Sr. Manager/Associate Director, Drug Product

Role Summary

Sr. Manager/Associate Director, Drug Product. Responsible for the oversight of commercial drug product manufacturing at contract manufacturing organizations and facilitating global commercial drug product disposition. Acts as a technical liaison between the company and CMOs, collaborating with CMC, Supply Chain Operations, Quality Assurance, and CMC-regulatory Affairs.

Responsibilities

• Person-in-plant oversight of the commercial drug product manufacturing process at CMOs (especially for small molecule solid oral dosage forms)
• Perform activities related to batch review and release
• Participate and provide input to root-cause analysis and CAPA plans
• Participate in process confirmations, change controls, and quality oversight
• Coordinate investigations at external sites related to OOS/OOT, deviations, and unexpected analytical results
• Perform trend analysis of testing and process data for commercial drug products and participate in continuous improvement projects
• Generate batch genealogy for commercial materials

Qualifications

• BA/BS degree in Life Sciences, Engineering, or related field required
• Minimum of eight (8) years of experience within the pharmaceutical industry required
• Solid understanding of CMC manufacturing and analytical activities required in commercial drug product manufacturing, including knowledge of cGMP regulations
• Experience with cGMP quality oversight and on-floor production support required
• An understanding of Quality Management Systems is required
• Prior experience as a liaison with solid oral dosage form contract manufacturing organizations is required
• Ability to periodically travel within the EU and to the United States (up to 40% at times)

Skills

• Technical liaison between internal teams and contract manufacturers
• Strong knowledge of cGMP and regulatory expectations for commercial drug product manufacturing
• Quality oversight and problem-solving capabilities
• Data analysis and continuous improvement mindset

Education

• BA/BS in Life Sciences, Engineering, or related field

Additional Requirements

• Hybrid work model with in-office collaboration 2‚Äì3x per week in San Francisco