Senior/Principal Technical Specialist, Manufacturing - United States
Want to know company name or location? Company managed [?]
- 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.
- 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