Associate Director/Director, CMC Digital Business Partner

The role

The Associate Director/Director, CMC Digital Business Partner will define, deliver, and maintain digital systems to support GMP operations strategy. This person will partner with Technical Operations leadership to translate business needs into digital capabilities for manufacturing, quality, and supply chain.

What you will do

• Serve as the embedded digital business partner for Tech Ops/CMC
• Develop and deliver the CMC digital strategy, roadmap, and systems portfolio
• Translate CMC business needs into prioritized digital capabilities
• Lead technical delivery of GxP systems through personal execution and partner oversight
• Define and build the CMC data architecture and digital interfaces
• Establish a CMC digital system governance framework
• Partner with Quality to align GxP computer system lifecycle processes
• Partner with Information Security, Digital Infrastructure, and Facilities
• Oversee the CMC digital portfolio including financial management and vendor relationships

Required qualifications

• Bachelor's degree in computer science, Engineering, Information Systems, Life Sciences, or a related field
• 10+ years of IT/digital experience in the biotech/pharmaceutical industry
• Significant time owning manufacturing or laboratory systems end to end
• Demonstrated ownership of GxP manufacturing and laboratory systems in a regulated cell therapy, gene therapy, or complex biologics environment
• Hands-on accountability for at least two of: MES/ eBR, LIMS/ELN, cell orchestration (COI/COC), or process data historian/analytics
• Proven success as an embedded business partner to a manufacturing/technical operations organization
• Experience supporting CDMO/CMO external manufacturing or internal manufacturing
• Deep working knowledge of GxP compliance for computerized systems: 21 CFR Part 11, EU Annex 11, GAMP 5 / CSV and CSA-based validation, data integrity (ALCOA+), change control
• Track record delivering full-lifecycle system implementations
• Experience with systems supporting shipping/ logistics and cold chain
• Strong systems integration and data architecture fluency: APIs/middleware, ISA-95 concepts, master data management
• Successful experience managing vendors, contracts, budgets, and systems integrators

Nice to have

• Autologous cell therapy experience
• Experience standing up CMC digital capability in a late stage / commercial company
• Hands-on experience with specific platforms such as TrakCel, SAP Advanced Therapy Orchestration, Apprentice, Benchling, Veeva Vault QMS/ QualityDocs, MasterControl and Process Data Analytics Tools
• Familiarity with eQMS, controlled document management, and training/LMS platforms, and with facilities/engineering systems
• Cloud, data engineering, or advanced analytics/AI experience applied to process data
• Experience with serialization, labeling, or track-and-trace systems
• Familiarity with OT/IT security frameworks and shop-floor network segmentation
• Formal project/program management or Agile certification (PMP, SAFe) or Lean/Six Sigma training

Benefits

• Annual incentive bonus
• Employee stock options
• Comprehensive medical, dental, and vision coverage
• Company contributions to health savings and retirement accounts
• Ample paid time off
• Access to wellness programs
• Rich career growth opportunities

About the company

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. The company applies cytoDRiVE® technology to control protein expression for enhanced therapeutic efficacy and safety.