Associate Director/Director, CMC Digital Business Partner
Obsidiantherapeutics · Bedford, MA (HYBRID)
About this role
**About Obsidian Therapeutics** Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply its **cytoDRiVE®** technology in cell and gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. The lead program is in clinical development for metastatic melanoma and non-small cell lung cancer. **Our Opportunity** Obsidian is seeking an **Associate Director/Director, CMC Digital Business Partner** to work closely with Technical Operations leadership to define, deliver, and maintain the digital systems needed to support and enable Obsidian’s GMP operations strategy. In this role, you will partner with Tech Ops/CMC business systems owners to translate business needs into inspection-ready digital capabilities aligned to business priorities and milestones (including **BLA readiness** and **commercial launch**) and the approved budget. Near-term priorities include **cell orchestration (chain of identity and custody)**, **process data history and analytics**, **eQMS/document control**, and **ERP integration**. **Hybrid Role** This is a **hybrid** role based in **Bedford, MA**, with periodic travel to **CDMO and/or partner sites** as needed. --- **Core Responsibilities** - Serve as the embedded digital business partner for **Tech Ops/CMC**, building trusted relationships with Manufacturing, MSAT/Process Development, Analytical Development, Quality, Supply Chain, CMC Regulatory, Facilities, CMC Program Management, and external partners as needed. - Partner with Tech Ops/CMC leadership to develop and deliver the **CMC digital strategy, roadmap, and systems portfolio**, serving as Technical System Owner for platforms supporting manufacturing execution, cell orchestration/COI-COC, laboratory informatics, logistics/distribution, quality operations, and ERP integration—aligned with **BLA and commercial launch readiness**. - Translate CMC business needs into aligned, prioritized, and delivered digital capabilities—balancing business value, compliance, funding, timing, and technical complexity; communicate options and tradeoffs clearly to both Tech Ops and Digital leadership. - Lead technical delivery of **GxP systems** personally and through partners, including business case, requirements, vendor selection, solution architecture, configuration, integration, data migration, validation, deployment, hypercare, support, and ongoing lifecycle management. - Define and build the CMC data architecture and digital interfaces across manufacturing, quality, laboratory, logistics, facilities/engineering, CDMO, and ERP data through governed master data, high-value digital integrations, contextualized data models, and self-service analytics supporting process monitoring, CPV, investigations, product disposition/release, and APR—while maintaining high levels of compliance, data privacy, and security. - Partner with CMC project management to define and establish a CMC digital system governance framework for identifying, prioritizing, and activating all CMC digital projects on time to meet Obsidian’s overall program and strategy requirements. *(Additional responsibilities were present in the source text but were truncated.)*
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