Dist. Scientist, Research Science

MSD•Rahway, NJ

7h•Hybrid

About The Position

The Distinguished Scientist will provide scientific, technical, and strategic leadership for Brick 1 within CMC Lighthouse Pillar 2, Digitally Enabled Technology Transfer. The role defines and leads an integrated strategy and execution plan for establishing, maturing, connecting, and deploying models across CMC domains and modalities. It leads product, process, analytical, manufacturing, and technology-transfer modeling capabilities to improve process and analytical understanding and make transfer decisions faster, more predictive, and more consistent across development, manufacturing, and commercialization. The position owns the integrated modeling strategy and cross-modality roadmap, including inventorying model needs, prioritizing investments, leading cross-functional delivery, and connecting model outputs to technology-transfer workflows and decisions. It establishes fit-for-purpose governance and model-readiness standards, partnering with Quality, Regulatory, Manufacturing, IT, and scientific functions on documentation, traceability, verification, validation, change control, access, and lifecycle oversight, including GxP applicability where required. The Distinguished Scientist builds alignment across functions and organizational boundaries, influences senior leaders and technical communities, develops standards and communities of practice, mentors scientists and technical leaders, and represents the organization in selected external forums. Success includes broader qualified-model use and reuse, earlier transfer-risk mitigation, improved transfer execution, reduced decision cycle time and manual effort, adoption across development teams and sites, and measurable value tied to cycle time, right-first-time execution, deviations, technical risk, and speed to supply.

Requirements

Ph.D. in chemical engineering, chemistry, biochemistry, pharmaceutical sciences, systems engineering, applied mathematics, data science, or a related field, with more than 15 years of relevant industry experience; or an equivalent combination of education and 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.
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, and technology transfer.

Responsibilities

Serve as scientific authority for the integrated portfolio of models required for digitally supported CMC technology transfer.
Establish a cross-modality framework for selecting required models, reusable common approaches, and modality-specific solutions.
Guide development and application of mechanistic, statistical, hybrid, empirical, and AI/ML models, defining intended use, assumptions, uncertainty, applicability, verification, and validation.
Set expectations for model lifecycle management, including prioritization, development, qualification, deployment, maintenance, reuse, and retirement.
Anticipate scientific, regulatory, and technology trends and translate them into a pragmatic CMC modeling roadmap.
Own and refine the Brick 1 integrated modeling strategy, cross-modality roadmap, milestones, dependencies, resource needs, and value case.
Create an inventory and gap assessment of existing and required models across CMC domains and modalities.
Prioritize modeling investments based on technology-transfer risk, portfolio leverage, scientific value, maturity, and deployment readiness.
Lead cross-functional teams through model concept, development, qualification, implementation, adoption, sustainment, and reuse.
Establish decision rights, governance, technical review mechanisms, and escalation paths for the CMC modeling portfolio.
Manage interdependencies with other Lighthouse bricks and enterprise initiatives to connect model outputs to technology-transfer workflows and decisions.
Communicate progress, risks, decisions, and value realization to scientific and executive governance bodies.
Establish fit-for-purpose governance proportionate to model risk, intended use, and decision impact.
Partner with Quality, Regulatory, Manufacturing, IT, and scientific functions to define model documentation, traceability, verification, validation, change control, access, and lifecycle oversight expectations.
Define model-readiness criteria for technology transfer, including required inputs, boundary conditions, uncertainty, applicability domain, performance expectations, and ownership.
Ensure models and model-enabled workflows are governed appropriately for their intended use, including GxP applicability where required.
Build alignment among process, analytical, formulation, product, manufacturing, quality, regulatory, supply, and digital modeling stakeholders.
Influence senior leaders and technical communities to adopt a shared CMC modeling strategy and coordinated investment plan.
Develop playbooks, model-development standards, reuse patterns, and communities of practice to accelerate adoption and reduce reinvention.
Mentor scientists, engineers, modelers, and technical leaders and strengthen organizational capability in model-informed development and technology transfer.
Represent the organization in selected external consortia, collaborations, and scientific forums related to advanced CMC modeling.