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 Manufacturing Specialist to support an 18,000 square foot 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:
- Manages specific projects to meet established timelines.
- Facilitates cross functional and team meetings.
- 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.
Bachelors’ Degree in life sciences with >7 years of related professional experience
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
Proficiency in using Microsoft Word, Excel, Presentation, Access, and Project is required.
Knowledge of ERP systems implementation is desirable