Process Engineer Compliance

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.

We are seeking a highly motivated individual for the role of Process Engineer, Complianceto work in this excitingnew area of cancer immunotherapy. The Materials Management Department supports corporate manufacturing and quality goals to ensure the supply of Kite's therapy to the patient. In this role you will be focused on the compliance and documentation activities related to product shipping, component sanitization, and component receiving; closely collaborating with the Quality department.

Responsibilities (include but are not limited to):

• Manage and track deviations, change controls, CAPA's, and customer complaints within the Materials Management department.

• Coordinate efforts across multiple departments to gather supporting justification data to determine appropriate corrective and preventative actions.

• Initiate change control as related to investigations, procedural changes, and other system/equipment upgrades.

• Support internal/external inspections by completing responses and tracking commitments.

• In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations/investigations through comprehensive Root Cause Analysis tools.

• Represents Materials Management operations in change control, CAPA, and deviation meetings.

• Devises and implements CAPAs to address root cause and ensure effectiveness.

• Collaborating with technical and operational stakeholders, writes and/or revises SOPs, work instructions, and other operational related documents

• Trends key performance metrics

• Participates in internal audit/inspection

• Conducts training

• Manages specific projects to meet established timelines.

• Other tasks and duties as assigned by Management.

Requirements:

• Bachelors' Degree in life sciences with 5 to 7 years of related professional experience; Quality background preferred

• Experience leading projects is required

• 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

• Technical writing

• Provides training and guidance to others

• Experience leading cross functional teams

• Facilitates cross functional and team meetings.

• Knowledge of ERP systems implementation is desirable

• Proficiency in using Microsoft Word, Excel, Presentation, Access, and Project is required.

• 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

#LI-HH1

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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