LanceSoft, Inc.
Technical Writer
LanceSoft, Inc. - Lexington
Work at LanceSoft, Inc.
Overview
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Overview
Job Description
- Primary duties are non-laboratory support of the QC analytical methods functions in method validation and method transfer projects.
- Primary activities would generally include but not limited to
- Authoring analytical method and support documentation for QC release and stability testing of biologics.
- Authoring method validation protocol and reports to support technology transfers.
- Creation, review, and revision of comprehensive method validation protocol, reports, , ensuring accuracy and adherence to ICH, FDA, EMA, regulatory standards.
Specific QC Focus Area
- Analytical Methodologies for potency, impurities, content, and identity attributes in biologics (recombinant proteins, antibodies, ADCs, fusion proteins, enzymes, etc.).
- (i.e.: cell based assays, residual ProteinA, host cell protein, residual DNA, protein determination)
- If possible, proven hands-on testing experience in QC laboratories.