Director Data AI & Analytics

Merck & Co.

Irvine (CA)

Hybrid

USD 154,565 - 216,100

Full time

14 days+

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Job summary

FUJIFILM Biosciences in Irvine, CA seeks a Director Data, AI and Analytics to own strategy, platforms, and operating model for Data, AI and Analytics across three life-sciences businesses. You will lead a cross-site CoE and partner with QA/CSV, Security, Lab IT, and ERP to deliver business value.

Required: 10+ years in data/analytics leadership in regulated life sciences; strong governance and hands-on experience with data platforms and MLOps. BS/BA required; hybrid US-based role.

Qualifications

  • 10+ years leading Data/Analytics functions in regulated life sciences.
  • 5+ years in regulated life sciences (biotech, pharma, CDMO).
  • Hands-on ownership of enterprise data platforms and analytics programs.
  • Strong GxP/CSV/CSA knowledge with practical application.
  • Experience with bioinformatics analytics/pipelines and LIMS/ELN integration.
  • Proven track record turning Data/AI programs into measurable outcomes.

Responsibilities

  • Define multi-year Data/AI roadmap for California and Wisconsin locations.
  • Stand up Data, AI & Analytics Center of Excellence with domain squads.
  • Run governance: Steering Committee, Model Risk & Compliance Board.
  • Own enterprise data platform (lakehouse/warehouse) and ingestion/orchestration.
  • Implement catalog/lineage, data quality rules, access controls; drive SLAs.
  • Integrate MES/QMS/LIMS/ERP/OSI PI into data platform.
  • Deliver executive and operational analytics (FPY, OEE, batch release).
  • Enable governed self-service with certified datasets and KPI library.
  • Lead Data Science programs for manufacturing quality, supply chain, R&D.
  • Develop bioinformatics pipelines and agentic AI with MLOps.

Skills

Data governance
GxP compliance
Executive communication
Cross-functional leadership
MLOps
AI governance
Project management
English proficiency

Education

BS/BA in a relevant field

Tools

Databricks
Snowflake
BigQuery
Azure
AWS
Spark
Airflow
Power BI
Tableau
Collibra

Job description

Position Overview
Position Description

We are hiring a Director Data, AI and Analytics. The Director Data, AI and Analytics will own the strategy, platforms, operating model, and outcomes for Data, AI, and Analytics across three FUJIFILM life-sciences businesses. In highly regulated GxP environments, deliver a trusted data backbone, governed self-service analytics, advanced analytics, bioinformatics pipelines, and agentic AI-meeting 21 CFR Part 11/EU Annex 11, ALCOA+, and CSV/CSA expectations. Lead a cross-site team (CoE + domain squads), partner with QA/CSV, Security, Lab IT, M&Q Systems, and ERP, and convert data and AI into measurable business value.

This position is hybrid in Irvine, CA.
Company Overview

At FUJIFILM Biosciences, we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world's biggest health challenges.

Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you're ready to make an impact, your future belongs with us at FUJIFILM Biosciences.

Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description
Responsibilities:
  • Define the multi-year Data/AI roadmap for locations in California and Wisconsin; align to business priorities and compliance needs.
  • Stand up a Data, AI & Analytics Center of Excellence with domain-aligned product squads (M&Q, R&D/Bioinformatics, Finance/SC).
  • Run governance: Data & AI Steering Committee, Model Risk & Compliance Board; assign data product ownership.
  • Own the enterprise data platform (lakehouse/warehouse), ingestion (ELT/CDC), orchestration, and semantic/metric layers.
  • Implement catalog/lineage, data quality rules, access controls; drive data product SLAs and ownership.
  • Integrate core systems: MES (e.g., PAS-X), QMS (ETQ/Veeva), LIMS/ELN (LabWare/Benchling), ERP (e.g., SAP/Oracle), OSI PI/AVEVA, and instrument data hubs.
  • Deliver executive and operational analytics (FPY/yield, OEE, deviation/CAPA TAT, batch release, QC throughput, inventory turns, cost-to-serve).
  • Enable governed self-service (certified datasets/semantic models, KPI library, training, community of practice).
  • Lead data science programs for manufacturing quality, supply chain, and R&D.
  • Own bioinformatics analytics and pipelines (e.g., NGS/omics workflows, imaging pipelines, assay analytics) and integration with lab systems and data platforms.
  • Build responsible and agentic AI capabilities (assistants/co-pilots, retrieval/grounding, task automation) with MLOps (experiment tracking, model registry, CI/CD, monitoring, retraining). Separate GxP vs non-GxP AI; ensure intended use, explainability, validation/CSA, and periodic review for regulated models.
  • Embed compliance by design: 21 CFR Part 11, Annex 11, ALCOA+, data retention/archival, audit trails.
  • Partner with QA/CSV on risk-based validation, test evidence, and inspections; maintain validated state for applicable analytics/data flows.
  • Coordinate with Corporate Security on classification, RBAC/least privilege, encryption, logging/monitoring, and incident response for data/AI workloads.
  • Govern AI safety: model cards, red-team testing, bias/fairness checks, PHI/PII safeguards, vendor due diligence.
  • Prioritize a portfolio of use cases with quantified value; pilot, scale winners, retire low-value work.
  • Publish a quarterly "Data & AI Outcomes" report (business impact, adoption, cost/performance, compliance posture).
  • Select and govern platform vendors (cloud, data/ML, BI, bioinformatics tools) and SIs; negotiate commercials, SLAs, exit terms.
  • Drive FinOps: usage visibility, rightsizing, tiered storage, and cost/performance optimization.
  • Hire and develop data/platform/analytics engineers, data scientists/ML engineers, bioinformatics engineers, and product managers.
  • Build cross-site career paths and a culture of reliability, compliance, and measurable impact.
Required Skills/Education:
  • BS/BA (or equivalent) in Business, Computer Science or similar.
  • 10+ years leading Data/Analytics functions with 5+ years in regulated life sciences (biotech, pharma, CDMO); multi-site/global experience.
  • Ownership of enterprise data platforms (lakehouse/warehouse), analytics programs, and MLOps in production.
  • Strong GxP/CSV/CSA knowledge with practical application in analytics/AI and data flows; 21 CFR Part 11/Annex 11/ALCOA+.
  • Hands-on familiarity with bioinformatics analytics/pipelines (e.g., NGS/omics, imaging, workflow orchestration) and integration with LIMS/ELN and lab systems.
  • Proven record converting Data/AI programs into business outcomes (e.g., cycle time, yield/FPY, cost, quality).
  • Cross-functional leadership with QA/CSV, Manufacturing/Quality, R&D, Security, ERP/MES/QMS owners, and vendors.
  • Excellent executive communication and pragmatic technical guidance.
  • Platforms: Databricks/Snowflake/BigQuery; Azure/AWS data services; Spark; DBT; Airflow/Prefect; Kafka/EventHub.
  • BI: Power BI/Tableau; semantic/metrics layers; KPI governance.
  • MLOps/AI: MLflow/W&B, SageMaker/Azure ML; vector DBs/RAG; LLM orchestration; agent frameworks; feature stores.
  • Bioinformatics: Nextflow/Snakemake, CWL/WDL; common tools (e.g., GATK) or imaging/omics pipelines; HPC/containers.
  • Governance: Collibra/Alation/Atlan; model risk management/AI governance.
  • Certifications: GAMP 5/CSA, ITIL, cloud (Azure/AWS), or data governance certifications.
  • Ability to speak, read, and write in English.
  • Good verbal and written communication skills; effective presentation skills.
Salary and Benefits:
  • For California, the base salary range for this position is $154,565.00 - $216,100. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
  • Medical, Dental, Vision
  • Life Insurance
  • 401k
  • Paid Time Off

*#LI-hybrid

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (flbi@fujifilm.com).

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