Peptide Development Technical Manager

Job Summary

A company is looking for a CMC Technical Manager, Peptide Development.

Key Responsibilities

• Oversee peptide programs at CDMO and ensure timely completion of activities for peptide-based radiopharmaceuticals
• Review and approve master batch records, method validation protocols, and specifications for clinical and commercial peptide products
• Manage technical and quality aspects of clinical projects from raw materials to manufacturing and distribution

Required Qualifications

• Minimum B.S. degree in Chemistry, Biochemistry, or a related field
• 7+ years of experience in the Pharmaceutical Industry in a similar role
• Prior experience with peptide synthesis, purification, and lyophilization
• Experience working with CMC peptide programs in regulatory settings with external collaborators/vendors
• Familiarity with regulatory and quality assurance aspects in peptide manufacturing processes