Develop and revise method transfer protocols, qualification protocols, reports, and associated technical documentation Support the drafting and revision of analytical methods and related QC documentation Develop and update SOPs and other controlled documents, with a high volume of SOP writing and revision expected Support documentation required for BLA and regulatory submissions, including translating complex analytical information into clear, scientifically accurate written content Review analytical data, laboratory documentation, and technical source materials to support accurate reports and other QC deliverables Draft and revise reports using established templates, including periodic and quarterly reports Collaborate directly with QC scientists and SMEs to understand analytical activities, resolve gaps or inconsistencies, and ensure technical accuracy Support analytical method transfers and technology transfer activities, including documentation required for transfer readiness Assist with documentation packages supporting method validation, qualification, PPQ readiness, and overall QC operational readiness Ensure documentation is scientifically accurate, clear, consistent, and aligned with GMP, data integrity, and internal quality requirements Manage document lifecycle activities including formatting, review coordination, revisions, version control, and incorporation of SME feedback Work closely with the QC team onsite to facilitate efficient communication, obtain technical input, and reduce the documentation burden on QC scientists Identify missing or unclear technical information and proactively work with SMEs to obtain the information needed to complete high-quality documentation Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements. Author, revise, and finalize technical documentation supporting QC Chemistry and QC Microbiology, including method transfer, qualification, validation, and readiness activities.