Lab Ops Specialist II jobs in United States
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Kite Pharma · 23 hours ago

Lab Ops Specialist II

Kite Pharma is a biopharmaceutical company focused on developing innovative cancer immunotherapies. The Lab Ops Specialist II will be responsible for quality control sample processing, maintaining lab equipment, and supporting regulatory compliance, all while contributing to the company's mission of curing cancer.

BiotechnologyHealth CareMedicalOncologyTherapeutics
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Perform QC sample receipt, processing, and distribution for testing and storage
Perform Apheresis accession, inspection, and assist QA with product returns
Maintain and operate equipment and instruments supporting sample processing
Work with internal resources to maintain the lab in an optimal state
Perform cryo sample disposition and shipment
Track inventory of lab supplies, retain samples, stability samples, and test materials
Track and distribute samples according to stability protocols
Support on-the-job training for junior staff
Troubleshoot standard issues and identify deviations from standard processes
Own deviations, CAPAs, and change controls when necessary
Gather metric information for continuous improvement of areas of responsibility
Perform data entry and review
Support generation of Certificates of Analysis (CoAs) for product release
Assist in preparation of dossiers and data packages for interactions between Kite and regulatory agencies, if needed
Develop, revise, and review SOPs, work instructions, forms, sampling plans, qualification/validation protocols, and reports
Support investigations regarding out-of-specification (OOS) results, out-of-trend (OOT) events, and other unexpected laboratory events
Monitor GMP systems to ensure compliance with documented policies
Evaluate current operational processes and practices for efficiency and potential improvements
Work with LIMS administrators to incorporate new processes for sample management in LIMS
Assist with audits, walkthroughs, and inspections when necessary
Perform additional duties as assigned
Duties may be delegated to qualified deputies as needed

Qualification

Quality Control experienceGMP knowledgeSOP developmentLabVantage LIMSRegulatory requirements knowledgeData entryCommunication skillsTeamworkAdaptabilityTechnical writing

Required

BS degree in a scientifically oriented field and at least 2 years related work experience
OR
MS degree in a scientifically oriented field and at least 0 years related work experience
OR
AS/AA degree in a scientifically oriented field and at least and 4+ years of experience in Quality Control/GMP environment

Preferred

Degree in biotechnology or related field with Quality Control experience
Working knowledge of GMP, SOPs, and quality control processes
Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211)
Proficient in MS Word, Excel, PowerPoint, and other applications
Ability to communicate and work independently with scientific/technical personnel
Strong written and verbal communication skills
Comfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities
Experience with LabVantage LIMS
Flexibility to work variable schedules, including weekends, as business needs require

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

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Kite Pharma is a biotechnology company that designs and develops immune-based therapies to treat cancer indications.

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 Company
Total Funding
$335.38M
Key Investors
Alta Partners
2017-08-28Acquired
2015-12-10Post Ipo Equity· $250.12M
2014-06-20IPO

Leadership Team

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Craig Vermeyen
Director, Packaging and Labeling
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Mark Jurgens
Executive Director, Head of External Scientific Collaboration
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Company data provided by crunchbase