Overview
Skills
Job Details
We are seeking a Technical Writer with a strong scientific background to support documentation and compliance in a regulated biotech/pharma lab environment.
Key Responsibilities:
Write and revise SOPs, protocols, technical reports, CMC sections, and regulatory documents
Author and manage deviations, investigations, and change controls
Work with Empower, LIMS, TrackWise, Veeva, and SAP systems
Coordinate with vendors, manage testing shipments, and process invoices
Support GMP/GLP compliance and stability trending
Collaborate with lab analysts and QC teams as needed
Qualifications:
BS in Chemistry, Biology, or related science
2+ years in a scientific or analytical lab (biologics/monoclonal antibodies preferred)
Strong technical/scientific writing experience
Proficient in Empower, LIMS, Veeva, SAP, TrackWise
Knowledge of GMP/GLP practices
Advanced skills in Microsoft Word, Excel, and SharePoint