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.
Minimum Required Qualifications:
- B.S. degree in chemistry, engineering, or related scientific field with 4+ years of industry process chemistry experience. M.S. degree in chemistry, engineering, or related scientific field with 2+ years of industry process chemistry experience. PhD in chemistry, engineering, or related scientific field with 6 months+ of industry process 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 purification chromatography and scaling design.
- 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
Preferred Qualifications:
- 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, including risk assessments, design of experiments (DOEs), process performance evaluation, and late-stage CMC documentation practices.
Position is Full Time, Monday-Friday, 8am-5pm. Hybrid schedule with a minimum of three days per week onsite. Specific days onsite will be determined by business needs and subject to change. Candidates currently living within a commutable distance of Boston, MA are encouraged to apply.
Excellent full-time benefits include:
- Comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Eligibility for yearly goal-based bonus & merit-based increases
- Compensation: $40.00-$49.00 per hour
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.