Scientific Director, Pharmaceutical Development Analytics

About the role

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.

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.

Responsibilities

• Owns drug product design and development strategy
• Generates, maintains and leverages process understanding and development data
• Informs control strategy for regulatory submission and hands-off to commercial
• Supports formulation and process development strategies through data-driven insights and mechanistic interpretation
• Serves as a technical authority for statistical interpretation across lifecycle stages
• Supports troubleshooting efforts and root-cause investigations as needed on both the formulation and process development fronts for development and commercial assets
• Complex Data Interpretation
• Apply multivariate tools to support identification of CMAs, CPPs, and design space boundaries
• Serve as a technical authority for complex data interpretation across CMC programs
• Provide statistical guidance for investigations involving process variability
• Support root cause analysis of complex development or manufacturing trends
• Integrate datasets across development, analytical, and manufacturing functions to generate actionable insight
• Translate experimental data into formulation and process understanding, including identification of critical material attributes, excipient functionality, and process sensitivities
• Support development teams in interpreting DoE outcomes to refine formulations and unit operations (e.g., granulation, blending, compression, coating)
• Formulation & Process Development Support
• Partner with Pharmaceutical Development scientists to design and optimize formulations using structured experimental approaches (DoE, mixture designs, response surface methods)
• Provide quantitative and mechanistic input into selection of excipients, formulation composition, and process parameters
• Support development and scale-up of key unit operations (e.g., fluid bed granulation, roller compaction, blending, tableting, coating) through data-driven modeling and risk assessment
• Guide process characterization strategies, including definition of parameter ranges, interaction effects, and scale dependencies
• Contribute to development of robust manufacturing processes by linking material attributes, process parameters, and product performance
• Support assessment of formulation and process robustness, including sensitivity analyses and failure mode identification
• Regulatory Submission Support
• Serve as a primary statistical authority supporting CMC regulatory submissions (NDA, BLA, MAA)
• Ensure statistical methodologies used in development and validation are regulatory defensible and aligned with ICH guidelines (Q8, Q9, Q10, Q14)
• Provide statistical interpretation for process validation strategies and control strategy justification
• Support responses to regulatory questions related to CMC data analysis and statistical methodology
• Contribute to justification of formulation composition, process design, and design space within regulatory filings
• Capability Building
• Strengthen quantitative capabilities across Pharmaceutical Development
• Drive adoption of modern data science and modeling approaches that improve development efficiency and process understanding
• Establish best practices for experimental design and statistical analysis in development programs
• Mentor scientists on statistical thinking and interpretation of experimental results
• Promote integration of statistical and formulation/process science to enable more predictive and efficient development approaches

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

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

Skills

• Advanced statistical analysis and modeling expertise
• Translation of complex development and manufacturing data into actionable technical insights
• Ensuring statistical rigor and regulatory defensibility of CMC data packages
• Supporting formulation and process development strategies through data-driven insights and mechanistic interpretation
• Supporting troubleshooting efforts and root-cause investigations as needed on both the formulation and process development fronts for development and commercial assets
• Complex data interpretation
• Application of multivariate tools to support identification of CMAs, CPPs, and design space boundaries
• Statistical guidance for investigations involving process variability
• Supporting root cause analysis of complex development or manufacturing trends
• Integration of datasets across development, analytical, and manufacturing functions to generate actionable insight
• Translation of experimental data into formulation and process understanding, including identification of critical material attributes, excipient functionality, and process sensitivities
• Supporting development teams in interpreting DoE outcomes to refine formulations and unit operations (e.g., granulation, blending, compression, coating)
• Partnering with Pharmaceutical Development scientists to design and optimize formulations using structured experimental approaches (DoE, mixture designs, response surface methods)
• Providing quantitative and mechanistic input into selection of excipients, formulation composition, and process parameters
• Supporting development and scale-up of key unit operations (e.g., fluid bed granulation, roller compaction, blending, tableting, coating) through data-driven modeling and risk assessment
• Guiding process characterization strategies, including definition of parameter ranges, interaction effects, and scale dependencies
• Contributing to development of robust manufacturing processes by linking material attributes, process parameters, and product performance
• Supporting assessment of formulation and process robustness, including sensitivity analyses and failure mode identification
• Supporting regulatory submissions (NDA, BLA, MAA) with defensible statistical methodology
• Integrating datasets across development, analytical, and manufacturing functions for program-level insight
• Providing advanced statistical analysis, modeling, and interpretation across CMC development programs
• Translating complex development, analytical, and manufacturing data into actionable technical insights
• Ensuring statistical rigor and regulatory defensibility of CMC data packages and submissions
• Promoting adoption of modern data science and modeling approaches to improve efficiency and process understanding

Benefits

• Annual base salary: $0.00-$0.00
• Annual bonus with a target of 35% of the earned base salary
• Eligibility to participate in our equity-based long-term incentive program
• Retirement savings plan (with company match)
• Paid vacation, holiday, and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans