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Senior/Principal Technical Specialist, Manufacturing - United States
Kite Pharma (company)
Posted on : 03 July 2017
- Our company 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.
- We are seeking a Senior/Principal Manufacturing Technical Specialist to support a 44,000-square foot biotechnology facility that includes general laboratories for bio-processing.
- Under minimal supervision, this position’s main accountabilities are focused on the frontline technical support of manufacturing operations while closely collaborating with the Quality and Product Sciences Unit.
Responsibilities include, but are not limited to:
- Provide front line technical support for manufacturing of cell therapy products
- Ensure successful manufacturing production runs by assessing risk, implementing preventative measures, investigating, and troubleshooting equipment and process issues
- Partner with Product Sciences Team to execute process development studies within commercial facility to further develop a thorough understanding of operating and performance parameters
- In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations through comprehensive use of 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 audit/inspection
- Represents Manufacturing operations in Change Control, CAPA and Deviation meetings
- Conducts technical training and guidance to the cell therapy specialists
- Participates in the implementation of ERP systems
- Other tasks and duties as assigned by Management
- BS in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent with 10 to 15 years of experience. Engineering degree preferred
- 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
- 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