Senior Technical Writer

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 issuesJob DescriptionWe 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.Compensation:$45-50/hrExact compensation may vary based on several factors, including skills, experience, and education.Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k)-retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.