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Senior Manager, Manufacturing / Associate Director (Swing Shift) El Segundo United States,  

Posted on : 03 July 2017

Project Description

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 Sign up to follow @KitePharma on Twitter at Kite is seeking a highly-motivated individual with cell culture and/or drug product manufacturing experience to oversee a team of supervisors and cell therapy manufacturing specialists in a clinical/commercial pharmaceutical environment. Responsibilities (include but are not limited to): Oversee the on-the-floor operations of our commercial cell therapy manufacturing facility in a cGMP environment Build a team, provide necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews Generate SOPs, MPRs, and SPRs for equipment and procedures used in routine biologics manufacture Execute production and resource schedule against operational plan Ensure performance of all process steps specific to the phase or stage of operation (e.g. upstream, downstream, support) Process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements Complete the final review of completed manufacturing documentation per compliance standards and established timelines Investigate and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management Interact with outside vendors and senior management Participate in multi-functional project teams, as necessary Take corrective action to bring about required changes using change control procedures Other duties as assigned Requirements: Bachelor s degree in biology or related field with at least 12 years of experience managing a manufacturing team in the biotechnology or biologicsindustry (advanced degree preferred) Able to build and manage a team as well as train entry-level personnel Knowledgeable of the current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's) Sufficient understanding of process, systems and equipment to troubleshoot problems and provide solutions to senior management Expert knowledge of electronic quality systems Must be able to work on off shift hours as well as part of the on-call rotation as needed is required; weekend shift likely Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment High energy level and a positive outlook coupled with the requisite can do  attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles Willingness to think outside of the box and adapt best practices to our small, but growing environment Ability to adapt in a constantly evolving environment Self-motivated with a strong sense of ownership in areas of responsibility Previous cell culture and/or drug product experience preferred/highly desired


El Segundo CA

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