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Director, Clinical Viral Vector Manufacturing

Company: Kite Pharma
Location: Santa Monica
Posted on: November 17, 2019

Job Description:

This individual will be an integral member of the viral vector team at Kite. This person will contribute to the development, scale up and technology transfer for production of various viral vectors. The individual will be responsible for operation of the clinical viral vector facility, hence supporting a team of specialist in the viral vector manufacturing area. The individual is accountable for successful operation of a clinical viral vector plant. The person will be playing a major role in the technology transfer from process development team and successful operation of the scaled-up process. Furthermore the individual along with the future manufacturing team will be responsible for establishments of systems for process monitoring, maintenance of production equipment and facilities in the manufacturing areas and proper documentation. The individual will be ultimately responsible for compliance with the with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies and safety practices. Responsibilities (include but are not limited to): Oversight and lead activities to ensure facility operational readiness for production of clinical grade material Oversee day to day operation of the clinical manufacturing operation by followings : Manage installation and commissioning of the required equipment Work closely with QC and QA representatives to ensure proper steps are in place for procurement of raw material, testing and release. Build a system to control process intermediate testing and final product release Work closely for process development team to build up a framework for technology transfer of process specifics for scale up to ensure scalability and robustness of the process. Oversee the ongoing documentation related to the batch record preparation, sampling plan and process monitoring data Communicate, interact and influence with Manufacturing Leadership Team and functional department heads Drive business standards and a high level of compliance through effective monitoring and reporting of key performance metrics Develop internal viral vector storage and inventory management system Build internal subject matter expertise for viral vector CMO management teams Manufacturing leader for process alignment, technology transfer and product/process related initiatives Create an environment where productivity and efficiency are achieved and recognized Establish operational objectives and assignments Anticipate and address inspection issues that impact plant operations Maintain a high level of compliance through effective monitoring and reporting of key quality metrics Ensure timely execution of CAPA, change control and continuous improvement initiatives Manufacturing leader for inspection activities, observation commitments, submission and agency requests for products for assigned manufacturing plant Identify key areas for change and alignment and mobilize organization to make changes happen Build a team, provide necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews Influence and/or develop broad-based programs and initiatives to meet executive level vision and mission Collaborate with functional leaders to set strategy and shared objectives Accomplish results through the management of a team of managers, professional employees and/or other leaders Develop and administer budgets, schedules, objectives and goals Requirements: Bachelors degree in biology or related field (or equivalent experience required), advanced degree preferred with at least 15 years of experience managing a manufacturing team in the biotechnology or biologics industry, preferably with 5+ years as a leader of leaders Strong understanding of the business, science, engineering, and technology of biotechnology, processes, equipment and facilities Knowledgeable of the current Regulations, Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's) Expert knowledge of electronic quality systems 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 viral vector or biologics traditional process is desired Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission! #LI-MH1 #IND123 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: As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 careers@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION 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. Gilead 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 log onto your Internal Career Site to apply for this job.

Keywords: Kite Pharma, Cypress , Director, Clinical Viral Vector Manufacturing, Other , Santa Monica, California

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