Obsidian Therapeutics

Director

• Serve as the lead MSAT interface to CDMOs, providing technical oversight of clinical manufacturing
• Manage escalations through joint governance forums and collaborate with Process Development
• Define and maintain CPPs, CQAs with CDMOs
• Partner with Process Development and Analytical Development to define process characterization plans
• Define and implement a comprehensive control strategy ahead of PPQ
• Own and maintain the integrity of process monitoring databases
• Lead manufacturing campaign review processes
• Own PPQ strategy and execution
• Oversee authoring and review of batch records, validation protocols, and reports
• Drive governance of tech transfer plans, protocols, and reports
• Structure the MSAT team’s technical materials for BLA readiness
• Author and/or review relevant CMC sections of regulatory submissions
• Serve as MSAT subject matter expert in support of FDA interactions

Director, Manufacturing Science and Technology – MSAT

Therapist

• 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.

Associate Director, QC Operations – Cell Therapy

Learning and Development

• Ensure document control and training processes comply with cGxP, and applicable global regulations (FDA, EMA, ICH)
• Author, review, and maintain SOPs governing document control and training processes
• Support internal audits and regulatory inspections as necessary
• Track, trend, and report key quality metrics at Management Review
• Perform other project-related improvements to the QMS, DMS, or LMS as determined with management
• Influence quality culture by promoting documentation excellence and compliance awareness across Obsidian
• Own and manage the document control lifecycle for GxP documents
• Ensure timely authoring, review, approval, issuance, revision, archival, and obsolescence of controlled documents in accordance with regulatory requirements
• Support inspection readiness by ensuring document accuracy, traceability, version control, and rapid retrieval
• Lead the selection, validation, and implementation of an electronic Document Management System (eDMS)
• Create and administer training of the new eDMS to all stakeholders
• Own and administer the GXP training program, including onboarding, role-based, and recurring training
• Manage the Learning Management System (LMS), currently Compliance Wire, including curricula design, tracking, and reporting
• Ensure training content aligns with procedures, job roles, and regulatory expectations
• Monitor training compliance metrics and work with stakeholders to address overdue training
• Partner with stakeholders to define training requirements for new SOPs, roles, or systems
• Implement and manage training effectiveness evaluations on SOPs and courses

Senior Document Control and Training Manager

• Develop and implement a phase-appropriate QC strategy and operations for clinical and commercial stages of development to support external manufacturing of autologous cell therapy products ensuring compliance with regulations and alignment with applicable global standards.
• Serve as the QC subject matter expert (SME) for analytical methods, method qualification/validation, CMC strategy, regulatory filings, relationship management with external laboratory partners, and interactions with regulatory agencies. Ensure methods are fit-for-purpose, phase-appropriate, and robust for QC environments.
• Define analytical control strategies for drug substance (DS) and drug product (DP), raw materials, in-process controls (IPCs), and release testing.
• Champion continuous improvement to strengthen method lifecycle management, documentation practices, and analytical robustness.
• Partner with External Manufacturing and QA Operations to manage and oversee contract testing laboratories (CTLs) and CDMOs; lead method transfer, qualification, testing, validation, and lifecycle management in line with business needs and quality and regulatory standards.
• Support lot release and disposition decisions in collaboration with QA including QC input into Investigations and CAPAs, change controls (methods, specifications, materials), and stability programs.
• Review and approve internal and external documents (including laboratory investigations, deviations, CAPAs, SOPs, validations, reports, forms, specifications, and certificates of analysis).
• Interpret and present data, perform statistical analysis, and conduct trend assessments, participate in Quality Management Reviews.
• Author and/or review CMC documents pertinent to quality control for regulatory submissions.
• Lead QC support for Regulatory inspections for internal and external audits.
• Oversee QC assessment of new raw materials and raw material qualification required to support GMP manufacturing and testing.
• Establish department and individual goals and key performance indicators in alignment with company and operational goals.
• Proactively identify, assess, and mitigate quality, operational, and organizational risks; escalate key risks and issues.
• Develop and support a high performing team to execute department responsibilities; ensure effective utilization of resources through strong people leadership including consistent performance management, robust employee engagement and development, and philosophically aligned rewards and recognitions practices.
• Drive a team culture of high standards, collaboration, empowerment, accountability, trust, and continuous learning.

Senior Director, Quality Control

• Define and lead the overall Cell Orchestration governance system, including strategic and daily management oversight to ensure the highest level of service level for patients through cycle time optimization and network allocation.
• Lead the implementation of a Cell Orchestration solution to support pivotal and commercial phases.
• Coordinate and execute all logistics requirements across all GMP and non GMP material transfers
• Oversee logistics partners’ performance with a focus on quality, reliability, and cost-effectiveness.
• Develop and manage the department’s annual logistics budget based on program goals and enrollment plans; partner with Finance to analyze variances and implement adjustments.
• Establish performance metrics, KPIs, and escalation pathways to ensure operational excellence and partner accountability
• Support BLA-enabling supply chain activities, including Chain of Identify and Chain of Custody strategies, shipping validation and temperature monitoring strategies.
• Proactively identify, assess, and mitigate operational, quality, and organizational risks; escalate key risks and issues.
• Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability
• Partner with Technical Operations & Quality, Regulatory and Finance to ensure full compliance with GxP, GMP, and other regulatory requirements.
• Together with the VP, Global Supply Chain, identify opportunities to leverage AI capabilities of current systems in the near term, and a mid-to-long term strategy to leverage AI into cell orchestration and logistics as our programs advance.

Director, Manufacturing Science and Technology – MSAT

Associate Director, QC Operations – Cell Therapy

Senior Document Control and Training Manager

Senior Director, Quality Control

Director – Cell Orchestration and Logistics