Technical Writer - Axelon Services Corporation

Job Description: MSAT Technical Writer, Cell Therapy Vector Support ,Support, Manufacturing Science and Technology (MSAT)

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:
Required 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
Additional Job Requirements:
None