Similar Jobs
See allAssociate Director, Technical Operations CMC Strategy
Travere Therapeutics
US
Small Molecule Development
Regulatory Submissions
Senior Manager/Associate Director, CMC Regulatory Affairs
Erasca
US
Regulatory Affairs
CMC
Oncology
Director, CMC Regulatory Affairs
Recursion
UK
Regulatory Affairs
CMC
Small Molecule Development
Director, Regulatory Affairs, CMC
BrainChild Bio
US
Cell Therapy
FDA Regulations
GMP
Senior Manager or Associate Director, CMC Project Management
WuXi
US
Project Management
MS Project
Small Molecule Development
Company Overview:
- We accelerate breakthrough science and delivery of life-enhancing therapies through our expertise, insight, consulting and management skills.
- We were recently honored with BioSpace's 'Best Places to Work' 2026 award, fostering a positive and engaging work environment.
Position Overview:
- We are seeking an experienced Senior Consultant to serve as a strategic CMC leader supporting pharmaceutical and biotechnology clients.
- The ideal candidate will possess extensive experience in drug substance and drug product development, regulatory strategy, and technical operations.
Key Responsibilities:
- Serve as a trusted CMC advisor to clients, providing strategic guidance across all phases of product development.
- Lead and manage CMC development activities for drug substances and drug products.
- Oversee CDMO/CMO selection, qualification, contracting, and ongoing management.
Qualifications:
- Bachelor's degree in a related scientific discipline required; advanced degree preferred.
- 15+ years of experience in Pharmaceutical, Biopharmaceutical, or Cell and Gene Therapy industries.
Syner-G
We accelerate breakthrough science and delivery of life-enhancing therapies through our expertise, insight, consulting and management skills. We were recently honored with BioSpace's 'Best Places to Work' 2026 award, fostering a positive and engaging work environment with emphasis on culture, career growth, and development.