Technical Writer III

Job Description

Job Summary:

• As a member of Manufacturing Sciences, the Technical Writer will provide written documentation expertise to the clinical and commercial manufacturing campaigns run at the Parenteral Facility RTP Pharma Site.
• The focus of this position will be as a key leader for investigations and project implementation for Manufacturing Sciences using their technical expertise on fill/finish, visual inspection, and packaging.
• The incumbent will be tasked with writing PPQ Protocols, PPQ Reports, data verification activities for confirmation of source data for reports, preliminary writing for sections of the filing.
• Creating the Master Sample Matrix (MSM) for Manufacturing personnel to be used for on the production floor activities.

Qualifications:

• Life Science background with at least 5 years experience is preferred.
• Good communication and project management skills appropriate for leadership of tech transfer projects.
• Working knowledge in technical understanding of Parenteral Filling Operations (e.g. Filling Isolator, Lyophilizer, Visual Inspection) including transfer of such processes into full-scale drug product manufacturing facilities.
• Excels at working in a team environment.
• Comfortable analyzing scientific datasets/analytical skills with excellent written skills.
• Ability to work independently and support a large cross-functional group.
• Some knowledge of cGMP, FDA/EMA regulations, Process Performance Qualification, Continued Process Verification.