Quality Control Specialist III- Analytical
United States - California - OceansideQualityRegularDescripción del trabajo
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 professional reporting to the Sr. Manager of Quality Control, Analytical. You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.
Responsibilities:
Support assay implementation to assess T cell function and viral vectors using Flow Cytometry, PCR and Cell based assays.
Successfully implement and document laboratory procedures and experiments with great attention to detail.
Contribute a dynamic, exciting culture that embraces teamwork and passion.
Become SME and trainer on laboratory procedures including ddPCR, qPCR, Flow and ELISA.
Own and manage Quality record (CAPA, Deviation, LIR).
Compile and reviews data and support process trending procedural updates and other documents.
Provides technical support for validation protocols implementation.
Supports the Quality control analytical department by identifying or troubleshooting issues that may affect laboratory or facility monitoring systems or processes and other support to daily QC operations.
Implements protocols for the qualification and re-qualification of new and current instrumentation.
Validates required improvements to methods.
Performs method and equipment validation and training.
Conduct investigations regarding out of specifications (OOS) results, address and manage deviations/CAPAs related to analytical procedures.
Supports the Quality control analytical department by identifying or troubleshooting issues that may affect laboratory or facility monitoring systems or processes and other support to daily QC operations.
Organize and implement multiple projects in collaborative team environment.
Proposes, implements, and qualifies current and new pharmacopoeia methods to improve processes and/or ensure compliance with GMP’s and other regulatory requirements.
Complete routine record review of test data and related documents for in-process and routine environmental monitoring testing, drug product release.
Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
Manage reagents, data and inventory in lab and Kite Information Management Systems.
Basic Qualifications:
Master’s and 3+ years of Pharma experience OR
Bachelor’s and 5+ years of Pharma experience OR
Associate and 7+ years of Pharma experience OR
High School Diploma/GED and 9+ years of Pharma experience
Preferred Qualifications:
10 years of experience in Quality Control analytical.
Excellent background in Analytical testing and sound knowledge of Flow Cytometry, ELISA, ddPCR scientific principles.
Experienced in cell and gene therapy.
Excellent working knowledge of GMP.
Experience in validating various QC analytical methods.
Comfortable in exciting small company environment with minimal direction and able to adjust workload based upon changing priorities.
Does this sound like you? If so, apply today!
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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.