Senior CMC Consultant

Job Summary

Serving as a strategic leader in Chemistry, Manufacturing, and Controls (CMC), the remote Senior CMC Consultant will provide technical guidance and hands-on execution for pharmaceutical and biotechnology clients throughout all phases of drug development, ensuring successful program delivery and high-quality outcomes.

Key responsibilities

• Act as a trusted CMC advisor, providing strategic guidance across all phases of product development
• Lead and manage CMC development activities for drug substances and drug products in alignment with program objectives and regulatory requirements
• Oversee CDMO/CMO selection, qualification, and ongoing management to support development and manufacturing activities

Required qualifications

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, Life Sciences, or a related scientific discipline required
• 15+ years of experience within the Pharmaceutical, Biopharmaceutical, Biotechnology, Cell and Gene Therapy industries
• Extensive expertise across the full CMC lifecycle, including drug substance and drug product development
• Demonstrated experience leading CMC strategy, technical operations, and regulatory support activities
• Experience managing CDMO/CMO relationships and external development and manufacturing partners