Scientific Director, Pharmaceutical Development Analytics
On-site · San Diego, California, United States
Job Summary
The Scientific Director, CMC Quantitative Sciences is a senior technical contributor responsible for designing and advancing data-driven development and lifecycle management initiatives for drug products, including knowledge management, through application of advanced statistical analysis, experimental design, and quantitative modeling. Embedded within Pharmaceutical Development, this role serves as the portfolio-level statistical authority supporting drug product development programs from post-Proof of Concept through regulatory submission and the commercial lifecycle. It actively supports formulation and process development strategy by integrating statistical and mechanistic understanding of product design to optimize formulations for performance, stability and manufacturability, and strengthen process robustness. The Director partners cross-functionally to ensure development and manufacturing decisions are supported by rigorous statistical analysis and defensible interpretation of CMC data. This role provides technical leadership across multiple development programs, mentoring scientists and strengthening quantitative capabilities within Pharmaceutical Development, and influencing formulation and process development decisions through data-driven and mechanistic insights. It supports regulatory submissions with defensible statistical methodology, integrates datasets across development, analytical, and manufacturing functions for program-level insight, and translates complex data into actionable technical insights while ensuring regulatory defensibility of CMC data packages and submissions.
Required Qualifications
- PhD, PharmD, or MS in Statistics, Chemical Engineering, Pharmaceutical Sciences, or related quantitative discipline
- 12-15+ years of experience applying statistical analysis to pharmaceutical development or manufacturing at all stages of development
- Demonstrated expertise in: Design of Experiments (DoE), multivariate analysis, process capability and variability analysis, statistical modeling of manufacturing processes
- Working knowledge of formulation principles and solid oral dosage formulation and unit operations (e.g., granulation, blending, encapsulation, compression, coating) required. Hands-on experience is strongly preferred
- Experience supporting late-stage development and regulatory submissions (IND/IMPD/CTA/NDA/BLA/MAA)
- Proficiency with analytical platforms such as JMP, R, Python, or equivalent statistical tools
- Strong ability to influence cross-functional teams through technical expertise and data interpretation
- Act as a portfolio-level technical authority for quantitative approaches throughout the drug product lifecycle
- Mentor scientists and strengthen quantitative capabilities within Pharmaceutical Development
- Guide experimental design, process characterization, and control strategy development
- Actively influence formulation and process development decisions through data-driven and mechanistic insights
- Support regulatory submissions (NDA, BLA, MAA) with defensible statistical methodology
- Integrate datasets across development, analytical, and manufacturing functions for program-level insight
- Provide advanced statistical analysis, modeling, and interpretation across CMC development programs
- Translate complex development, analytical, and manufacturing data into actionable technical insights
- Ensure statistical rigor and regulatory defensibility of CMC data packages and submissions
- Promote adoption of modern data science and modeling approaches to improve efficiency and process understanding
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