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Cell Therapy Vector Technical Writer
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Cell Therapy Vector Technical Writer
3 weeks ago
Libertyville, Illinois, United States Axelon Services Corporation Full timeJob 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...
Technical writer
4 months ago
Job Title: Technical writer
Job ID: 24-02354
Location: Libertyville, IL, 60048
Duration: 06 Months contract on W2
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.
