Analysis Skills, Cell Biology, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Processing, Drug Products, Establish Priorities, GMP (Good Manufacturing Practices), Investigative Reports, Manufacturing, Manufacturing Analysis, Manufacturing/Industrial Processes, Problem Solving Skills, Process Engineering, Quality Management, Root Cause Analysis, Technical Writing, Time Management, Writing Skills
MSAT Technical Writer, Cell Therapy Vector Support
The focus of the MSAT Technical Writer is to investigate and write root cause analyses for non-conformance events during the manufacturing of cell therapy vector. The MSAT Tech Writer:
- Compiles and interprets manufacturing process data to identify possible failure modes
- Learns complex cell biology concepts & applies them to root cause investigations
- Works independently and with Process Engineer(s) to understand different failure modes
- Works with GMP Quality Systems to deliver completed Root Cause Analysis investigation reports
Education:
- BS in Bio/Chem Science/Engineering or related field
- Immunology education preferred
Experience:
- 3+ years relevant experience in drug product biopharmaceutical or equivalent industry
- Deviation writing
- cGMP/cGDP
- Ability to prioritize multiple investigations in order to meet deadlines
- Strong scientific and technical acumen including technical writing skills
Preferred experience:
- Quality management system
- Complex problem-solving skills, including root cause investigation
- Cross-functional collaboration with engineering and quality partners
- Biologics or cell therapy manufacturing
- Trained in Kepner Tregoe Problem Solving
Duties and Responsibilities:
- Facilitates deviation closure through working with quality partners and site quality systems
- Analyzes and summarizes manufacturing data to support root cause investigations
- Analyzes and summarizes characterization data to write root cause investigations
- Utilizes root cause analysis tools such as fishbone, 6Ms, Five Whys, to identify root cause
- Writes technical and thorough investigation reports