What are the responsibilities and job description for the Senior Analytical Development Scientist – CMC Technical Writing position at Astrix?
We are seeking an experienced Analytical Development professional with strong CMC technical writing expertise to support drug substance (DS) and drug product (DP) development programs within a leading pharmaceutical organization.
Location: REMOTE (Candidates must work East Coast hours)
Rate: $55-$59/hr
Contract (12 months)
Key Responsibilities
Location: REMOTE (Candidates must work East Coast hours)
Rate: $55-$59/hr
Contract (12 months)
Key Responsibilities
- Provide analytical leadership for method development, validation, transfer, and lifecycle management.
- Support development of specifications, analytical control strategies, and stability programs.
- Author, review, and edit CMC documentation, including CTD Module 3 content.
- Support regulatory submissions (IND, CTA, NDA, MAA) and health authority responses.
- Manage documentation workflows within Veeva RIM.
- Collaborate with internal teams and external manufacturing/testing partners to ensure timely project deliverables.
- Bachelor's degree required; Master's or PhD preferred in Analytical Chemistry, Pharmaceutical Sciences, or related field.
- 6 years of pharmaceutical/biotech experience in CMC and analytical development.
- Experience supporting regulatory submissions and technical writing activities.
- Knowledge of GMP and global regulatory guidelines (ICH, FDA, EMA, USP, EP).
- Experience with Veeva RIM strongly preferred.
Salary : $55 - $59