Analysis Skills, Biology, Biotech and Pharmaceutical, Campaigns, Communication Skills, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Sets, Documentation, Drug Manufacturing, Drug Products, FDA Requirements, Leadership, Manufacturing, Project/Program Management, Realtime Transport Protocol, Team Player, Technical Writing, Writing Skills
Research Triangle Park, NC
Location: RTP Campus, NC 27709
Duration: 06 Months
Job Description:
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 of 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, and Continued Process Verification.e
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