CMC Technical Writer: Process Chemistry & Regulatory Docs

Eurofins PSS Insourcing Solutions

Boston (KY)

Hybrid

USD 114,616,000 - 140,405,000

Full time

14 days+

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Benefits offered by this job

Medical, dental, vision benefits

401(k) with company match

Paid vacation and holidays

Bonus potential

Job summary

Eurofins PSS Insourcing Solutions seeks a CMC Technical Writer to support late-stage Lipids technical transfer and process chemistry, translating experimental data into clear, publication-quality documents. You will work with project teams to drive documentation for regulatory readiness and lifecycle knowledge management.

The role emphasizes drafting high-quality reports, aligning with cGMP standards, and collaboration across programs. Hybrid schedule, Boston area, with onsite days.

Qualifications

BS degree in chemistry, engineering, or related field with 4+ years of industry process chemistry experience; MS with 2+ years; PhD with 6 months+.
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 EDMS platforms (Veeva Vault, Documentum, or similar).
Experience in process characterization, process chemistry, and process development including purification chromatography and scaling design.
Strong compliance foundations for late-stage characterization work.
Attention to detail, data analysis, troubleshooting abilities.
Ability to meet deliverables with minimal supervision, stay on timeline, and work independently.
Excellent interpersonal communication and ability to collaborate in a multi-disciplinary team.

Responsibilities

Independently draft conclusion-driven process development reports from protocol objectives and SME input.
Develop and structure reports per internal templates and late-stage CMC standards.
Transform raw data into tables, figures, and summaries without pre-developing the storyline.
Produce substantively complete first drafts with minimal SME revisions.
Maintain traceable, inspection-ready source documentation for regulatory submissions and knowledge management.
Collaborate across process development to standardize documentation practices and align reporting.

Skills

Strong written and verbal

English fluency

Attention to detail

Independent initiative

Team collaboration

Education

B.S. in chemistry/engineering

M.S. in chemistry/engineering

Ph.D. in chemistry/engineering

Tools

MS Word

Excel

EDMS (Veeva Vault / Documentum)

Job description

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.

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.

If you’re looking for a rewarding career, a place to call home, apply with us today!

Job Description

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.

Qualifications

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.

Additional Information

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