Scientific Director, Pharmaceutical Development Analytics

Scientific Director, Cmc Quantitative Sciences

The Scientific Director, Cmc Quantitative Sciences is a senior technical individual 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.

In addition to serving as a quantitative authority, this role actively supports formulation and process development strategy by integrating statistical and mechanistic understanding of product design (at first principles-level) to optimize formulations for performance, stability and manufacturability, and strengthen process robustness.

The Director partners cross-functionally with Pharmaceutical & Analytical Development, Quality, Regulatory Cmc, and Commercial Manufacturing & Supply Chain to ensure that 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, strengthening process understanding, enabling robust control strategies, and improving the quality and regulatory defensibility of Cmc submissions.

While embedded in Pharmaceutical Development, the position influences programs spanning late-stage development through commercial lifecycle management and serves as a technical authority and mentor for quantitative approaches across Cmc functions.

Requirements:

• 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

This role does not:

• Directly manage or formally supervise staff
• Own routine manufacturing execution or site-level operational performance
• Serve as program Cmc functional area lead, make final operational, business, or budgetary decisions for Cmc programs
• Manage headcount, administrative processes, or team performance evaluations
• Replace hands-on experimental or process work performed by development teams