Technical Writer

Location: Exton PA 19341 (Hybrid; 2-3 days per week in office) Technical Writer, Analytical Outsourcing, Biopharmaceutical Development Required proficiency in configuration, creating methods, reports, and custom calculations. While not required, it would be a plus if this person had experience with validation of custom fields Job Responsibilities: Author technical reports, policies, and Standard Operating Procedures. Author/review, format, and revise reports, protocols, analytical method validations, and CMC sections for regulatory submissions. Author investigations, deviations, change controls, and other non-conformance records. Work with vendors to coordinate testing and arrange shipments as needed. Compile and review scientific data for completeness as needed. Perform trending and evaluation for continuous monitoring of stability data and shelf-life extension. Use of LIMS database including protocol setup, data entry/approval, and data trending. Process invoices, purchase orders, and other agreements. Interact with finance and vendors to confirm work and adjust budget forecasts. Coordinate document review, approval, and archiving. Participate in analytical lab activities, on an as needed basis. Skills: Proficiency in Scientific Writing/Technical Writing, Experience in Empower chromatographic data system, Experience with LIMS, SAP/SRM, Track Wise, and Veeva, Experience in GMP/GLP and/or a regulated industry. Education/Experience: At least 2-3 years scientific/analytical lab experience, preferably in the field of protein therapeutics or monoclonal antibody therapies. Proficient in scientific/technical writing. Experience in Empower chromatographic data system Experience with LIMS, SAP/SRM, Track Wise, and Veeva. Excellent oral communication, interpersonal and technical writing skills. Excellent organizational skills, demonstrate attention to detail. Experience in GMP/GLP and/or a regulated industry. Strong background in Microsoft applications such as Word, Excel, SharePoint a must. Advanced Excel knowledge is a plus. BS in Chemistry, Biology or a related scientific discipline.