Назад
Company hidden
13 дней назад

CMC Technical Writer (Synthetic Chemistry)

40 - 49$
Формат работы
hybrid
Тип работы
fulltime
Грейд
middle
Английский
c1
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

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

hirify.global 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.

Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →