Analytical Scientist / CMC Scientist

REMOTE | Analytical SME & CMC Technical Writer | 12-Month Contract | Pharmaceutical IndustryWe are seeking an experienced Analytical SME & CMC Technical Writer to support drug substance (DS) and drug product (DP) development programs within a fast-paced pharmaceutical environment.This role is ideal for someone with a strong background in analytical development, CMC documentation, regulatory submissions, and technical writing within biotech/pharma.Key Responsibilities:• Support DS/DP analytical development, QC, stability programs, and control strategies• Author/review CTD Module 3 documentation and analytical sections for global regulatory submissions• Collaborate with internal teams and external CDMOs/CROs• Review protocols, reports, specifications, quality agreements, and stability data• Manage documentation workflows within Veeva RIMRequired Qualifications:• PhD required• 6+ years of pharmaceutical/biotech CMC and analytical development experience• Strong experience with regulatory submissions and technical writing• Familiarity with GMP and global regulatory guidelines (ICH, FDA, EMA, USP, EP)• Experience supporting solid and liquid formulationsPreferred:• Experience with IND, CTA, NDA, or MAA submissions• Experience working with external manufacturing/testing partnersTop Skills:• Analytical development & QC expertise• CMC technical writing and regulatory documentation• Strong communication and cross-functional collaborationAdditional Details:• Fully Remote• 12-month contract• Interview process includes video interview + panel interviewInterested candidates are encouraged to apply with an updated resume.