Specialist, Technical Manufacturing

Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

We are seeking a Specialist, Technical Manufacturing to support an 18,000 square foot clinical biotechnology facility in Santa Monica that includes general laboratories for bio-processing.Under minimal supervision, this position's main accountabilities are focused on the manufacturing operations compliance and technical documentation activities and closely collaborates with the Quality Unit.

Responsibilities include, but are not limited to:

• Provide front line technical support for manufacturing of cell therapy products (on-call support required time varies by project/SME assignment)

• Manages specific projects to meet established timelines.
• Facilitates cross functional and team meetings and projects.
• Represents Manufacturing operations in change control, CAPA and deviation meetings.
• In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations/investigations through comprehensive Root Cause Analysis tools.
• Devises and implements CAPAs to address root cause and ensure effectiveness.
• Collaborating with technical and operational stakeholders, writes and/or revises SOPs, batch records, and other operational related documents.
• Trends key performance metrics.
• Participates in internal audits/inspections.
• Conducts training to Cell Therapy Specialists.
• Participates in the implementation of ERP systems.
• Other tasks and duties as assigned by Management.
• Responsible for manufacturing recipe & formulas in Oracle EBS and associated documentation.
• Trending of material issues and ownership of SCARs.
• Implementing material changes and process improvements.

Basic Qualifications:

• Masters' Degree in life sciences with
• Bachelors' Degree in life sciences with 2+ years of experience in biotech or pharma Or
• AA Degree in life science with 4+ years of experience in biotech or pharma OR
• High School Degree with 5+ years of experience in biotech or pharma

Preferred Qualifications

• Cell culture, cell/gene therapy and/or aseptic processing experience
• Broad technical knowledge of cGMP compliance and experience with leading investigations, writing, deviation reports, change controls, and corrective actions
• Experience with investigation and root cause analysis tools
• Skilled at creating and delivering presentations
• Experience leading cross functional teams to obtain project deliverables
• Utilizes technical writing strategies to ensure content is clear and concise
• Provides training and guidance to others
• Experience with GMP manufacturing equipment.
• Experience with Oracle EBS.
• Proficiency in using Microsoft Word, Excel, Presentation, Access, and Project.

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!

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.

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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 contactcareers@gilead.comfor assistance.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.