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Salary: USD 175,500 - 251,500 / annual
Obsidian Therapeutics is seeking an Associate Director/Director, CMC Digital Business Partner to serve as the embedded digital systems leader for Technical Operations and Chemistry, Manufacturing & Controls (CMC). You will work closely with Tech Ops leadership to define, deliver, and maintain digital systems supporting Obsidian's GMP operations strategy, with near-term priorities including cell orchestration (chain of identity and custody), process data history and analytics, eQMS/document control, and ERP integration.
In this hybrid role based in Bedford, MA (with periodic travel to CDMO and partner sites), you will partner with business system owners to translate CMC business needs into inspection-ready digital capabilities aligned to BLA readiness and commercial launch milestones. You will serve as Technical System Owner for platforms supporting manufacturing execution, cell orchestration/chain of custody, laboratory informatics, logistics/distribution, quality operations, and ERP integration.
Key responsibilities include:
- Serving as the embedded digital business partner for Tech Ops/CMC, building trusted relationships across Manufacturing, Process Development, Analytical Development, Quality, Supply Chain, Regulatory, Facilities, Program Management, and external partners.
- Developing and delivering the CMC digital strategy, roadmap, and systems portfolio aligned with BLA and commercial launch readiness.
- Translating CMC business needs into prioritized digital capabilities, balancing business value, compliance, funding, timing, and technical complexity.
- Leading technical delivery of GxP systems personally and through partners, including business case development, requirements definition, vendor selection, solution architecture, configuration, integration, data migration, validation, deployment, and ongoing lifecycle management.
- Defining and building the CMC data architecture and digital interfaces across manufacturing, quality, laboratory, logistics, facilities, CDMO, and ERP systems through governed master data, high-value integrations, contextualized data models, and self-service analytics supporting process monitoring, CPV, investigations, product disposition/release, and annual product reviews while maintaining compliance, data privacy, and security.
- Establishing a CMC digital system governance framework for identification, prioritization, and activation of all CMC digital projects to meet program and strategy requirements.
- Managing vendor relationships, system integrators, and managed-service partners as warranted.
Obsidian Therapeutics is pioneering engineered cell and gene therapies using its proprietary cytoDRiVE® technology. The lead program, amsoki-cel (OBX-115), is a novel engineered tumor-infiltrating lymphocyte (TIL) cell therapy currently in clinical development for metastatic melanoma and non-small cell lung cancer.
REQUIREMENTS:
- 12+ years of experience in pharmaceutical/biotech operations, manufacturing systems, or digital transformation, with at least 5 years in a leadership or technical system owner role.
- Deep knowledge of GMP/GxP regulations, FDA inspection readiness, and CMC compliance frameworks (21 CFR Part 11, ICH Q7, etc.).
- Hands-on experience with manufacturing execution systems (MES), laboratory information management systems (LIMS), electronic quality management systems (eQMS), and ERP platforms in regulated environments.
- Demonstrated success leading end-to-end implementation of complex, mission-critical digital systems in pharma/biotech, including vendor selection, requirements management, validation, and deployment.
- Strong understanding of cell therapy or advanced biologics manufacturing processes, supply chain, and quality operations.
- Experience with data architecture, master data management, and analytics platforms applied to manufacturing/quality data.
- Cloud, data engineering, or advanced analytics/AI experience applied to process data (e.g., multivariate analysis, CPV, predictive monitoring, digital twin concepts)—hands-on experience preferred.
- Experience with serialization, labeling, track-and-trace systems, and clinical supply/IRT interfaces to manufacturing.
- 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 preferred.
- Excellent communication and stakeholder management skills; ability to translate between technical and business audiences.
- Proven ability to work collaboratively in matrix environments and drive alignment across multiple functions.
