Senior Scientist / Associate Director, Drug Product Manufacturing
BridgeBio Pharma
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
Vacancy posted 7 days ago
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