Definium Therapeutics develops psychedelic-based therapeutics for psychiatric and neurological disorders. Backed by North Carolina Biotechnology Center.
About the role
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.
What they're looking for
- Bachelor’s degree in life sciences, engineering, pharmacy, supply chain, or a related discipline
- minimum 10 years of progressive commercial pharmaceutical or biotechnology GMP Quality Assurance experience, including leadership of commercial supply, external partner, and cross-functional quality programs
- Demonstrated experience overseeing CMOs, CPOs, 3PLs, distributors, carriers, or other external supply partners
- Strong working knowledge of pharmaceutical cGMP, packaging and labeling controls, commercial distribution quality 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
More about this role
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...
Browse similar: Startup jobs · Remote jobs