Director CMC Drug Substance
Location: Remote
Compensation: Salary
Staff Reviewed: Thu, Jan 09, 2025
This job expires in: 25 days
Job Summary
A company is looking for a Director, CMC Drug Substance (Remote).
Key Responsibilities
- Direct CMC drug substance development and manufacturing activities, providing scientific and technical leadership
- Lead strategy, planning, execution, and progress reporting for development projects and commercial products
- Identify and manage relationships with external partners, ensuring compliance with health, safety, environmental, and quality requirements
Required Qualifications
- Bachelor's degree with 15 years, Master's degree with 12 years, or PhD with 8 years of relevant experience
- Ph.D. in organic chemistry or chemical engineering preferred, with at least 7 years of related technical experience in the pharmaceutical/biotech industry
- In-depth knowledge of synthetic route development, process optimization, and large-scale manufacturing of drug substances
- Experience with cGLP/cGMP requirements and authoring drug substance sections of regulatory submissions
- Proven director-level management experience with a focus on strategy development and team leadership
COMPLETE JOB DESCRIPTION
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