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Technical Writer

3 months ago

Frederick, United States Unicon Pharma Inc Full time
Job DescriptionJob Description

Position Overview:

At Client, they work together across global boundaries to make an impact and find answers to challenges. This is a truly exciting period for us at Client. They have a pipeline that presents outstanding opportunities to push the boundaries of science to deliver medicines to patients which will positively impact their lives. The successful applicant will be responsible for creating technical instruction documents including standard operating procedures (SOPs), explaining complex information in a clear and concise manner and working with manufacturing experts to ensure accuracy of process descriptions.

Position Description:

The Technical Writer is responsible for supporting the overall GMP upstream and downstream manufacturing process, through the application of broad technical writing experiences, developing standard operating procedures for manufacturing processes as well as routine tasks in the production of bulk biologics therapies.

  • Generates/revises manufacturing batch records, both in the electronic batch record system (PAS-X) and the document management system
  • Generates/revises standard operating procedures and other related documents in clear and easy to understand language
  • May assist with management of change controls in the Quality Management System
  • Technical Writing Support of Upstream, Downstream and Central Services
  • Manage updates and revisions to technical process documentation
  • Interfaces across multiple departments with subject matter experts for review and approval of documentation and changes
  • Self-manages time to complete work based on critical timelines

Requirements:

  • Previous experience in Biotechnology/Pharmaceutical Manufacturing
  • Excellent written and verbal communication skills
  • Proficiency in MS Office, specifically MS Word and Visio
  • Strong attention to detail
  • Able to write in explanatory and procedural styles for multiple audiences
  • Skilled at prioritization and multi-tasking
  • Proven experience working in a technical writing position preferred
  • Experience with PAS-X/electronic batch records and change management preferred

Education:

  • BA preferred
  • Science degree (chemistry, biology, engineering, pharmacy) or experience in Life Sciences technical writing preferred.