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QC Operations Specialist I

Job Overview

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Employment Type

Full-time
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Compensation

Salary
Range $80,325.00 - $103,950.00
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Benefits

Health Insurance
Dental Insurance
Vision Insurance
Life insurance
Paid Time Off
discretionary bonus
Stock-based incentives

Job Description

Kite Pharma is a leading biopharmaceutical company dedicated to developing innovative cancer immunotherapies, with a primary focus on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies. These therapies are designed to empower the immune system’s ability to recognize and destroy tumors, providing rapid, long-term durable responses and aiming to eliminate the burden of chronic care for cancer patients. Headquartered in Santa Monica, California, Kite operates at the forefront of personalized medicine and has made revolutionary scientific breakthroughs that have transformed the paradigm of cancer treatment. As part of the Gilead Sciences family, Kite benefits from significant resources, research capabilities, and a commitment to improving patient outcomes worldwide. The company fosters an inclusive work environment that values diversity, innovation, and the development of every employee. Kite’s mission is clear: to cure cancer by relentlessly advancing treatment options and improving the lives of patients affected by this devastating disease.

The Quality Control Operations Specialist I position at Kite is an exciting opportunity for highly motivated individuals looking to contribute to this groundbreaking work in a critical support role. Reporting to the QC Analytical Senior Manager, the specialist will be involved in performing essential drug substance lot release testing, in-process and stability testing in a Good Manufacturing Practices (GMP) environment. This role leverages cutting-edge technologies such as PCR, cell-based assays, flow cytometry, and viral vector stability testing. The position demands meticulous attention to detail, disciplined documentation practices, and the ability to adhere strictly to regulatory requirements and company standards.

The specialist will also support routine laboratory analytical testing, proficiency in navigating the Kite Laboratory Information Management System (KLIMS), and management of various sample handling tasks, including aliquoting, shipping, and maintaining sample integrity and traceability. Furthermore, the role involves managing inventory, conducting laboratory maintenance, preparing media, ordering reagents, and ensuring the lab environment and equipment meet all safety and compliance standards. Individuals in this role will contribute to the execution of validation and verification protocols, assist with quality system adherence such as deviations and corrective actions, and participate in training activities.

This position offers a salary range between $80,325 and $103,950, considering experience, qualifications, and geographic location, with the potential for discretionary bonuses and stock-based incentives. Additional benefits include comprehensive medical, dental, vision, and life insurance plans. Kite emphasizes creating a supportive environment where leaders foster inclusion, development, and empowerment, making this role ideal for professionals eager to make a tangible difference in cancer therapy development while growing their career within a collaborative and innovative company.

Job Requirements

  • Bachelor’s degree in a scientific discipline such as biology, chemistry, biochemistry or related field
  • Experience working in a GMP or regulated laboratory environment
  • Knowledge of molecular biology techniques such as PCR and cell-based assays
  • Familiarity with flow cytometry and viral vector testing
  • Strong attention to detail and ability to maintain accurate records
  • Proficiency with Laboratory Information Management Systems such as KLIMS
  • Ability to lift and move items weighing up to 50 lbs on an occasional basis

Job Qualifications

  • Bachelor’s degree in a scientific discipline such as biology, chemistry, biochemistry or related field
  • Experience working in a GMP or regulated laboratory environment
  • Knowledge of molecular biology techniques such as PCR and cell-based assays
  • Familiarity with flow cytometry and viral vector testing
  • Strong attention to detail and ability to maintain accurate records
  • Proficiency with Laboratory Information Management Systems (LIMS) such as KLIMS
  • Excellent organizational and inventory management skills
  • Ability to work independently and as part of a team
  • Strong communication and interpersonal skills

Job Duties

  • Perform drug substance lot release, inprocess, and stability testing in a GMP environment including PCR, cellbased assays, flow cytometry and RVV/LVV stability testing
  • Execute routine laboratory testing in a GMP environment and accurately document results using KLIMS
  • Perform routine sampling and sample management activities including sample aliquoting, shipping, and external submissions while maintaining sample integrity, traceability, and chain of custody
  • Manage daily sample and reagent operations including inventory control, organization, and traceability in compliance with GMP/GDP requirements
  • Conduct laboratory maintenance activities including biosafety cabinet cleaning, equipment cleaning, general lab upkeep, media preparation, reagent ordering, and laboratory stocking
  • Adhere to all GMP and GDP standards, site procedures, and safety requirements to ensure compliance and data integrity
  • Serve as a signedoff reviewer for assigned documentation in accordance with training
  • Assist in the execution of validation and verification activities following approved protocols and procedures
  • Support quality system activities including assistance with deviations, CAPAs, change actions, and other quality records under supervision
  • Assist in the assembly and maintenance of data trending reports including Quality Control Metrics to support continuous improvement and compliance monitoring
  • Participate in and support training activities including completion of required training and assistance with training documentation as needed
  • Support document revision activities with appropriate oversight
  • Perform additional duties as assigned

Job Criteria

Experience

No experience required


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