CMC Technical Writer - Tech Transfer & Process Chemistry (Process Chemistry)

Location: Hybrid in Boston, MA, USA, with a minimum of three days per week onsite; candidates must be able to work in the United States indefinitely without sponsorship or restriction.

Salary: USD 40.00–49.00 per hour

Company

hirify.global Scientific is an international life sciences company providing analytical testing, laboratory, pharmaceutical, CDMO, and related scientific 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, including rationale, references, data presentation, and supported conclusions.
• Maintain traceable, inspection-ready source documentation for regulatory submissions, process knowledge management, and lifecycle documentation.
• Collaborate with process development functions to establish documentation practices and align reporting approaches across programs and modalities.
• Support late-stage lipid technical transfer and process chemistry activities for novel gene editing products.

Requirements

• B.S. degree in chemistry, engineering, or a related scientific field with 4+ years of industry process chemistry experience; or M.S. with 2+ years; or PhD with 6+ months.
• Professional fluency in English and the ability to work in the United States indefinitely without sponsorship or restriction.
• Working knowledge of cGMP documentation standards, 21 CFR Part 211, and relevant ICH Q guidelines.
• Experience in process characterization, process chemistry, process development, purification chromatography, and scale-up design.
• Proficiency in Microsoft Word and Excel, plus experience with an EDMS platform such as Veeva Vault or Documentum.
• Strong data analysis, troubleshooting, communication, organization, prioritization, and independent delivery skills.

Nice to have

• RNA-LNP process chemistry, process development, or process characterization experience.
• Experience with risk assessments, design of experiments, process performance evaluation, and late-stage CMC documentation.

Culture & Benefits

• Full-time Monday–Friday schedule, 8:00am–5:00pm.
• Hybrid work schedule 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, annual bonus eligibility, and merit-based increases.