Technical Writer

Technical Writer

Technical Writer, Analytical Outsourcing, Biopharmaceutical Development

Scientific background, ideally pharma experience

Job Qualifications

• BS in Chemistry, Biology or a related scientific discipline.

• 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, TrackWise, 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.

Job Description

• 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 testing lab activities, on an as needed basis.