDeep understanding of the business, science, engineering, and technology of biotechnology, processes, equipment and facilitiesVery knowledgeable of the current regulations, Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's)Clinical (Pivotal-Phase II/III) and commercial cell culture and/or purification manufacturing experience highly preferredIn depth knowledge of process operations related to upstream and downstream equipment and ability to troubleshoot with facilities and the teamExpertise or knowledge in how Upstream bioreactors and Downstream TFDF/UFDF, Chromatography and Fill/Finish/Packaging Equipment operates.Expert knowledge of electronic quality systemsExcellent interpersonal, verbal and written communication skills are essential in this collaborative work environmentHigh energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstaclesWillingness to think outside of the box and adapt best practices to our small, but growing environmentAbility to adapt in a constantly evolving environmentAlways leading with safety area ownership utilizing 6 S and Gemba walks to establish a world class safety cultureSelf-motivated with a thorough sense of ownership in areas of responsibility

Does this sound like you? If so, apply today!

 

The salary range for this position is: $191,250.00 - $247,500.00. 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.
 

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.