Job Description
We are seeking a Senior Technical Writer to support manufacturing and quality investigations for a cell therapy manufacturing program preparing for clinical and commercial scale up. This role will focus on authoring high quality, inspection ready investigation documentation in a fast paced, regulated environment with minimal ramp up time. The ideal candidate brings strong GMP investigation writing experience, a solid understanding of manufacturing and/or QC processes, and the ability to translate complex technical inputs into clear, compliant documentation without extensive training or oversight.
This is a highly execution focused role supporting a time sensitive manufacturing program.
Key Responsibilities
Investigation Documentation & Writing
• Author, revise, and finalize manufacturing and quality investigation reports, including deviations, impact assessments, and related documentation
• Translate inputs from Manufacturing, Quality, MSAT, and QC into clear, defensible investigation narratives
• Ensure all documentation meets GMP, regulatory, and data integrity standards
• Maintain consistency, clarity, and compliance across investigations in a high volume environment
Manufacturing & Quality Support
• Support investigations related primarily to manufacturing and process deviations, with potential exposure to analytical/QC investigations
• Understand manufacturing workflows well enough to accurately reflect process events, timelines, and technical context in documentation
• Partner closely with Quality and Manufacturing teams to gather information efficiently and meet aggressive timelines
Execution & Speed
• Manage multiple investigations concurrently while maintaining quality and attention to detail
• Prioritize work based on manufacturing and batch release timelines
• Adapt quickly to evolving processes, templates, and systems
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
• 7–10+ years of experience in GMP regulated pharmaceutical or biotech manufacturing
• Demonstrated experience writing investigations (manufacturing deviations, OOS/OOT, CAPAs, impact assessments)
• Strong working knowledge of GMP documentation practices and regulatory expectations
• Ability to step into an investigation workflow with minimal training or hand holding
• Experience working in fast paced manufacturing environments with tight turnaround times
• Strong written communication skills — able to clearly articulate complex technical issues
Nice to Have Skills & Experience
• Experience supporting cell therapy, gene therapy, or biologics manufacturing
• Prior work in CAR T manufacturing environments
• Familiarity with electronic batch records, LIMS, and quality systems
• Experience supporting manufacturing investigations at CMOs or external manufacturing sites
• Background in both manufacturing focused and analytical/QC investigations
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.