13 дней назад
CMC Technical Writer (Synthetic Chemistry)
40 - 49$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
CMC Technical Writer (Synthetic Chemistry) (Process Chemistry/CMC): Developing conclusion-driven process characterization reports and regulatory-ready documentation for late-stage lipid technical transfer and novel gene editing products with an accent on synthetic chemistry, scientific data interpretation, and cGMP standards. Focus on translating experimental data into inspection-ready narratives, structuring process knowledge, and reducing SME review cycles.
Location: Boston, Massachusetts, USA; hybrid schedule with a minimum of three days per week onsite. Candidates must be within commuting distance of Boston and able to work in the United States indefinitely without sponsorship or restriction.
Salary: $40.00–$49.00 per hour
Company
provides analytical testing, laboratory, pharmaceutical, agroscience, and life sciences services across multiple industries.
What you will do
- Draft conclusion-driven process development reports from protocol objectives and limited subject-matter expert input.
- Translate CDMO findings, observations, outcomes, and raw experimental data into clear scientific narratives, tables, figures, and summaries.
- Structure reports according to internal templates and late-stage CMC documentation standards.
- Maintain traceable, inspection-ready source documentation for regulatory submissions and process knowledge management.
- Collaborate with process development functions to improve documentation practices and align reporting approaches across programs.
Requirements
- Bachelor’s degree with 4+ years, master’s degree with 2+ years, or PhD with 6+ months of industry process chemistry and/or synthetic chemistry experience.
- Professional fluency in English and strong written and verbal communication skills.
- Knowledge of cGMP documentation standards, 21 CFR Part 211, and relevant ICH Q guidelines.
- Experience with process characterization, process chemistry, process development, and organic synthesis.
- Proficiency in Microsoft Word and Excel, plus experience with an EDMS platform such as Veeva Vault or Documentum.
- Ability to work indefinitely in the United States without sponsorship or restriction.
Nice to have
- RNA-LNP process chemistry, process development, or process characterization experience.
- Familiarity with risk assessments, design of experiments, process performance evaluation, and late-stage CMC documentation.
Culture & Benefits
- Hybrid Monday–Friday schedule, generally 8:00 a.m.–5:00 p.m., with onsite days determined by business needs.
- Medical, dental, and vision coverage.
- Life and disability insurance.
- 401(k) with company match.
- Paid vacation and holidays, plus eligibility for annual bonuses and merit-based increases.
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