Technical Writer

Job Title: Technical Writer
Location: Exton, PA  (Hybrid)
Duration: 12 Months+

Description:
Technical Writer, Analytical Outsourcing, Biopharmaceutical Development
 
Must Have Skills set:
Candidates unless they have EMPOWER experience.
Location: Exton, PA/Hybrid- 2-3 Days
 
Candidates must be local and able to work onsite ~2-3 days per week. May be more, as needed. M-F 8-5 regular schedule.
 
Scientific background, ideally pharma experience

• Experience in Empower chromatographic data system

 
Required:
Must Have:
• 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

 
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.


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