QC Specialist III

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

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.

 

The salary range for this position is: $107,185.00 - $138,710.00. 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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