Director, Supply and Distribution Quality

The posting, as Definium Therapeutics wrote it

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.

Responsibilities

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
[…]
ity systems, DSCSA, and applicable Good Distribution Practice principles.

• Experience with supplier oversight, quality agreements, audits, quality events, CAPA, change control, complaints, and inspection readiness.
• Experience with serialization, traceability-data exchange, suspect-product processes, or related product-security controls.
• Demonstrated ability to make risk-based Quality decisions and influence senior leaders and external partners without direct operational authority.
• Experience working with distribution of Controlled Substances
• Ability to travel approximately 15%, with periodic increases during launch, significant investigations, partner qualifications, or regulatory inspections.

Preferred Qualifications

• Experience with commercial product launch, 3PL implementation, distribution-lane qualification, mock recalls, and initial market supply.
• Experience with serialization or traceability platforms
• Experience supporting FDA, state Board of Pharmacy, or other regulatory inspections involving commercial distribution, licensing, packaging, or product traceability.
• Experience with small-molecule oral solid dosage products.
• Familiarity with state pharmaceutical licensing, NABP programs, EPCIS, or artwork-management platforms.

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:

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and vesting after the turn of the first month after your start date
• Flexible time off
• Generous parental leave and some fun fringe perks!