Sr. Scientific Writer

About Forge 

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.   

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.  

About The Role  

This position supports the Quality Control department in developing clear, accurate, and well-organized technical documentation. Working cross-functionally, this role will produce critical documents, ensure formatting consistency, and assist in refining content for ease of understanding and compliance with GxP standards. The ideal candidate thrives in a collaborative, compliance-focused environment and has the attention to detail necessary for quality documentation in a CDMO setting.

What You'll Do  

• Draft, review, and update product documentation such as sampling plans, specifications, COAs, COTs, stability protocols, and reports
• Write and edit methods, SOPs, qualifications, validations, and tech transfer documentation using clear, plain language
• Organize and streamline procedures and forms for improved usability and comprehension
• Collaborate closely with QC, QA, and SMEs across all departments to stay informed of laboratory processes and technologies
• Ensure consistent formatting, structure, and style across various documents and documentation types
• Lead projects independently to ensure that material is complete and accurate:
  • Maintain a comprehensive project list to ensure timely completion
  • Translate complex technical information from SMEs into clear, well-organized content
  • Identify redundancies, gaps, and inconsistencies in documents, consulting with relevant SMEs to resolve
  • Communicate with clients as needed to verify and clarify information
  • Aide in training analysts in updates to the documents and procedures, such as creating slides and other written tools as needed
  • Track documentation throughout its lifecycle stages, from initial drafts through final approvals
• Maintain a quality-driven approach in aligning documentation with regulatory standards and audit requirements
• Conduct periodic reviews to identify improvements and standardization opportunities in documentation practices
• Provide expertise in technical writing best practices and mentor junior team members as needed

What You'll Bring

• 2-3 years experience in a GxP lab environment, or advanced degree in a relevant scientific field
• Demonstrated expertise in technical writing, copy-editing, and document formatting
• Strong written and verbal communication skills, with the ability to engage with technical and non-technical stakeholders
• Skilled in translating scientific and technical information into clear, concise, and compliant documentation, ensuring alignment with regulatory standards and internal quality requirements
• Experience teaching and/or training scientific material and processes
• Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems
• Experience with biopharmaceutical testing, laboratory procedures, and drafting and following written testing methods
• Self-driven and proactive, with a strong ability to work independently while effectively collaborating with cross-functional teams in a fast-paced setting
• Proven ability to manage multiple priorities in a dynamic environment, adapting quickly to evolving project needs and timelines
• Exceptional organizational and time-management skills to efficiently prioritize tasks, balancin