Senior, Associate I, Technical Services - $8,000* Sign On

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 Sr. Associate I, Technical Services, 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):

Perform all tasks associated with Quality Record Management and Initiation and collaboratively resolve issues.

Develop concise and accurate Process Comments,

Author Minor and Major Deviation Investigations and Major Impact Assessments.

Support MTS and collaborate with MSAT, QE, QC, MFG, QA, and Facilities on assigned tasks.

Execute and collaborate with MFG on Human Error Reduction CAPAs/Right First Time Initiatives.

Maintain Quality Record/Tech Writing Team metrics, identify and support improvement efforts with Tech Writer Lead.

Strong understanding of the Manufacturing Process.

Ability to support shift work and potential overtime.

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

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

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

Maintain on-time completion of all required training

Maintain gowning certification and Aseptic Operator Qualification (as applicable)

Other tasks and duties as assigned by Management

Basic Qualifications:

• Master’s degree Or
• Bachelor’s degree with 2+ years of experience in engineering, manufacturing and quality in biotech/pharma industry Or
• AAA degree with 4+ years of experience in engineering, manufacturing and quality in biotech/pharma industry Or
• High School degree with 5+ years of experience in engineering, manufacturing and quality in biotech/pharma industry

Preferred Qualifications:

• BS in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent with 3+ years of experience.  Engineering degree preferred
• 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
• 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

*This Position qualifies for a $8,000 Sign-on Bonus, $4,000 payable within 30 days of start date and $4,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue. Applies to external hires only.