Gilead

QC Specialist II

United States - California - Santa Monica Full time

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

  • Lead method transfers to support accelerated timelines for early clinical pipelines and internal product lines, partnering with cross‑functional teams across Analytical Development, site QC, and external sites as needed.
  • Perform routine equipment audits and system backups to ensure data integrity and system availability.
  • Serve as System Administrator, managing user access, security, and permissions for GMP laboratory systems.
  • Collaborate with cross‑functional partners (Facilities, Engineering, IT) on the maintenance, qualification, and operation of QC laboratory equipment and systems.
  • Act as a QC representative for specialized areas during site‑level meetings and initiatives.
  • Support and participate in internal, external, and regulatory inspections, including preparation and direct inspection support.
  • Resolve data discrepancies and missing information to support continuous quality improvement.
  • Develop, revise, review, and maintain SOPs, qualification/validation protocols, and technical reports.
  • Monitor GMP laboratory systems to ensure compliance with documented policies, procedures, and regulatory requirements.
  • Provide on‑the‑job training and day‑to‑day technical guidance to QC Lab Services staff under appropriate supervision.
  • Perform QC sample receiving, processing, storage, distribution, and disposal in compliance with GMP requirements.
  • Gather quality metrics and perform trend analysis to identify opportunities for improvement.
  • Support ad‑hoc projects and additional duties as assigned.
  • Conduct and support OOS, OOT investigations, Deviation investigations, CAPAs, and Change Controls related to QC equipment and system management.
  • Serve as Point of Contact (POC) for internal and external inspections related to QC equipment and systems.
  • Work independently with minimal supervision; proactively identify, troubleshoot, and communicate issues to stakeholders.
  • Use strong verbal and interpersonal communication skills to provide technical insight and achieve assigned objectives.
  • Maintain a strong commitment to lab safety, supporting a goal of zero OSHA recordable incidents.
  • Work flexible hours across a seven‑day workweek, including overtime, weekends, or holidays, as operational needs require.
  • Perform physical activities including lifting up to 25 lbs and working with dry ice and LN₂ freezers.
  • Delegate responsibilities to qualified deputies, as appropriate.

Basic Qualifications

  • Bachelor’s degree with at least 4 years, or Master’s degree with at least 2 years, of hands‑on laboratory experience in a biotech or biopharmaceutical setting.
  • Experience working in a GMP or regulated environment.
  • Ability to work independently and manage multiple projects simultaneously.
  • Strong oral and written communication skills and demonstrated interpersonal effectiveness.

Preferred Qualifications

  • Hands‑on experience with biological and biochemical analytical methods, including pH, osmolality, conductivity, visual inspection, and protein assays.
  • Experience with ELISA, qPCR, ddPCR, and flow cytometry (e.g., FACS Canto, CytoFlex).
  • Experience performing safety and microbiological assays, including mycoplasma and endotoxin testing.
  • Experience supporting QC equipment qualification, validation, and system administration in GMP laboratories.
  • Familiarity with quality systems including Deviation, CAPA, Change Control, OOS, and OOT investigations.
  • Strong attention to detail with a continuous improvement mindset.


 

The salary range for this position is: $92,820.00 - $120,120.00. 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.
 

For jobs in the United States:

Kite Pharma 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.


For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT


Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the  legal duty to furnish information; or (d) otherwise protected by law.
 

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.


Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.