Head of CMC

Summary:

This Biotech seeking a dynamic and experienced Head of CMC with a strong track record of developing small molecule programs. This pivotal role will oversee the development and implementation of CMC strategies to ensure the successful progression of our therapeutic candidates from discovery through clinical development and commercialization.

Key Responsibilities:

• Develop and execute CMC strategies for drug development programs.
• Oversee all aspects of drug substance and drug product manufacturing.
• Ensure compliance with regulatory requirements and industry standards.
• Manage relationships with external partners, including CMOs and CROs.
• Lead and mentor a team of CMC professionals.
• Collaborate with cross-functional teams to support project timelines and objectives.

Qualifications:

• Ph.D. in Chemistry, Chemical Engineering, or a related field.
• Minimum of 12 years of experience in CMC roles within the biotech or pharmaceutical industry.
• Proven track record of successful IND/IMPD/NDA submissions and regulatory interactions.
• Strong leadership and team management skills.
• Excellent communication and interpersonal abilities.