Supervisor, Quality Control

Were 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. Weve 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 **Shift: Wednesday-Saturday, 12:00pm-10:30pm** Specific Responsibilities (including but are not limited to): Lead a team of high-performing individuals, with particular focus on individual development in support of greater team achievement. Drive a culture of Operational Excellence in the group. Supervise Analytical QC testing and various other support activities performed in the Analytical QC Lab. Review of records, generation of CoAs for product release. Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Responsible for overseeing on-time completion of training for the group. Monitor GMP systems currently in place to ensure compliance with documented policies. Expectation includes a hands-on, collaborative approach to problem solving, planning, and people-management. Participate in and support development and implementation of Operational Excellence initiatives to enhance laboratory and staff efficiencies. Participate and/or lead daily and weekly team meetings. Work with internal and external resources to maintain analytical equipment in an optimal state. Oversee purchase and qualification of equipment, materials and media required for routine testing and reagent qualification. Responsible for OOS, lab and protocol deviations, and corrective action plan implementation when necessary. Provides input and support in the development, revision and review of SOPs, protocols and reports. Participate in inspections by both internal and external stakeholders as needed. Basic Qualifications: MA / MS Degree with 3+ years of analytical and/or cGMP operations and/or quality experience OR BA/BS Degree with 5+ years of analytical and/or cGMP operations and/or quality experience OR High School Degree with 9+ years of analytical and/or cGMP operations and/or quality experience Preferred Qualifications: Experience supervising/managing analytical labs within the biotechnology or pharmaceutical industry. Demonstrated guidance and overseeing skills, including establishing direction and goals, and guiding implementation while fostering a team-based environment. Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment. Experience in any of the following analytical techniques, Flow Cytometry, PCR, ELISA, cell viability measurement. Familiarity with FDA, EU and ICH guidelines. Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, GMPs, GLP. Comfortable in a fast-pace company environment with minimal direction and able to adjust workload based on changing priorities. Ability to think critically and demonstrate troubleshooting/problem solving skills. Excellent skills in Microsoft Office, data analysis software, and other related applications. 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. 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 dont take success for granted. While weve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.