Associate Director, Drug Substance
Job Summary
To drive late-stage development and commercial manufacturing processes, the full-time Associate Director, Drug Substance will manage cross-functional collaborations, oversee technical transfers, and ensure regulatory compliance in a remote capacity.
Key responsibilities
- Design and optimize scalable drug substance processes in partnership with internal teams and external CDMOs
- Lead technical transfers and scale-up activities while ensuring compliance with FDA and EMA regulations
- Establish control strategies and support regulatory submissions by authoring CMC sections
Required qualifications
- Ph.D. or M.S. in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a closely related discipline
- 8+ years of experience in drug substance development and manufacturing within the pharmaceutical industry
- Strong background in managing CDMO relationships and outsourcing strategies
- Demonstrated experience in process development, scale-up, and technical transfer
- Knowledge of global regulatory requirements and cGMP compliance
Complete Job Description
The complete job description is available to members. Premium membership includes:
Full access to 41,975 remote jobs from human-vetted companies, updated daily
Resume Builder - AI-powered tool to craft, enhance, and tailor your resume to a specific job
Twice-monthly live group coaching and the full Remote Career Center
20% member discount on Career Services
Backed by a 30-day money-back guarantee
Company Company Name
Headquarters Headquarters
Founded Founded
Website
The company description is available to members. Go Premium for full access to every job and company profile in our remote jobs database, backed by a 30-day money-back guarantee.
