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 company's 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 company's 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
- Bachelor's 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.