Director of Data Management & Analytics

Overview

The Advanced Regenerative Manufacturing Institute (ARMl)IBioFabUSA is a Member-based non-profit member-driven public-private partnership with a mission to advance the bioeconomy and transform the future of human health. ARMI provides technical and wrap-around commercialization services to companies seeking to advance technologies that will contribute to this impact.

The Impact That You Will Make

The Director will serve as a strategic and technical leader responsible for defining and executing the companys technical data strategy. The Director will bridge the gap between scientific research and scaled automated manufacturing by overseeing the data infrastructure (ingestion governance architecture) and advanced analytical execution (predictive modeling statistical analysis and machine learning) needed to support scientific discovery autologous/allogeneic cell therapy production real-time chain-of-custody/chain-of-identity tracking and regulatory submissions. This role is uniquely critical in cell therapy where success depends on integrating complex high-dimensional data across R&D preclinical development manufacturing (CMC) supply chain/logistics and commercial operations. The ideal candidate combines deep data strategy and technology leadership with an understanding of the unique data challenges associated with cell therapies including integration of multi-omic and other characterization data biomanufacturing data product tracking and has a working knowledge with stringent regulatory/compliance requirements (FDA EMA GMP GCP GxP).

Your Role

Strategy & Leadership

• Define and drive the technical data strategy and roadmap aligning data and analytics investments with R&D manufacturing and commercial priorities
• Advise the Executive Team on data-driven opportunities and risks
• Build mentor and lead a high-performing team of data engineers data scientists bioinformaticians and data governance/quality specialists
• Establish the companys data culture championing data literacy and evidence-based decision-making across all functions

Data Infrastructure & Architecture

• Oversee design and implementation of a unified data platform/data lake integrating data from R&D preclinical development manufacturing (MES LIMS) supply chain (chain-of-identity/chain-of-custody systems) and commercial operations
• Partner with IT/Digital leadership on cloud infrastructure data pipelines interoperability standards (e.g. HL7 FHIR CDISC) and system integrations (ERP MES LIMS and as needed QMS)

Data Governance Quality & Compliance

• Establish enterprise data governance policies standards and stewardship models to ensure data integrity quality security and phase-appropriate regulatory compliance
• Lead data privacy and security initiatives in partnership with IT Security and Legal

Analytics & Advanced Technology

• Champion the application of advanced analytics machine learning and AI to accelerate scientific discovery optimize manufacturing yield/process parameters and predict supply chain risk
• Enable predictive and prescriptive analytics for manufacturing process optimization and capacity planning
• Evaluate and implement emerging technologies (AI/ML platforms digital twins real-world data/evidence tools) to maintain competitive advantage

Cross-Functional Partnership

• Collaborate closely with R&D Manufacturing/CMC Quality Regulatory Affairs Supply Chain and Commercial teams to understand data needs and deliver fit-for-purpose solutions
• Partner with the Executive Team (if applicable) on technology infrastructure decisions and IT roadmap alignment
• Manage relationships with external vendors data platform providers and technology partners

Your Skills and Experience

• Bachelors degree in Data Science Biostatistics Bioinformatics Life Sciences Computer Science or related field; advanced degree (MS PhD) strongly preferred
• 5-8 years of progressive experience in data architecture data engineering advanced analytics with at least 4 years in life sciences biotech pharma or cell/gene therapy industry ecosystems.
• 3-5 years of direct management experience leading cross-functional data teams.
• Demonstrated experience building enterprise data governance architecture and analytics capabilities from the ground up
• Advanced command of statistical tools and programming (Python R SQL SAS)
• Deep experience with modern cloud data systems (Azure Snowflake AWS)
• Familiarity with R&D and manufacturing/biomanufacturing data systems (ELN MES LIMS ERP)
• Track record of leading and scaling high-performing data and analytics teams
• High level communication and presentation skills with experience presenting to senior leadership

Additional Experience We Value

• Direct cell therapy or advanced therapy medicinal product (ATMP) experience strongly preferred
• Experience with autologous or allogeneic cell therapy manufacturing and chain-of-identity/chain-of-custody data systems
• Familiarity with mass spectrometry-based multi-omics single-cell genomics flow cytometry and other cell characterization data types
• Experience implementing AI/ML solutions in a regulated life sciences environment
• Experience in a high-growth fast-paced biotech environment (clinical-to-commercial transition)

By applying I understand that any offer of employment is contingent upon the successful completion of a background check in accordance with applicable laws.

Required Experience:

Director