CMC Modeling Leader — Digital Tech Transfer

Merck & Co.; Cambridge (MA); Hybrid; USD 210,000 - 331,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Merck & Co. seeks a Distinguished Scientist to lead Brick 1 within CMC Lighthouse Pillar 2 for digitally enabled technology transfer.

You will define strategies to mature, connect, and deploy models across domains and modalities, guiding product, process, analytical, formulation, materials, equipment, and scale-up models. You will drive deployment, governance, and capabilities to accelerate transfer decisions, with cross-functional leadership and a strong emphasis on regulatory and scientific

Qualifications

• Ph.D. and >15 years of industry experience or equivalent mix of education and experience.
• Demonstrated leadership in cross-functional technology strategies or portfolios.
• Strong understanding of model-informed development and CMC handoffs.

Responsibilities

• Serve as scientific authority for integrated portfolio of models for digitally supported CMC technology transfer.
• Define an across-modality framework for model requirements and reuse.
• Guide development of mechanistic, statistical, hybrid, empirical, and AI/ML models with clear usage and validation.
• Set expectations for model lifecycle management including deployment and retirement.
• Lead cross-functional teams from concept through qualification and adoption.

Skills

Analytical Thinking

Bioanalytical Techniques

Biochemistry

Chemistry

CMC Strategy

Data Analysis

Experimentation

Influencing Skills

Manufacturing

Product Development

R&D Strategy

Regulatory CMC

Scientific Leadership

Strategic Foresight

Technology Transfer

Education

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

Job description

Merck & Co. seeks a Distinguished Scientist to lead Brick 1 within CMC Lighthouse Pillar 2 for digitally enabled technology transfer.

You will define strategies to mature, connect, and deploy models across domains and modalities, guiding product, process, analytical, formulation, materials, equipment, and scale-up models. You will drive deployment, governance, and capabilities to accelerate transfer decisions, with cross-functional leadership and a strong emphasis on regulatory and scientific