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! 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:
What they're looking for
- Bachelor’s degree in life science, engineering, computer science or related field, or equivalent experience
- Minimum 6 years of computer system validation experience in an FDA-regulated pharmaceutical or biotechnology environment
- Direct participation in at least one FDA or EMA inspection, or in a formal inspection readiness program, including back-room support
- Hands-on validation of cloud or SaaS applications, including vendor-managed release cycles
- Working knowledge of 21 CFR Part 11, 21 CFR Parts 210/211, 312 and 314, EU GMP Annex 11, GAMP 5 and FDA data integrity guidance
- Strong technical writing skills, with a record of producing clear, inspection-ready validation documentation
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...
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