ABOUT VGXI INC

VGXI is a leading-edge CDMO dedicated to revolutionizing the biopharmaceutical industry with best-in-class nucleic acid-based products and services. We deliver manufacturing excellence in state-of-the-art facilities with the agility and scale to meet projects of all sizes to serve the global community of next-generation therapeutic developers.
If you are driven by innovation, fueled by scientific curiosity, and committed to making a positive impact on the global pharmaceutical community, you’ve come to the right place. We are always looking for quality-minded, team-oriented individuals who share our dedication to excellence. At VGXI, we’ve cultivated a workplace that people genuinely enjoy being a part of, and we take immense pride in the role they play in shaping our success story. We embrace a culture of quality in our products and in our people. Explore the possibilities, unlock your potential, and contribute to the future of Plasmid DNA manufacturing and precision medicine with VGXI.

SUMMARY

The Technical Writer will be responsible for authoring and reviewing event reports (i.e. deviations, investigations, Corrective Action Prevention Action (CAPAs), OOS) as well as completing any resulting document change orders. The Technical Writer also authors and reviews documents related to the technology transfer of production processes into GMP production.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Write and communicate in a clear and concise manner.
• Use critical thinking to analyze and identify event report root cause.
• Responsible for author and reviewer follow up for completion of event reports within due dates.
• Collaborate effectively across departments in a team environment.
• Responsible for writing and reviewing documents involved in technology transfer of production processes into GMP production in collaboration with VGXI’s client, PD, MFG, QC and QA.
• Perform detailed review of client’s and PD processes. Includes authoring and reviewing technology transfer protocols and summaries.
• Author and review process flow diagrams, batch records, and campaign summary reports.
• Ensure consistency across documents and improve document quality.
• Organize and manage data/analyses of various operational parameters.

EDUCATION AND/OR EXPERIENCE

Bachelor’s degree in biology, biotechnology, molecular biology, biochemistry, chemistry, or closely related field with two or more years in GMP Manufacturing, Quality Assurance or Quality Control. Demonstrable technical writing skills are highly preferred.

• Write and communicate in a clear and concise manner.
• Use critical thinking to analyze and identify event report root cause.
• Responsible for author and reviewer follow up for completion of event reports within due dates.
• Collaborate effectively across departments in a team environment.
• Responsible for writing and reviewing documents involved in technology transfer of production processes into GMP production in collaboration with VGXI’s client, PD, MFG, QC and QA.
• Perform detailed review of client’s and PD processes. Includes authoring and reviewing technology transfer protocols and summaries.
• Author and review process flow diagrams, batch records, and campaign summary reports.
• Ensure consistency across documents and improve document quality.
• Organize and manage data/analyses of various operational parameters