Senior Scientist / Associate Director, Drug Product Manufacturing

BridgeBio Pharma seeks a Senior Scientist or Associate Director to oversee commercial drug product manufacturing at contract manufacturing organizations. The role involves batch review, quality oversight, deviation management, and cross-functional collaboration in manufacturing science and controls.

Responsibilities

• Provide person-in-plant oversight of clinical and commercial drug product manufacturing at CMOs
• Review and release batches, participate in root-cause analysis and corrective action plans
• Participate in process confirmations, change controls, and quality oversight activities
• Coordinate investigations for out-of-specification results, deviations, and analytical anomalies
• Perform trend analysis and lead continuous improvement projects for commercial products

Requirements

• Bachelor's degree in life sciences, engineering, or related field
• Minimum eight years pharmaceutical industry experience
• cGMP regulations and quality oversight knowledge
• On-floor production support and cGMP experience required
• Quality management systems understanding
• Prior liaison experience with solid oral dosage form CMOs