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Role The Technical Writer position will support Manufacturing in the creation and/or revision of Procedures (SOPs), Batch Records (BRs), and Electronic Batch Records (EBRs) pertaining to Upstream, Downstream, and/or Solution Preparation process operations. This will include working with Manufacturing Subject Matter Experts to ensure document accuracy and detail. The Technical Writer will be responsible for initiation and management of document workflows to ensure adherence to deadlines and coordinating document changes for identified Corrective and Preventive Actions. This position involves interaction with cross-functional departments within Client Technical Operations. The Technical Writer is responsible for ensuring compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies, and safety practices. Client'sTechnical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These individuals build and maintain Client's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Key Responsibilities Write and revise cGMP documentation (Standard Operating Procedures, Production Batch Records and/or Electronic Batch Records) and facilitate the review and approval of documents in a timely manner and within established timelines. Ensure documents are technically accurate and consistent with internal style guidelines for format, clarity, flow, organization, and readability. Manage work independently to ensure timely implementation of documentation workflows. Work with Manufacturing Management and QA Change Control to establish comprehensive implementation plans for document revisions and associated change requests. Interact with appropriate departments to establish priorities and deadlines for document revisions. Communicate with appropriate departments to ensure changes are understood and compliance with respect to changes is maintained. Other duties as assigned. Duration: Calendar Year of 2025 (initial contract duration is for 6-month) Clarifications and Assumptions 1. Work is assumed to require up to 40 hours per week, in support of the Client Novato campus. 2. The resource will be 50% dedicated to GE and 50% dedicated to GN (likely requires two proposals for the 1 resource. 3. The initial duration is for a 6-month contract. We will extend as needed from there. 4. Working remotely is an option, and the schedule will be determined in collaboration with Client