Associate Director/Director - CMC Digital Business Partner

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 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, 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 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 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+ years 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 experience managing vendors, contracts, budgets, and systems integrators or managed-service partners.
• Excellent written and verbal communication skills, with the ability to translate between technical and operational/scientific audiences.
• Cultivates collaboration, transparency, and accountability within and across teams; recognizes success requires interdisciplinary thinking and partnership. 
• Inspires confidence, credibility, and trust internally and externally; recognized for high integrity. 
• Operates with Urgency, adept at building buy-in and driving alignment within and across teams, senior leadership, and external partners.  
• Exceptional communication skills in verbal, written, and visual formats, and adapted to the audience.  
• Tenacious and resilient – has navigated significant challenges (scientific and business) and is not easily daunted.  
• Excellent organizational skills; able to manage multiple tasks of varying degrees of complexity in parallel.  
• Remains calm under pressure and leads others through complex situations.  
• Seeks the data, information, and support needed (internally and externally) to make efficient and informed decisions and meet objectives.   
• Builds followership by being transparent, persuasive, excited about the work, and willing to work hard together to get the job done.  
• Continuous learner – actively follows innovations in area of expertise, fosters innovative thinking, and adopts novel approaches that are fit for purpose. 
• Reflective and self-aware; leads by example with a growth mindset.

Bonus Qualifications

• Autologous cell therapy experience, including vein-to-vein scheduling, apheresis and infusion site coordination, and patient/COI-linked manufacturing.
• Experience standing up CMC digital capability in a late stage / commercial company including first-time (greenfield) deployments.
• Hands-on experience with specific platforms such as TrakCel/, SAP Advanced Therapy Orchestration, Apprentice, Benchling, Veeva Vault QMS/QualityDocs, MasterControl and Process Data Analytics Tools such as Skyland PIMS
• Familiarity with eQMS, controlled document management, and training/LMS platforms, and with facilities/engineering systems (BMS, environmental monitoring, CMMS, calibration).
• Cloud, data engineering, or advanced analytics/AI experience applied to process data (e.g., multivariate analysis, CPV, predictive monitoring, digital twin concepts). – NMB: Hands on, ie. Separate it from via vendor
• 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 (PMP, SAFe) or Lean/Six Sigma training.

Anticipated Base Salary Range 175500 - 251500 USD