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Obsidian TherapeuticsPosted 10/19/2026full-timeBedford • Massachusetts • United StatesSenior💰 $175,500 - $251,500 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing and delivering digital strategies and systems portfolios within the biotech and pharmaceutical industries, with a strong focus on GxP compliance and data architecture. Proven ability to manage vendor relationships, oversee system implementations, and ensure regulatory adherence in manufacturing and laboratory environments.
Highest-signal resume keywords
GxP Manufacturing Systems OwnershipDigital Strategy DevelopmentData Architecture FluencyVendor ManagementRegulatory Compliance Expertise
Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Serve as the embedded digital business partner for Tech Ops/CMC and external partners
- Develop and deliver the CMC digital strategy, roadmap, and systems portfolio
- Serve as Technical System Owner for manufacturing execution, cell orchestration, laboratory informatics, logistics/distribution, quality operations, and ERP integration platforms
- Translate CMC business needs into prioritized digital capabilities
- Lead technical delivery of GxP systems, including business cases, requirements, vendor selection, architecture, configuration, integration, migration, validation, deployment, support, and lifecycle management
- Define CMC data architecture and digital interfaces across manufacturing, quality, laboratories, logistics, facilities, CDMOs, and ERP data
- Establish CMC digital system governance for prioritization and activation of projects
- Improve computer system lifecycle QMS processes, CSV/CSA, data integrity, change control, and inspection/audit support
- Partner with Information Security, Digital Infrastructure, and Facilities to deliver secure, scalable capabilities
- Oversee the CMC digital portfolio, financial management, vendor relationships, contracts, and service delivery
- Support BLA readiness and commercial launch milestones
Requirements
What you’ll need- Bachelor's degree in computer science, Engineering, Information Systems, Life Sciences, or a related field
- 10+ years of IT/digital experience in the biotech/pharmaceutical industry
- 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
- Hands-on accountability for at least two of MES/eBR, LIMS/ELN, cell orchestration (COI/COC), or process data historian/analytics
- Experience as an embedded business partner to a manufacturing/technical operations organization
- Experience supporting CDMO/CMO external manufacturing or internal manufacturing
- Deep working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, CSV/CSA validation, ALCOA+, change control, and regulatory inspections or partner audits
- Track record delivering full-lifecycle system implementations
- Ability to operate as a hands-on individual contributor in a small, maturing company environment
- Experience with shipping/logistics and cold chain for temperature-sensitive or cryopreserved material
- Strong systems integration and data architecture fluency, including APIs/middleware, ISA-95, master data management, ERP, eQMS, and analytics platforms
- Experience managing vendors, contracts, budgets, systems integrators, or managed-service partners
- Excellent written and verbal communication skills
- Bonus qualifications include autologous cell therapy, greenfield deployments, specified CMC platforms, cloud/data engineering/advanced analytics, serialization/track-and-trace, OT/IT security, and PMP/SAFe or Lean/Six Sigma training
Benefits
Comp & perks- Annual incentive bonus as a percentage of actual base salary
- Long-term incentives in the form of employee stock options
- Comprehensive medical, dental, and vision coverage
- Company contributions to health savings and retirement accounts
- Ample paid time off
- Access to wellness programs
- Rich career growth opportunities
- Competitive salary and benefits
- Potential for ownership through stock options
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Manufacturing Execution Systems (MES)Laboratory Information Management Systems (LIMS)Cell OrchestrationData IntegritySystem IntegrationChange ControlCSV/CSA ValidationAPIs/MiddlewareAnalytics PlatformsFull-Lifecycle System Implementations
Soft Skills
Excellent Written CommunicationExcellent Verbal Communication
Tools & Technologies
ERP SystemsEQMSMaster Data ManagementISA-95Cold Chain Logistics
Certifications & Qualifications
PMPSAFeLean/Six Sigma
Industry Keywords
BiotechPharmaceuticalCell TherapyGene TherapyRegulatory Inspections21 CFR Part 11EU Annex 11GAMP 5ALCOA+CDMO/CMO