Supervisor, Quality Control

Kite Pharma•El Segundo, CA

5d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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.

Responsibilities

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.