Associate Director/Director, CMC Digital Business Partner

About Us …

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our cytoDRiVE® technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program is currently in clinical development for the treatment of patients with metastatic melanoma and non-small cell lung cancer.

We’re proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our Research team is based in the heart of Cambridge, MA, and Technical Operations team is based in our purpose built facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.

Our Opportunity...

We’re 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 the Tech Ops/CMC business systems owners to translate business needs into inspection-ready digital capabilities aligned to the business’ priorities and milestones (including BLA readiness and commercial launch) and approved budget. Near term priorities include cell orchestration (chain of identity and custody), process data history and analytics, eQMS/document control, and ERP integration.

In partnership with business system owners, you will select, implement, validate, integrate, support, and continuously improve key CMC digital platforms across internal and external operations through direct execution and engagement and oversight of consultants, systems integrators, and managed-service partners where warranted. The successful candidate will be highly collaborative and committed to understanding how the business runs in the internal processing suites, analytical labs, and partner interfaces.

As a member of our Digital Solutions & Technology team, you will be a vital part of a highly collaborative group working to unlock the promise of precision cell therapy for patients, starting with our lead program amsoki-cel (OBX-115), a novel engineered tumor-infiltrating lymphocyte (TIL) cell therapy that uses our proprietary cytoDRiVE® platform. This is a unique opportunity to be a valuable contributor in a well-funded clinical company with field-leading advisors, best-in-class partners, and an experienced team.

This is a hybrid role based in Bedford, MA, with periodic travel to CDMO and/or partner sites as needed.

You Will...

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 T echnical 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, and communicating 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, hyper care , support, and ongoing lifecycle management.

Define and b uild 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 that support 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 the identification, prioritization, and activation of all CMC digital projects on time to meet Obsidian ’s overall program and strategy requirements .

Partner with Quality to improve and align Obsidian’s GXP computer system lifecycle QMS processes and practices with industry best practices for late stage / commercial cell and gene therapies including 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.

You Bring...

Core Qualifications

Bachelor's degree in computer science , Engineering, Information Systems, Life Sciences, or a related field, with 10+ y ears of IT/digital experience in the biotech/pharmaceutical industry, including 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 — with 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 — with concrete examples of building credibility with Manufacturing, MSAT, and Quality leaders from a standing start, participating in planning and decisions early, and influencing senior stakeholders without direct authority.

Experience supporting CDMO/CMO external manufacturing or internal (in-house) manufacturing — including establishing data exchange, batch record and QC data transfer, system connectivity, and oversight of partner-executed operations.

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, and supporting 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.

Comfortable operating as a hands-on individual contributor in a small , maturing company environment: personally writing requirements, configuring or testing, and delivering through vendors, consultants, and integrators rather than a large internal team.

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: APIs/middleware, ISA-95 concepts, master data management, and integration of manufacturing systems with ERP, eQMS , and analytics platforms.

Genuine operational curiosity ; fluent enough in the process and the science to hold a peer-level conversation with scientists and manufacturing leads, and disciplined about understanding a workflow before proposing to digitize it.

Successful e xperience managing vendors, contracts, budgets,