Senior CMC Modeling Leader – Tech Transfer & AI/ML

Merck; Boston (MA); Hybrid; USD 210,000 - 331,000; Full time

Job summary

Merck seeks a Distinguished Scientist to lead Brick 1 within CMC Lighthouse Pillar 2, Digitally Enabled Technology Transfer. You will define a unified modeling strategy across CMC domains and modalities to enable faster, more predictive technology transfer decisions across development, manufacturing and commercialization.

You will guide mechanistic, statistical, hybrid, empirical, and AI/ML models, manage lifecycle governance, and drive deployment, reuse, and capability building across programs

Qualifications

• Ph.D. in chemical engineering, chemistry, biochemistry, pharmaceutical sciences, systems engineering, applied mathematics, data science, or a related field, with >15 years of relevant industry experience.
• Recognized scientific or technical leadership in CMC development, technology transfer, manufacturing sciences, process development, analytical development, or model-informed development.
• Demonstrated success defining and leading complex, cross-functional technology strategies or portfolios from concept through sustained implementation.
• Strong understanding of CMC development-to-manufacturing handoffs, scale-up, control strategy, process and analytical models, and regulated product development.
• Broad knowledge of mechanistic, statistical, hybrid, empirical, and AI/ML modeling approaches and their fit-for-purpose application across CMC domains.
• Ability to develop integrated strategies that balance common capabilities with the distinct scientific and operational needs of different modalities.
• Ability to communicate complex technical concepts clearly to scientists, engineers, modelers, quality and regulatory partners, and senior executives.
• Track record of influencing across organizational boundaries and resolving ambiguity, competing priorities, and complex dependencies.

Responsibilities

• Lead scientific and technical leadership for the integrated portfolio of models enabling digitally supported CMC technology transfer.
• Define cross-modality framework for model requirements, reuse, and modality-specific solutions.
• Guide development of mechanistic, statistical, hybrid, empirical, and AI/ML models with clear use cases and validation.
• Set expectations for model lifecycle management including prioritization, qualification, deployment, maintenance, reuse, and retirement.
• Translate emerging scientific and regulatory trends into a pragmatic CMC modeling roadmap.
• Own and refine Brick 1 modeling strategy, roadmap, milestones, and value realization across sites.

Skills

Analytical Thinking

Bioanalytical Techniques

Chemistry

CMC Strategy

Data Analysis

Experimentation

Influencing Skills

Manufacturing

Product Development

R&D Strategy

Regulatory CMC

Scientific Leadership

Strategic Foresight

Technology Transfer

Education

PhD in chemical engineering, chemistry, biochemistry, pharmaceutical sciences, systems engineering, applied mathematics, data science, or related field

Job description

Merck seeks a Distinguished Scientist to lead Brick 1 within CMC Lighthouse Pillar 2, Digitally Enabled Technology Transfer. You will define a unified modeling strategy across CMC domains and modalities to enable faster, more predictive technology transfer decisions across development, manufacturing and commercialization.

You will guide mechanistic, statistical, hybrid, empirical, and AI/ML models, manage lifecycle governance, and drive deployment, reuse, and capability building across programs