Technical Writer, Analytical Outsourcing, Biopharmaceutical Development

Franklin Ctr, PA 19341

Posted: 04/07/2025 Employment Type: Contract Job Category: Other Job Number: 618900 Is job remote?: Hybrid Country: United States

Job Description


Target Pay Rate: 30-38.66/hr **salary will be commensurate with experience 

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.

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.
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About Franklin Ctr, PA

Ready to take the first step towards a fulfilling career in Franklin Center, Pennsylvania? This vibrant area, nestled in the heart of beautiful Bucks County, offers job seekers a unique blend of opportunities for growth and success. From its close proximity to iconic attractions like the historic Fonthill Castle and the bustling Peddler's Village, to its thriving arts scene featuring the James A. Michener Art Museum and the Bucks County Playhouse, Franklin Center is a hub of culture and charm. With delectable local cuisine, picturesque parks like Peace Valley Park for outdoor enthusiasts, and easy access to Philadelphia's professional sports teams and renowned venues, this region promises an enriching career experience like no other. Explore our job listings now and discover the endless possibilities waiting for you in Franklin Center, Pennsylvania!