What are the responsibilities and job description for the Sr. Scientific Writer Job at Forge Biologics Inc. in Columbus position at Forge Biologics Inc.?
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
Work Environment and Physical Demands
This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing / sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.
Life at Forge
We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry.
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