CMC Technical Writer - Synthetic Chemistry

Eurofins; Boston (MA); On-site; USD 83,000 - 102,000; Full time

Benefits offered by this job

Medical coverage

Dental and vision options

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA PSS is hiring a CMC Technical Writer to join the Synthetic Chemistry team in a hybrid role based near Boston, MA. The role focuses on translating complex process development data into clear, inspection-ready documentation that supports regulatory submissions and lifecycle management.

The ideal candidate brings a strong chemistry background, 4+ years of industry experience, and proficiency with cGMP documentation standards.

Qualifications

• BS in chemistry/engineering with 4+ years of industry process chemistry or synthetic chemistry experience; MS with 2+ years; PhD with 6 months+ experience.
• Strong written and verbal English communication.
• Working knowledge of cGMP, 21 CFR Part 211, and ICH guidelines relevant to process development and manufacturing.
• Proficiency in MS Word and Excel; experience with at least one EDMS platform.
• Experience in process characterization, process chemistry, and organic synthesis.

Responsibilities

• Draft conclusion-driven process development reports from objectives and SME input.
• Structure reports per internal templates and late-stage CMC standards.
• Transform raw data into tables, figures, and summaries.
• Produce first drafts with minimal SME revision.
• Maintain traceable, inspection-ready documentation for regulatory submissions.
• Collaborate across process development to align reporting and work packages.

Skills

Communication skills

Attention to detail

Organization

Self-motivation

Time management

Education

Bachelor's or higher in chemistry

MS in chemistry or related field

PhD in chemistry or related field

Tools

MS Word

MS Excel

EDMS (Veeva Vault or Documentum)

Job description

CMC Technical Writer - Synthetic Chemistry

• Full-time
• Compensation: USD 40 - USD 49 - hourly

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.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

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.

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 and/or synthetic chemistryexperience. 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

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.