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🥝 Analytical SME & CMC Technical Writer

System One | Ridgefield, United States | Posted June 04, 2026

Job Description

Job Title: Analytical SME & CMC Technical Writer
Type: Contract
Compensation: $45-$53.33/hr
Contractor Work Model: Remote – offsite
Hours: 40.0


Overview
Leading pharmaceutical company looking for an experienced Analytical SME & CMC Technical Writer. Ideal candidates should have a minimum 6 years of experience in pharmaceutical or biotechnology CMC and analytical development for NCE and NCE-like drug substances and solid/liquid formulations


Responsibilities


+ Provide scientific leadership for phase-appropriate DS/DP analytical development and quality control activities, including method development, validation, transfer, and lifecycle management

+ Contribute to development of analytical specifications and control strategies for drug substance and drug product in collaboration with internal teams and external partners

+ Support DS/DP stability program design, data interpretation, and assignment of retest per...

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