CMC Technical Writer (Contract)

Centessa Pharmaceuticals • Boston, MA

7d • Remote

About The Position

Centessa Pharmaceuticals, a clinical-stage company developing orexin receptor 2 (OX2R) agonists for narcolepsy and other sleep-wake disorders, is seeking a CMC Technical Writer. This role will involve critically reviewing 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 writer will also be responsible for creating scientific and regulatory content, authoring report summaries, and conclusions for the final document repository.

Requirements

• 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

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.

Benefits

• Medical plans, including PPO and EPO options
• Dental coverage
• Vision coverage
• 401(k)
• Wellness programs
• Other discounts

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed