Supervisor, Quality Control Analytical

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

Gilead Sciences is looking to hire a Supervisor, Quality Control Analytical.

Job Responsibilities & Requirements include but are not limited to:

Leadership

Experience with leadership, people management, and project management

• Demonstrated leadership and management skills, including establishing direction and goals, and building good work ethics for the team
• A minimum of 3 years' experience supervising/managing is preferred

Routine Testing Support

The ideal candidate is well versed in various analytical methods (flow cytometry, potency ELISA, qPCR/ddPCR) in a cell therapy environment to support QC data review & COA generation to support on-time patient/stability testing and release

• Supervision of all QC Analytical laboratory scheduling and testing to meet timelines
• Supervisor/Manager review of QC Data and Generation of CoAs for on-time product release
• Complete routine review of QC test data and related documents for stability, reagent release, etc.
• Monitor and trend QC data results
• Management of QC Analytical training program

Maintaining Operations

Provide updates/escalations at daily and weekly site-specific and cross-site meetings Experience with method development/qualification, tech transfer, QC testing, and laboratory deviations/investigations

• Conduct investigations regarding out of specifications (OOS) results and address/manage deviations related to analytical procedures
• Review & approve laboratory deviations and lab investigations
• Review & approve as SME site-specific and global SOPs and forms
• Develop, revise and review SOPs, qualification/validation protocols and reports
• Provides technical support for SOP & protocol writing & review.

Audits & Compliance

Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/ 210/ 211) Knowledge of regulatory requirements for data integrity and practices. Audits & compliance

• Knowledge of regulatory guidance and experience maintaining QC lab GMP compliance and audits
• Monitor the GMP systems currently in place to ensure compliance with documented policies
• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate

General

• Experience with LIMS
• Knowledge of CAR-T manufacturing, micro methods (e.g., sterility, endotoxin, and environmental monitoring), and equipment IQ/OQ/PQ/PV a plus
• Proficient in MS Word, Excel, Power Point and other applications
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload and flexibility based upon changing priorities
• Gather metric information for use in continuous improvement of areas of responsibility Other duties as assigned

Knowledge:

• Experience with analytical methods (flow cytometry, potency ELISA, and ddPCR/qPCR) in a cell therapy environment to support QC testing, data reviews, & COA generation to support patient/stability testing and release
• Experience with leadership, people management, and project management
• Experience with method development/qualification, tech transfer, QC testing, and laboratory deviations/investigations
• Knowledge of regulatory guidance and experience maintaining QC lab GMP compliance and audits

Specific Education & Experience Requirements:

• 5+ years of relevant experience and a BS or BA. OR
• 3+ years of relevant experience and a MS.
• Prior management experience in pharmaceutical industry is preferred

The salary range for this position is: $107,185.00 - $138,710.00. 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 in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

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For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.