Director, Drug Substance Development

Kardigan is seeking an experienced Director of CMC Drug Substance Development to oversee the development of a growing early-stage pipeline and a complex late-stage portfolio across small molecules and oligonucleotides. The role will support the end-to-end API development and provide technical, strategic, and operational leadership across all internal and outsourced development and manufacturing activities.

Requirements

• BS and MS/PhD in Organic Chemistry, Chemical Engineering, or a related scientific discipline
• 10+ years of experience in the development of assets, spanning early- and late-stage development
• Expertise in small molecules and preferably oligonucleotide product development
• Experience in leading the development of mid Phase and late phase assets
• Strong knowledge of GMP, global regulatory expectations, and quality systems
• Direct experience with global regulatory submissions (IND, IMPD, NDA, MAA)
• Proven leadership in process validation and continuous improvement initiatives
• Excellent communication and presentation skills, with the ability to partner effectively and work within cross-functional teams
• Ability to operate with agility in a fast-paced, matrixed, growth-oriented environment
• Creative, solutions-focused mindset with a track record of driving operational progress and scientific excellence

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Health Insurance