Head of Biotherapeutics Data and Modeling Applications (Director)
Responsibilities
- Lead and grow the Biotherapeutics Data and Modeling function and team of data engineers/modelers (strategy, priorities, measures of success).
- Identify and deploy data and digital platforms/tools with DD&T to support process development and scale-up to manufacturing.
- Drive modeling strategy to build robust, validated predictive models (mechanistic, statistical, and machine learning as appropriate).
- Translate model outputs into operational decisions and control strategies to improve quality, yield, cost, safety, reliability, and performance.
- Partner with process development, operations, quality, and IT to meet validation and data integrity requirements.
- Lead data governance/architecture best practices (capture, lineage, storage, access) to enable reproducible models/analytics.
- Monitor external data/digital trends and incorporate insights into the technology roadmap.
- Manage vendors, partnerships, and external collaborations for data engineering and modeling tools.
- Provide strategic oversight of budgets, schedules, and initiatives while mentoring.
Qualifications (Required/Preferred)
- 10+ years relevant experience in biotherapeutics/bioprocess development/data science/computational modeling; 5+ years in leadership.
- Advanced degree (engineering, computational biology, data science, statistics, or related); PhD preferred.
- Experience deploying enterprise data platforms/digital tools for biologics development.
- Proven track record building/validating predictive process-performance models and translating them into operational controls.
- Strong knowledge of regulatory expectations and quality systems for data/models (data integrity, model validation).
- Hands-on knowledge of data engineering/cloud, data architecture, databases, and tooling for model development/deployment.
- Experience collaborating across process development, quality, and IT.
- Excellent communication skills (including presenting to non-technical audiences).
- Vendor/partnership management and professional network building.
- Six Sigma or Lean desirable.
Benefits
- Up to 80 hours sick time/year; up to 120 hours paid vacation for new hires; may include medical/dental/vision, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, and well-being benefits (U.S. based).