Dist. Scientist, Research Science

MSD•Boston, MA

1d•$210,400 - $331,100•Hybrid

About The Position

The Distinguished Scientist provides 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 role defines the required landscape of mechanistic, statistical, hybrid, empirical, and AI/ML models; connects models across CMC domains; develops a coordinated, risk-based roadmap for common and modality-specific needs; and translates modeling strategy into prioritized use cases, fit-for-purpose model suites, business process changes, implementation, and measurable improvements in transfer execution. The position provides scientific authority and portfolio leadership, including ownership of the integrated modeling strategy, roadmap, milestones, dependencies, resources, and value case. It establishes model governance and lifecycle expectations, partners with Quality, Regulatory, Manufacturing, IT, and scientific functions on documentation and compliance, and builds alignment and modeling capability across organizational boundaries. It reports progress, risks, decisions, and value realization to scientific and executive governance bodies. The role is based primarily in Rahway, New Jersey, with a hybrid work arrangement.

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.
Required skills include 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 the scientific authority for the integrated portfolio of models required for digitally supported CMC technology transfer.
Establish a cross-modality framework for identifying 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 from model concept and development through 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 model governance proportionate to model risk, intended use, and decision impact.
Partner with Quality, Regulatory, Manufacturing, IT, and scientific functions to define expectations for model documentation, traceability, verification, validation, change control, access, and lifecycle oversight.
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 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.