Obsidian Therapeutics

• Provide strategic and operational leadership for Drug Product programs supported through external manufacturing and testing partners. • Build systems/processes and organize resources to establish and achieve product release cycle times • Provide QC oversight of CDMOs and contract test laboratories (CTLs) • Direct and oversee method validation and transfer activities, including tech transfer to an external CDMO, to ensure GMP compliance • Assist with PPQ readiness and BLA preparatory activities • Lead QC investigation of quality events including laboratory investigations, OOS/OOT and deviations, and support manufacturing investigations at CDMOs and CTLs • Support development of specifications for raw material, drug substance, intermediate and final product testing, and stability testing • Author and review test methods, protocols, reports, and associated documents • Support data trending and quality metrics • Support regulatory submission activities • Collaborate closely with QA, Regulatory, Supply Chain, MSAT, AD, and PD groups and external key partners • Monitor and evaluate external laboratory performance using KPIs, driving improvements in efficiency and right-first-time execution • Assist with continuous improvement of quality and compliance • Regularly perform QC Person In Plant activities at Obsidian’s CDMO facilities, and other duties as needed.

• Develop and execute Digital Solutions & Technology operations strategy aligned with Obsidian’s growth, compliance needs, and culture. • Lead day-to-day operations, including infrastructure, cloud environments, enterprise systems, and lab/scientific software. • Manage MSP resources, ensuring high-quality support and service levels. • Partner with Info Security lead to ensure robust cybersecurity and data protection. • Optimize Digital Solutions & Technology processes (incident, problem, change management) and drive adoption of best practices, with a strong emphasis on ITIL and change management in a controlled, regulated environment. • Manage vendor relationships and operations budget. • Support onboarding/offboarding, access management, and end-user training. • Foster a culture of accountability, collaboration, and continuous improvement. • Identify, assess, and mitigate IT risks; develop and maintain business continuity and disaster recovery plans. • Work closely with Facilities, Lab Operations, and other business units to ensure Digital Solutions meet evolving scientific and operational needs. • Drive process optimization and adoption of new technologies to improve service delivery and operational efficiency. • Define, track, and report on IT operational KPIs (e.g., uptime, ticket resolution, user satisfaction, compliance metrics). • Prepare for and support regulatory audits (FDA, SOX, etc.), ensuring documentation and processes are audit-ready.