Kite Pharma · 7 hours ago
QC Specialist II
Oceanside, CA
Full-time
Onsite
Mid Level
$93K/yr - $120K/yr
4+ years expKite Pharma is a biopharmaceutical company focused on developing innovative cancer immunotherapies. They are seeking a highly motivated Quality Control Specialist II to support their efforts in cancer immunotherapy, responsible for executing analytical methods, providing training, and supporting regulatory activities.
BiotechnologyHealth CareMedicalOncologyTherapeutics
Responsibilities
Execute the transfer and validation of analytical methods to Oceanside, CA, QC
Provide Training on Analytical methods
Perform drug substance lot release and in-process testing and stability using PCR, cell-based assays and/or flow cytometry (multiple colors preferred) in a GMP environment
Provide support for assay performance and troubleshooting of analytical issues in the context of a GMP laboratory
Experience using 'LIMS' lab information management System
Support deviations, investigations, CAPAs and change control activities and Laboratory Investigations/OOS
Assist in establishing user requirements for purchase and qualification of Kite’s QC analytical equipment and materials/reagents
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
Assist with daily sample and reagent management activities such as receipt, aliquoting, organization, inventory control, and maintaining traceability in accordance with GMP/GDP expectations
Identify and lead teams for lean improvement activities
Up to 10% domestic travel
Capability to lift and move items weighing up to 50 lbs on an occasional basis
Additional duties as assigned
Qualification
Required
Master's Degree and 4+ years' pharmaceutical experience OR
Bachelor's Degree and 6+ years' pharmaceutical experience
Execute the transfer and validation of analytical methods to Oceanside, CA, QC
Provide Training on Analytical methods
Perform drug substance lot release and in-process testing and stability using PCR, cell-based assays and/or flow cytometry (multiple colors preferred) in a GMP environment
Provide support for assay performance and troubleshooting of analytical issues in the context of a GMP laboratory
Experience using 'LIMS' lab information management System
Support deviations, investigations, CAPAs and change control activities and Laboratory Investigations/OOS
Assist in establishing user requirements for purchase and qualification of Kite's QC analytical equipment and materials/reagents
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
Assist with daily sample and reagent management activities such as receipt, aliquoting, organization, inventory control, and maintaining traceability in accordance with GMP/GDP expectations
Identify and lead teams for lean improvement activities
Up to 10% domestic travel
Capability to lift and move items weighing up to 50 lbs on an occasional basis
Additional duties as assigned
Preferred
Experienced in cell and gene therapy
Strong working knowledge of GMP
Strong background in Flow Cytometry testing and sound knowledge of Flow Cytometry scientific principles
Strong background and knowledge in Droplet Digital PCR testing
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Kite Pharma
Kite Pharma is a biotechnology company that designs and develops immune-based therapies to treat cancer indications.
1001-5000 employees
H1B Sponsorship
Kite Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (54)
2024 (47)
2023 (54)
2022 (59)
2021 (53)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$335.38MKey Investors
Alta Partners
2017-08-28Acquired
2015-12-10Post Ipo Equity· $250.12M
2014-06-20IPO
Leadership Team
Craig Vermeyen
Director, Packaging and Labeling
Mark Jurgens
Executive Director, Head of External Scientific Collaboration
Recent News
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