Director, CMC Digital Solutions

Obsidian Therapeutics, Inc.; Bedford (MA); Hybrid; USD 176,000 - 252,000; Full time

Benefits offered by this job

Stock options

Annual bonus

Competitive benefits package

Paid time off

Job summary

Obsidian Therapeutics, Inc. is seeking a highly experienced Associate Director/Director, CMC Digital Business Partner, to partner with Tech Ops/CMC leadership.

You will define and deliver digital systems to support GMP operations, including cell orchestration, data history/analytics, eQMS, and ERP integration. You will oversee vendor relationships and drive digital portfolio across manufacturing, quality, and analytics.

Qualifications

• Bachelor's degree in computer science, engineering, information systems, life sciences, or related field.
• 10+ years IT/digital experience in biotech/pharma industry, including owning manufacturing or laboratory systems end to end.
• Experience owning GxP manufacturing/lab systems in regulated cell therapy or similar environment.
• Experience with CDMO/CMO external manufacturing data exchange and system connectivity.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity (ALCOA+), change control.

Responsibilities

• Serve as embedded digital business partner for Tech Ops/CMC; build trusted relationships with manufacturing and QA.
• Develop and deliver the CMC digital strategy, roadmap, and systems portfolio; align with BLA readiness and launch.
• Translate business needs into prioritized digital capabilities with clear tradeoffs.
• Lead technical delivery of GxP systems; manage vendors, requirements, and validation.

Skills

IT/digital experience

GxP/compliance

Vendor management

Systems integration

Cross-functional partner

Education

Bachelor's degree in CS/Engineering/IS/Life Sciences

Tools

TrakCel

SAP Advanced Therapy Orchestration

Apprentice

Benchling

Veeva Vault QMS/QualityDocs

MasterControl

Job description

Obsidian Therapeutics, Inc. is seeking a highly experienced Associate Director/Director, CMC Digital Business Partner, to partner with Tech Ops/CMC leadership.

You will define and deliver digital systems to support GMP operations, including cell orchestration, data history/analytics, eQMS, and ERP integration. You will oversee vendor relationships and drive digital portfolio across manufacturing, quality, and analytics.