Quality Control Specialist III- Microbiology
United States - California - OceansideQualityRegularОписание вакансии
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 Manager of Quality Control Microbiology. You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.
Responsibilities:
Lead the development and refinement of methodologies for microbiological testing, etc.
Develop, write, implement, review qualification/validation protocols and reports.
Project lead (or support) in Tech Transfer, and lead validation of microbiological methods and automation in QC.
Lead the implementation Method Suitability Testing (MST) protocols for Microbiology assays.
Lead, develop, and implement multiple simultaneous projects that are complex and technically demanding through significant interactions with internal staff and external experts.
Draft laboratory investigations, deviations, CAPAs and support troubleshooting associated with QC Microbiology responsibilities identified through GMP manufacturing and QC support processes.
Monitor the GMP systems currently in place to ensure compliance with documented policies.
Lead teams to support deviations, investigations, CAPAs and change control activities and Laboratory Investigations/OOS.
Manage global change controls and annual report data from QC Microbiology.
Assist in establishing user requirements for purchase and qualification of Kite’s QC microbiology equipment and materials/reagents.
Implements protocols for the qualification and re-qualification of new and current instrumentation, and review qualification/validation protocols and reports.
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.
Identify and lead teams for lean improvement activities.
Up to 10% domestic travel
Additional duties as assigned.
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:
Experienced in cell and gene therapy.
10 years of experience in Quality Control Microbiology.
Excellent background in microbiological testing and sound knowledge of sterility, bioburden, and endotoxin testing’s scientific principles.
Excellent working knowledge of GMP.
Experience in validating various QC Microbiology methods.
Comfortable in a 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.