Quality Control Specialist III

职位描述

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

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?

We are seeking a highly motivated individual to join us as a Quality Control Specialist III reporting to the Head of Quality Control Technical Services. You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.

Responsibilities:

• Implement GMP testing and method qualification/validation using flow cytometry, droplet digital PCR, and ELISA-based methods.
• Author qualification/validation protocols and reports.
• Qualify critical reagents.
• Perform data analysis for validation/qualification activities using Excel.
• Lead method monitoring activities.

• Author Standard Operating Procedures (SOP) and test material specifications.
• Manage site and global quality documents.

Additional job duties include:

• Mange deviations, CAPAs, investigations, and change controls.
• Support routine GMP testing activities.
• Implement worksheet validations.
• Coordinate with Quality Control LIMS Administrator to support quality metrics.
• Partner with Supply Chain to manage reagent cost and usage.
• Lead On the Job Training of Analytical Methods

Basic Qualifications:

• Master’s Degree and 3+ years’ pharmaceutical experience OR
• Bachelor’s Degree and 5+ years’ pharmaceutical experience

Preferred Qualifications

• Experienced in cell and gene therapy.
• Thorough working knowledge of GMP.
• Experienced in Droplet Digital PCR and Flow Cytometry.
• Comfortable in a exciting small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Background in regulatory guidances (e.g., ICH, USP, EP, JP)

Does this sound like you? If so, apply today

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The salary range for this position is: $104,805.00 - $135,630.00. 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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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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.

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For Current Kite Pharma Employees and Contractors:

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