As a CMC Technical Writer, you will have an integral role in Late-Stage Lipids Technical Transfer and Process Chemistry supporting novel gene editing products. The successful candidate will possess a solid understanding of small molecule synthesis and purification processes, enabling effective engagement with project teams and the translation of technical progress into clear, concise, and scientifically rigorous documentation. The documentation will serve as a critical foundation for late-stage process characterization and regulatory readiness. The successful candidate will be responsible for driving the documentation and scientific narrative of process characterization efforts in parallel with the process SMEs. Their ability to independently develop high-quality, conclusion-driven reports and capture process knowledge in a structured manner will meaningfully expedite development timelines, improve documentation efficiency, and contribute significantly to overall project success.
Key Responsibilities:
- Independently draft conclusion-driven process development reports from protocol objectives and minimal SME input, translating key findings, observations, and outcomes generated by CDMOs into clear scientific narratives.
- Develop and structure reports in alignment with internal templates and late-stage CMC documentation standards, incorporating appropriate scientific rationale, data presentation, references, and well-supported conclusions.
- Transform raw experimental data (in-process controls, yield/purity results, scale comparisons, and equipment parameters) into coherent tables, figures, and summaries without requiring process SME to pre-develop the report storyline.
- Produce substantively complete first drafts that require minimal SME revision, reducing review cycles and enabling efficient documentation of development activities.
- Maintain traceable and inspection-ready source documentation to support regulatory submissions, process knowledge management, and lifecycle documentation requirements.
- Collaborate across broader process development functions to establish best Documentation practices, support process characterization initiatives, and align reporting approaches and work packages across diverse modalities and programs.