QC Specialist I

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

Key Responsibilities

• Perform testing of raw materials, intermediates, final products, and stability by following analytical methods.
• Maintain, calibrate, and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA, and PCR assays.
• Track and test products according to stability protocols.
• Work with internal and external resources to maintain the lab in an optimal state.
• Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance, and drug product release. Generate Certificates of Analysis (CoAs) for product release.
• Assist in the preparation of dossiers and data packages for interactions between Kite (Gilead) and regulatory agencies; participate in Pre-Approval Inspections.
• Develop, revise, and review SOPs, qualification/validation protocols, and reports.
• Conduct investigations regarding out-of-specification (OOS) results and manage deviations related to analytical procedures. Provide updates at daily and weekly meetings.
• Monitor GMP systems to ensure compliance with documented policies.
• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies as appropriate.
• Gather metric information for continuous improvement of areas of responsibility.
• Perform other duties as required.

Basic Qualifications

• 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.

Preferred Qualifications

• At least 2 years of industry experience in a biotech and/or pharmaceutical quality-related role.
• Strong knowledge of GMP, SOPs, and quality control processes.
• Experience identifying, writing, evaluating, and closing OOS investigations.
• Proficient in MS Word, Excel, PowerPoint, and other applications.
• Strong written and verbal communication skills.
• Ability to communicate and work independently with scientific/technical personnel.
• Well-versed in analytical techniques such as Flow Cytometry, ELISA, PCR, and cell bioassays for biopharmaceutical testing.
• Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211).
• Flexibility to work alternate schedules, including weekends, as business needs require.

 

The salary range for this position is: $80,325.00 - $103,950.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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.

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 i