Senior Director, Drug Substance Development

Kardigan is seeking a Senior Director, Drug Substance Development to support the development of a large late-phase portfolio. The role will report directly to the VP of DS Development and be responsible for API development, chemical route optimization, process development, manufacture, and supply of drug substance.

Requirements

• S, MS or PhD in chemistry, chemical engineering, or related discipline.
• Minimum 15 years' experience within pharmaceutical CMC development and Technical Operations.
• Sound knowledge of chemical development, process engineering and/or plant operations.
• Demonstrated experience with drug substance process development, scale-up, technology transfer, and optimization from R&D through commercialization.
• Significant experience in working with global health authorities, IND, IMPD, NDA, MAA etc
• Experience with process validation and continuous process improvement.
• Ideally experience with commercializing small molecules and oligonucleotide drug products
• Extensive knowledge of regulated manufacturing, GMP, GCP and quality systems.

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance