Lab Ops Specialist II

Kite Pharma • Santa Monica, CA

1d

About The Position

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.

Requirements

• 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

Nice To Haves

• 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.

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.

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees