QC Specialist III

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

This position is for Sun-Wed Swing Shift 12:00PM to 10:30PM.

Primary Job Responsibilities:

Lead (or support) projects in Analytical Method development

validation and method technology transfer in areas of Flow Cytometry

ddPCR and Bioassays consisting of cell culture and ELISA.

Lead (or support) studies implementation of new processes or

technologies and revise or review SOPs qualification/validation

protocols and reports.

Perform analytical assays in techniques such as Flow cytometry

ddPCR cell culture and ELISA GMP environment.

Maintain calibrate and operate equipment and instruments supporting

cell bioassays Flow Cytometry ELISA and PCR assays.

Support audit activities and regulatory inspections by assisting in

preparation of dossiers and data packages for interactions between

Kite and Regulatory agencies if needed.

Review proposed changes to systems procedures methods and

submissions to regulatory agencies as appropriate.

Lead investigations regarding out of specification (OOS) results

Out of Trend (OOT) events and any other unexpected event related to

the laboratory.

Support generation of trending charts for monitoring method

performance product quality invalid rate and/or stability.

Perform QC sample receipt processing and distribution for testing

and storage as well as track inventory of lab supplies and materials.

Monitor the GMP systems currently in place to ensure compliance with

documented policies

Support generation of CoAs for product release as needed.

Mentor and support on the job training for junior staff.

Specific Education & Experience Requirements:
5 years of relevant experience and a BS or BA.
3 years of relevant experience and a MS.
Prior experience in pharmaceutical industry is preferred.

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.