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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in CMC development and technology transfer, with a strong focus on model-informed strategies and cross-functional leadership. Proven ability to communicate complex technical concepts and influence stakeholders across organizational boundaries.
Highest-signal resume keywords
Ph.D. In Chemical EngineeringCMC StrategyAI/ML Modeling ApproachesScientific LeadershipTechnology Transfer
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Bioanalytical TechniquesData AnalysisExperimentationManufacturingProduct DevelopmentRegulatory CMCAnalytical DevelopmentProcess DevelopmentModel DevelopmentStatistical Modeling
Soft Skills
Analytical ThinkingInfluencing SkillsStrategic Foresight
Industry Keywords
CMC DevelopmentTechnology TransferManufacturing SciencesCross-Functional LeadershipModel-Informed DevelopmentRegulated Product DevelopmentScale-UpControl StrategyComplex DependenciesStakeholder Engagement
About the role
Key responsibilities & impact- Provide scientific, technical, and strategic leadership for Brick 1 within CMC Lighthouse Pillar 2, Digitally Enabled Technology Transfer
- Define and lead an integrated strategy and execution plan for establishing, maturing, connecting, and deploying models across CMC domains and modalities
- Lead product, process, analytical, manufacturing, and technology-transfer modeling capabilities
- Identify mechanistic, statistical, hybrid, empirical, and AI/ML models needed across CMC domains
- Establish a coherent strategy connecting product, process, analytical, formulation, materials, equipment, scale-up, control strategy, and manufacturing models
- Develop a coordinated, risk-based roadmap for common and modality-specific CMC needs
- Convert modeling strategy into prioritized use cases, model suites, business process changes, implementation, and measurable improvements in transfer execution
- Serve as scientific authority for the integrated portfolio of models supporting digitally enabled CMC technology transfer
- Guide model development and application, including intended use, assumptions, uncertainty, applicability, verification, and validation
- Set expectations for model lifecycle management, including prioritization, development, qualification, deployment, maintenance, reuse, and retirement
- Own and refine the Brick 1 integrated modeling strategy, roadmap, milestones, dependencies, resource needs, and value case
- Create inventories and gap assessments of existing and required models
- Prioritize modeling investments and lead cross-functional teams through qualification, implementation, adoption, sustainment, and reuse
- Establish decision rights, governance, technical review mechanisms, and escalation paths
- Manage interdependencies with other Lighthouse bricks and enterprise initiatives
- Communicate progress, risks, decisions, and value realization to scientific and executive governance bodies
- Establish fit-for-purpose model governance and partner with Quality, Regulatory, Manufacturing, IT, and scientific functions on documentation, traceability, verification, validation, change control, access, and lifecycle oversight
- Define model-readiness criteria for technology transfer and ensure appropriate governance, including GxP applicability where required
- Build alignment across 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
- Develop playbooks, model-development standards, reuse patterns, and communities of practice
- Mentor scientists, engineers, modelers, and technical leaders
- Represent the organization in external consortia, collaborations, and scientific forums related to advanced CMC modeling
Requirements
What you’ll need- 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; 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 balancing common capabilities with distinct scientific and operational needs of different modalities
- Ability to communicate complex technical concepts 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
- Technology Transfer
- US and Puerto Rico residency
Benefits
Comp & perks- Annual bonus
- Long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Hybrid work arrangement