CMC Technical Writer - Synthetic Chemistry

Company Description

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

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, 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.

• 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.

• B.S. degree in chemistry, engineering, or related scientific field with 4+ years of industry process chemistry and/or synthetic chemistry experience. M.S. degree in chemistry, engineering, or related scientific field with 2+ years of industry process chemistry and/or synthetic chemistry experience. PhD in chemistry, engineering, or related scientific field with 6 months+ of industry process chemistry and/or synthetic chemistry experience.

• Strong written and verbal communication skills, with professional fluency in English.

• Working knowledge of cGMP documentation standards, 21 CFR Part 211, and ICH Q guidelines relevant to process development and manufacturing.

• Proficiency in MS Word, Excel; experience with at least one EDMS platform (Veeva Vault, Documentum, or similar).

• Experience in process characterization, process chemistry, and process development including organic synthesis

• Strong foundation in compliance expectations for late-stage characterization work.

• Attention to detail, critical analysis of data/reports, and troubleshooting abilities.

• Proven ability to take initiative to achieve results, keep projects on timeline, and find solutions as needed to ensure that project deliverables are met.

• Excellent interpersonal communication skills and previously demonstrated the ability to interact within a multi-disciplinary team.

• Ability to meet deliverables with little supervision, manage priorities independently, highly organized, and self-motivated.

• Ability to work in the United States indefinitely without sponsorship or restriction

• Experience in RNA-LNP process chemistry and process development is preferred.

• Experience with RNA-LNP process characterization is highly desirable.

• Familiarity with process characterization activities,…