Overview
Technical Writer Jobs in Lexington, Massachusetts, USA at LanceSoft
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 are 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 and reports, ensuring accuracy and adherence to ICH, FDA, EMA, and 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.).
For example: cell-based assays, residual Protein A, host cell protein, residual DNA, protein determination.
If possible, proven hands-on testing experience in QC laboratories.
Experience Requirements
Independent Technical Writing Skills in Quality Control and Regulatory departments (must perform the designated author role, not just the reviewer/approver role).
Expert knowledge in data analysis.
Experience on test methods and method validation for internal teams and external partners.
Key Skills
Skilled in proper laboratory compliance through detailed documentation practices.
Experienced in the use of electronic laboratory notebooks and electronic data storage systems to maintain accurate records.
Strong written, verbal, and interpersonal communication abilities, successful in a team environment.
Familiarity with LIMS and Empower software platforms.
Must have knowledge of periodic documentation of assay trends, to maintain compliance and improve operational efficiency.
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Title: Technical Writer
Company: LanceSoft
Location: Lexington, Massachusetts, USA
Category: Healthcare (Data Scientist), Quality Assurance – QA/QC (Data Analyst)
