QC Specialist II

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 were 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

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the worlds most devastating diseases united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

We are seeking a highly motivated individual to join us as a Quality Control Specialist II reporting to the QC Analytical Sr Manager. You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.

As a QC Specialist II at Gilead/Kite you will ...

Key responsibilities

• Execute the transfer and validation of analytical methods to Oceanside CA QC.

• Provide Training on Analytical methods.

• Perform drug substance lot release and in-process testing and stability using PCR cell-based assays and/or flow cytometry (multiple colors preferred) in a GMP environment.

• Provide support for assay performance and troubleshooting of analytical issues in the context of a GMP laboratory.
• Experience using LIMS lab information management System.

• Support deviations investigations CAPAs and change control activities and Laboratory Investigations/OOS.

• Assist in establishing user requirements for purchase and qualification of Kites QC analytical equipment and materials/reagents.

• Work with internal and external resources to maintain equipment in an optimal state.

• Develop revise and review SOPs test methods and work instructions.

• Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies.

• Support and participate in regulatory agency inspections.

• Assist with daily sample and reagent management activities such as receipt aliquoting organization inventory control and maintaining traceability in accordance with GMP/GDP expectations
• Identify and lead teams for lean improvement activities.

• Up to 10% domestic travel

• Capability to lift and move items weighing up to 50 lbs on an occasional basis.

• Additional duties as assigned.

Basic Qualifications:

• Masters Degree and 4 years pharmaceutical experience OR

• Bachelors Degree and 6 years pharmaceutical experience

Preferred Qualifications

• Experienced in cell and gene therapy.

• Strong working knowledge of GMP.

• Strong background in Flow Cytometry testing and sound knowledge of Flow Cytometry scientific principles.

• Strong background and knowledge in Droplet Digital PCR testing.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

For additional benefits information visit:

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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at 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 disabilitygenetic 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 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 for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

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Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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.