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Cell Therapy Vector Technical Writer
2 months ago
Job Overview:
As a Technical Writer specializing in MSAT for Cell Therapy Vector Support at Axelon Services Corporation, you will play a pivotal role in documenting and analyzing non-conformance events within the manufacturing process of cell therapy vectors.
Key Responsibilities:
- Analyze and compile manufacturing process data to identify potential failure modes.
- Acquire knowledge of complex cell biology concepts and apply them to root cause analyses.
- Collaborate independently and with Process Engineers to investigate various failure modes.
- Engage with GMP Quality Systems to produce comprehensive Root Cause Analysis reports.
Qualifications:
- Bachelor’s degree in Biological/Chemical Science, Engineering, or a related discipline.
- Background in Immunology is preferred.
Required Experience:
- Minimum of 3 years of relevant experience in the biopharmaceutical industry or similar.
- Proficiency in deviation writing.
Skills and Competencies:
- Ability to manage multiple investigations effectively to meet project deadlines.
- Strong scientific knowledge and technical writing capabilities.
Preferred Experience:
- Familiarity with quality management systems.
- Advanced problem-solving skills, particularly in root cause analysis.
- Experience in cross-functional collaboration with engineering and quality teams.
- Knowledge of biologics or cell therapy manufacturing processes.
- Training in Kepner Tregoe Problem Solving methodology.
