Process Engineer III

Employer
Kite Pharma
Location
El Segundo, CA, United States
Posted
Oct 06, 2020
Ref
R0014436
Required Education
Bachelors Degree
Position Type
Full time
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

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 Process Engineer II, Cell Therapy to support our commercial biotechnology facility in El Segundo that includes general laboratories for bioprocessing.

Under minimal supervision, this position's main accountabilities are focused on the front line technical support of manufacturing operations while closely collaborating with the Quality and Product Sciences Unit.

Responsibilities (include but are not limited to):

Manufacturing Technical lead and SME for new product introductions (raw material implementation, equipment, system implementation)

Change Control owner/task owner for new production introductions

Develop strategy for jurisdictional control

Participate in cross-functional network teams as TCF03 MFG rep

Support Commercial and Clinical launches at TCF03

MFG Tech Transfer lead (receiving or sending unit)

Partner with Product Sciences Team to execute process development studies within commercial facility to further develop a thorough understanding of operating and performance parameters Ensure successful manufacturing production runs by assessing risk, implementing preventative measures, investigating, and troubleshooting equipment and process issues

Collaborating with technical and operational stakeholders, writes and/or revises SOPs, batch records, and other operational related documents as needed

Trends key performance metrics

Participates in internal audit/inspection

CAPA Audit owner as needed

Lead root cause investigations if needed

Represents Manufacturing operations in Change Control, CAPA and Deviation meetings

Conducts technical training and guidance to the Cell Therapy Specialists

lead in the implementation strategy of ERP systems (Oracle EBS, MES)

Other tasks and duties as assigned by Managements

Basic Qualifications:

BS in Biochemical Engineering, Chemical Engineering, Biotechnology with 5+ years of experience Or Ma/MS with 3+ years of experience in Biochemical Engineering or Chemical Engineering

Preferred Qualifications:

Cell culture 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

Proficiency in using Microsoft Word, Excel, Presentation, Access, and Project

Utilizes technical writing strategies to ensure content is clear and concise

Possesses good communication skills

Experience leading cross functional teams to obtain project deliverables

Working knowledge of scientific and engineering principles

Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar is a plus

Knowledge of ERP systems implementation is desirable

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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For Current Kite Pharma Employees and Contractors:

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