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CMC Technical Writer (Contract)
Centessa Pharmaceuticals
Remote, USA
Contract, Temporary
Senior · 12+ years experience
Remote
USD 120-140 hourly / hour
Discovered Yesterday
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Description of Role
The CMC Technical Writer role will critically review data, methods, batch records, and various development, campaign, and production reports from external CDMOs to finalize source documents for analytical, drug substance and drug product. The CMC Technical Writer should also then be able to write scientific and regulatory content and author and prepare report summaries and conclusions from the source documents for final document repository.
Key Responsibilities
- Translate data, parameters, and results from various CDMOs in various disciplines (analytical, drug substance, drug product) into scientific reports with appropriate scientific summaries and conclusions to support regulatory content and submissions.
- Review, revise, and finalize technical reports from CDMOs in support of program deliverables.
- Assist with document finalization and final source document organization, including but not limited to analytical methods, validation reports, method development summaries, batch records, and campaign/production reports.
- Partner with Quality on specification and retest/expiry/shelf-life documentation, as well as close coordination with Clinical Supply for investigational medicinal product documentation and alignment with Regulatory on documents for modules and submissions.
Qualifications
- 12+ years of pharmaceutical or biotechnology industry experience with broad CMC expertise across Drug Substance, Drug Product, Analytical Development, and Regulatory CMC.
- Scientific background with strong technical writing and communication skills
- Understanding of phase-appropriate documentation to support CMC development, including regulatory guidelines and filing requirements
- Ability to simplify complex scientific terminology into high-level take home narratives for ease of review
- Proficient with document management tools
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