Manager, IT Quality Engineering (LIMS) - El Segundo, CA or Frederick, MD at Kite Pharma

El Segundo, California, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Mar, 26

Salary

160380.0

Posted On

07 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Labvantage LIMS, Quality Control, Artificial Intelligence, Machine Learning, Good Manufacturing Practice, SQL, Quality Management Systems, Regulatory Compliance, Server Technologies, Network Technologies, Cloud Technologies, Scripting, Automation Tools, Data Integrity, Incident Management, Project Management

Industry

Biotechnology Research

Description

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 Manager – LIMS Cell Therapy IT 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 Gilead’s Cell Therapy IT team to support Kite Pharma, as they make even bigger advances in cancer therapies, and help shape where 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 Summary We are seeking an experienced IT professional with a strong background in LabVantage LIMS and Quality Control processes. The successful candidate will have both technical capabilities and an ability to influence and manage people. An understanding of Artificial Intelligence (AI), Machine Learning (ML) and IT infrastructure is also beneficial. Previous experience working in a Good Manufacturing Practice (GMP) environment is a must. This role will be responsible for working with Kite Quality Control to define requirements for their LIMS system with the goal of moving towards a paperless lab, work with other IT groups to ensure uninterrupted system uptime, and take on responsibilities of System Owner for the LIMS system (i.e., incident management, roadmap development/management). This role will collaborate with Gilead IT and vendors to ensure the reliability, performance and security of IT infrastructure hosting Kite’s LIMS application. Locations: El Segundo, CA or Santa Monica, CA or Frederick, MD Job Responsibilities Work with the business (Kite Quality) in defining and implementing LIMS technical solutions that support the ever-evolving needs of Kite Collaborate with Gilead IT Incident Command team to provide Level 2 support for incidents that can potentially interrupt Kite operations Assess, document, and deploy system patches in a controlled way that does not adversely impact business operations Successfully manage IT projects in collaboration with cross-functional teams Provide support for a Global Enterprise system (US-West Coast > US-East Coast > Europe) Work closely with Kite Quality Assurance, Quality Control, Stability, Gilead IT, and other teams Create, revise, and approve LIMS system SOPs and reports per GMP, FDA, EU, Global, and ICH guidelines Triage and evaluate site change requests, assess global impact, and prioritize accordingly Assist sites in identifying master data elements for LIMS deployment Ensure LIMS processes meet data integrity and GMP standards; promote global process adoption Basic Qualifications 6+ Years with BS/BA OR 4+ Years with MS/MA required 5+ years of experience in a GMP regulated environment 5+ years of experience in LabVantage LIMS 5+ years of experience with SQL Preferred Qualifications Strong understanding of FDA, ISO 13485, Medical Device Directive Prior experience managing a team Expertise in quality management systems and regulatory compliance Advanced computer skills and familiarity with quality management software Experience leading high-stakes engagements with tight coordination and rapid decision-making, ideally involving AI Deep knowledge of LabVantage processes such as sample management, batch release, stability, and lab execution Strong understanding of server, network and cloud technologies Experience with scripting and automation tools Understanding of security best practices and relevant regulations The salary range for this position is: $123,930.00 - $160,380.00. 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. Change The World With Us Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work. We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted. While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.

Responsibilities

The role involves defining and implementing LIMS technical solutions to support Kite Quality Control and ensuring system uptime. Additionally, the manager will oversee incident management and collaborate with various teams to maintain the reliability and security of the LIMS application.