Director of CMC Quality Operations

Job Summary

Seeking a highly self-motivated Director of CMC Quality Operations, the remote position will manage analytical development, QA/QC, and stability activities at contract manufacturing sites while collaborating with various departments to support the development of clinical assets and regulatory submissions.

Key Responsibilities

• Manage contract drug substance and drug product analytical development and quality control activities and timelines
• Review analytical method transfer documentation and validation protocols/reports
• Collaborate with Quality Assurance to close investigations and deviations while managing reference standards and critical reagents programs

Required Qualifications

• At least 12 years of experience in Analytical Development and/or Quality Control in a pharmaceutical setting
• Familiarity with CMC analytical regulatory requirements and authoring of IND/IMPD/BLA/NDA/MAA filings
• Independently proficient in various analytical techniques for biologic and small molecule development
• Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices
• Proficient with enterprise quality management systems such as Veeva Vault, TrackWise, and LIMS