CMC Technical Writer - Tech Transfer & Process Chemistry
Core
CMC Technical Writer supporting late-stage lipid technical transfer and process chemistry for novel gene editing products by translating experimental data into scientifically rigorous documentation.
Role type
Senior IC technical writer (process chemistry)
Builds
Process characterization reports and regulatory-ready documentation for gene editing products
Domain
Biopharmaceuticals / Process Chemistry / Gene Editing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Small molecule synthesis and purification, Process characterization, Chromatography, Scaling design, cGMP documentation standards, 21 CFR Part 211, ICH Q guidelines, EDMS platforms, Data analysis, Report drafting
Preferred skills
RNA-LNP process chemistry, RNA-LNP process characterization, Risk assessments, Design of experiments (DOEs), Process performance evaluation
Technologies
MS Word, Excel, Veeva Vault, Documentum
Responsibilities
Draft conclusion-driven process development reports from protocol objectives, Transform raw experimental data into coherent tables and figures, Maintain traceable source documentation for regulatory submissions, Collaborate to establish best documentation practices, Develop reports aligned with internal templates and CMC standards, Capture process knowledge in a structured manner
Seniority
Mid-Senior, hands-on IC