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: Research Triangle Park (RTP), NC (Onsite)
Duration: 6 Months+ Possible Extension
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/Education:- 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
I
Integrated Resources, Inc