Job Description

Job Responsibilities:

• 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.

Skills:

• 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.

Education/Experience:

• Life Science background with at least 5 years experience is preferred.

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