Associate Director/Director, CMC Digital Business Partner

Obsidian Therapeutics•Bedford, MA

22d•$175,500 - $251,500•Hybrid

About The Position

Obsidian Therapeutics 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 that support its GMP operations strategy. The role partners with Tech Ops/CMC business systems owners to translate business needs into inspection-ready digital capabilities aligned with business priorities, milestones—including BLA readiness and commercial launch—and approved budgets. Near-term priorities include cell orchestration and chain of identity and custody, process data history and analytics, eQMS/document control, and ERP integration. The role selects, implements, validates, integrates, supports, and continuously improves key CMC digital platforms across internal and external operations. Delivery may be performed directly or through consultants, systems integrators, and managed-service partners. Success requires understanding how the business operates in internal processing suites, analytical labs, and partner interfaces. As part of the Digital Solutions & Technology team, this position supports Obsidian’s cell therapy programs, including lead program amsoki-cel (OBX-115), an engineered tumor-infiltrating lymphocyte cell therapy using the cytoDRiVE platform. The role is hybrid and based in Bedford, Massachusetts, with periodic travel to CDMO and/or partner sites as needed.

Requirements

Bachelor’s degree in computer science, engineering, information systems, life sciences, or a related field.
10+ years of IT/digital experience in the biotechnology or pharmaceutical industry, including significant experience 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, with hands-on accountability for at least two of MES/eBR, LIMS/ELN, cell orchestration (COI/COC), or process data historian/analytics.
Proven experience as an embedded business partner to a manufacturing/technical operations organization, including building credibility with Manufacturing, MSAT, and Quality leaders and influencing senior stakeholders without direct authority.
Experience supporting CDMO/CMO external or internal manufacturing, including data exchange, batch record and QC data transfer, system connectivity, and oversight of partner-executed operations.
Deep working knowledge of GxP computerized systems compliance, including 21 CFR Part 11, EU Annex 11, GAMP 5, CSV and CSA-based validation, ALCOA+ data integrity, change control, and regulatory inspections or partner audits.
Track record delivering full-lifecycle system implementations from business case and vendor selection through validation, go-live, and sustained support, on schedule and on budget.
Comfort operating as a hands-on individual contributor in a small, maturing company, personally writing requirements, configuring or testing, and delivering through vendors, consultants, and integrators.
Experience with systems supporting shipping/logistics and cold chain for temperature-sensitive or cryopreserved material, including courier/3PL integration and chain-of-custody traceability.
Strong systems integration and data architecture fluency, including APIs/middleware, ISA-95 concepts, master data management, and integration of manufacturing systems with ERP, eQMS, and analytics platforms.
Operational curiosity and sufficient familiarity with processes and science to engage with scientists and manufacturing leads, and a disciplined approach to understanding workflows before proposing digitization.
Experience managing vendors, contracts, budgets, systems integrators, or managed-service partners.
Excellent written, verbal, and visual communication skills, with the ability to translate between technical and operational/scientific audiences and adapt communication to the audience.
Ability to cultivate collaboration, transparency, and accountability across teams and build trust and credibility internally and externally.
Ability to build buy-in and alignment across teams, senior leadership, and external partners with urgency and integrity.
Tenacity and resilience when navigating significant scientific and business challenges.
Strong organizational skills and ability to manage multiple tasks of varying complexity in parallel.
Ability to remain calm under pressure and lead others through complex situations.
Ability to seek needed information and support to make informed decisions and meet objectives.
Ability to build followership through transparency, persuasion, enthusiasm, and willingness to work hard with others.
Commitment to continuous learning, following innovations, fostering innovative thinking, and adopting fit-for-purpose approaches.
Reflective, self-aware leadership and a growth mindset.

Nice To Haves

Autologous cell therapy experience, including vein-to-vein scheduling, apheresis and infusion site coordination, and patient/COI-linked manufacturing.
Experience establishing CMC digital capabilities in a late-stage or commercial company, including first-time greenfield deployments.
Hands-on experience with platforms such as TrakCel, SAP Advanced Therapy Orchestration, Apprentice, Benchling, Veeva Vault QMS/QualityDocs, MasterControl, or process data analytics tools such as Skyland PIMS.
Familiarity with eQMS, controlled document management, and training/LMS platforms, and with facilities/engineering systems such as BMS, environmental monitoring, CMMS, and calibration.
Hands-on cloud, data engineering, or advanced analytics/AI experience applied to process data, such as multivariate analysis, CPV, predictive monitoring, or digital twin concepts.
Experience with serialization, labeling, or track-and-trace systems, and with clinical supply/IRT interfaces to manufacturing.
Familiarity with OT/IT security frameworks and shop-floor network segmentation.
Formal project/program management or Agile certification, such as PMP or SAFe, or Lean/Six Sigma training.

Responsibilities

Serve as the embedded digital business partner for Tech Ops/CMC and build trusted relationships with Manufacturing, MSAT/Process Development, Analytical Development, Quality, Supply Chain, CMC Regulatory, Facilities, CMC Program Management, and external partners.
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.
Translate CMC business needs into prioritized digital capabilities, balancing business value, compliance, funding, timing, and technical complexity, and communicate options and tradeoffs to Tech Ops and Digital leadership.
Lead technical delivery of GxP systems, including business cases, requirements, vendor selection, solution architecture, configuration, integration, data migration, validation, deployment, hyper care, support, and lifecycle management.
Define and build CMC data architecture and digital interfaces across manufacturing, quality, laboratory, logistics, facilities/engineering, CDMO, and ERP data, using governed master data, integrations, contextualized data models, and self-service analytics.
Support process monitoring, CPV, investigations, product disposition/release, and APR while maintaining compliance, data privacy, and security.
Partner with CMC project management to establish a governance framework for identifying, prioritizing, and activating CMC digital projects on time and in support of company program and strategy requirements.
Partner with Quality to improve and align GxP computer system lifecycle QMS processes with industry practices for late-stage and commercial cell and gene therapies.
Establish and maintain fit-for-purpose CSV/CSA and data integrity practices, including GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+, audit trail review, periodic review, change control, and inspection/audit support for CMC digital systems.
Partner with Information Security, Digital Infrastructure, and Facilities to deliver secure, scalable CMC capabilities.
Oversee the CMC digital portfolio, including financial management, vendor relationships, contracts, and service delivery through a lean operating model.