Process Engineer I

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.

Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.

We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted. While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.

The Role of a Process Engineer I on the Manufacturing Technical Services (MTS) team supports the manufacture of our innovative cancer therapies. As a technical expert for our manufacturing process, you will support our operations and bring improvements to the manufacturing work areas.

You will be responsible for collaboration with manufacturing on adverse events to identify next steps and investigate for understanding. You will be responsible for improvement projects to improve operations, delivering more cancer therapies to our patients.

Responsibilities will include, but are not limited to, the following:

• Completes required training assignments to maintain necessary technical skills and knowledge and to ensure compliance with cGMP requirements

• Participate in the design and implementation of electronic batch records within a Manufacturing Execution System (MES)

• Provide front line technical support for manufacturing of cell therapy products

• Ensure successful manufacturing production runs by assessing risk, implementing preventive measures, investigating, and troubleshooting process issues

• Represent Manufacturing during the technology transfer of clinical and commercial products to the site

• Partner with process owners to execute studies in a laboratory setting to support investigations and continuous improvement efforts

• In conjunction with various internal and external partners, investigate and coordinate the timely resolution of deviations through comprehensive use of Root Cause Analysis tools

• Devise and implement CAPAs to address root cause and ensure effectiveness

• Trend key performance metrics

• Participate in internal and external audits/inspections

• Develop training content and conduct training sessions for Cell Therapy Specialists

• Work with Supply Chain to establish bill of materials and establish cost of goods manufactured

• Finds opportunities for improvement in manufacturing efficiencies and compliance while assisting with investigations/deviations and change controls

• Additional duties as assigned.

Basic Qualifications:

• BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 0-2 years of relevant experience or

• AA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 4 years of relevant experience or

• HS Diploma with 5 years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent

Preferred Qualifications:

• Proficiency with MS Office Suite

• Ability to identify issues and seek solutions

• Ability to work both independently and collaboratively

• Ability in cross functional teams in fast pace, dynamic team setting

• Efficient, organized, and able to handle short timelines in a fast-paced environment

• Experience and/or interest in the Biotechnology, Pharmaceutical or health-care industry

• Knowledge and understanding of Good Manufacturing Practices (GMP) and regulatory policies