About the Role:The Scientific Director, Pharmaceutical Development Analytics is a senior technical individual contributor and portfolio-level quantitative expert responsible for advancing data-driven drug product development across the CMC lifecycle. Embedded within Manufacturing, Science & Technology (MSAT), this role applies advanced statistics, experimental design, quantitative modeling, and mechanistic understanding to strengthen formulation and process development, process characterization, control strategies, and regulatory submissions.
The Scientific Director partners across Technical Operations, Quality, Regulatory CMC, Commercial Manufacturing, and Supply Chain to transform complex development and manufacturing data into actionable scientific insights that improve product performance, process robustness, and regulatory defensibility.
Your Contributions (include, but are not limited to):Scientific & Technical Leadership- Serve as the portfolio-level statistical and quantitative sciences expert supporting drug product development from post-Proof of Concept through commercialization
- Provide technical leadership across multiple CMC programs to strengthen process understanding, lifecycle knowledge management, and data-driven decision making
- Mentor scientists and promote best practices in statistical thinking, experimental design, and quantitative analysis
Development Analytics & Modeling- Design and apply advanced statistical methods, including Design of Experiments (DoE), multivariate analysis, response surface modeling, and process variability analysis
- Integrate development, analytical, and manufacturing data to identify critical material attributes (CMAs), critical process parameters (CPPs), process sensitivities, and design space
- Translate complex datasets into scientifically sound recommendations that improve formulation performance, manufacturability, and product quality
Formulation & Process Development- Partner with Pharmaceutical Development scientists to optimize formulations and manufacturing processes using data-driven and mechanistic approaches
- Support process characterization, scale-up, robustness assessments, risk analyses, troubleshooting, and root-cause investigations
- Guide development of robust control strategies by linking material attributes, process parameters, and product performance
Regulatory & Lifecycle Support- Serve as the quantitative lead supporting CMC regulatory submissions (IND, CTA, NDA, BLA, MAA) and lifecycle management activities
- Ensure statistical methodologies align with regulatory expectations and ICH guidelines (Q8, Q9, Q10, Q14)
- Support regulatory responses by providing clear, scientifically defensible interpretation of CMC data
Requirements:- Bachelor's degree in Chemical Engineering AND 12+ years of pharmaceutical industry experience, OR
- Master's degree in Chemical Engineering AND 10+ years of similar experience noted above OR
- PhD in in Chemical Engineering AND 8+ years of similar experience noted above OR
- Demonstrated expertise in DoE, multivariate analysis, process characterization, statistical modeling, and data visualization
- Working knowledge of solid oral dosage formulation and manufacturing processes (e.g., granulation, blending, compression, coating); hands-on development experience preferred
- Experience supporting late-stage development and global regulatory submissions
- Proficiency with JMP, R, Python, or comparable statistical software
- Excellent collaboration, communication, and technical influencing skills
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The annual base salary we reasonably expect to pay is $163,400.00-$223,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
