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Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale.
Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges.
Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.
Together we are moving psychiatry forward—beyond better, into a boundless future. Join us!
The Director, Commercial Supply Quality is the Quality lead for outsourced commercial packaging, labeling, storage, transportation, distribution, serialization, and product-traceability activities. This role is a critical hire that will support readiness of launch stock and ongoing supply.
This role provides Quality oversight of contract manufacturing organizations (CMOs), contract packaging organizations (CPOs), third-party logistics providers (3PLs), distributors, carriers, and related technology providers. The Director ensures that the commercial supply network operates in compliance with cGMP, applicable Good Distribution Practice principles, the Drug Supply Chain Security Act (DSCSA), approved procedures, and quality agreements.
Working across Quality, Supply Chain, Pharmaceutical Development, Regulatory Affairs, Trade & Distribution, Information Technology, and external partners, the Director establishes risk-based governance, supports commercial launch and ongoing supply, manages significant quality and product-security risks, and maintains inspection readiness across the external network.
Commercial Packaging & Labeling Quality
Provide Quality ownership and leadership for commercial packaging and labeling activities performed by CMOs and CPOs from launch readiness through post-approval lifecycle management
Serve as the Quality relationship owner for packaging and labeling partners, including governance, performance monitoring, quality-event escalation, investigation oversight, CAPA follow-up, and product-impact assessment
Provide Quality approval of packaging artwork and labeling components for GMP compliance, version control, implementation accuracy, reconciliation, and change control; Regulatory Affairs retains approval of regulatory content
Oversee Quality readiness and lifecycle management for outsourced packaging and labeling, including artwork implementation, component qualification, line trials, process validation, serialization, reconciliation, and change control
Reviews final batch/packaging records and makes final batch dispositions/release to market
Distribution, Logistics & 3PL Quality
Act as the Quality lead for storage, transportation, returns, destruction, and distribution (including reverse logistics) activities performed through the outsourced commercial network
Lead Quality readiness for commercial launch across 3PL onboarding, distribution-lane qualification, returns processing, traceability-data exchange, mock recall capability, and initial market supply
Establish risk-based oversight of 3PLs, distributors, carriers, depots, storage facilities, transportation lanes, equipment, and supporting systems, including qualification, validation, performance monitoring, periodic review, and inspection readiness
Oversee logistics-related quality events, including temperature excursions, shipment damage, loss, theft, diversion, security events, and delivery exceptions; and coordinate investigation, product-impact assessment, escalation, and disposition with functional area owners
Serve as the Supply Quality lead for recalls, mock recalls, distribution holds, market actions, and returns; including management of any resulting dispositions
DSCSA, Serialization & Product Traceability
Lead the company’s DSCSA Quality compliance program and ensure that requirements applicable to the company’s role in the pharmaceutical distribution supply chain are incorporated into the Quality Management System
Establish controls for authorized trading-partner verification, electronic transaction-data exchange, serialization, aggregation, verification, exception management, reconciliation, and record retention
Provide Quality governance for serialization and traceability platforms in partnership with Supply Chain and Trade & Distribution
Lead or oversee suspect and illegitimate product investigations, including quarantine, verification, trading-partner communication, disposition, corrective action, and required regulatory notification
Monitor evolving regulatory requirements and industry standards and translate applicable changes into procedures, training, partner expectations, and readiness plans
Quality Systems, Partner Governance & Inspection Readiness
Own and continuously improve company procedures governing packaging quality, distribution quality, product traceability, returns, suspect product, and related quality events
Serve as the Quality relationship owner for in-scope commercial supply partners while working through the company’s established supplier qualification, audit, approved-supplier, and quality-agreement processes
Provide quality representation for recurring external partner meetings and leads quality portion of business review meetings
Lead company inspection readiness and provide Quality representation or partner-site support for FDA, state licensing authority, Board of Pharmacy, and other inspections involving packaging, distribution, traceability, or DSCSA processes.
Ensure significant quality events across the commercial supply network are promptly escalated, investigated, assessed for product and compliance impact, and addressed through effective corrective and preventive actions
Track, trend, and report meaningful quality and compliance indicators to senior leadership and Management Review, including partner performance, shipment exceptions, traceability exceptions, investigations, CAPAs, and recurring risks
Leadership & Cross-Functional Partnership
Establish functional strategy, priorities, performance indicators, and resource plans aligned with launch and ongoing commercial supply objectives
Influence internal stakeholders and external partners through clear governance, risk-based decision-making, and effective escalation
Requirements:
Preferred Qualifications
The starting base pay range for this position is $180,000.00-215,000.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.
Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:
