Director, Pharmaceutical Development, Drug Product Manufacturing

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 leadproductcandidate,lysergidetartrate(ourproprietary orally disintegrating tablet form oflysergide(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 bythe recognitionthat patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to addresstheunderlying 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.

A key technical and strategic leader within the Pharmaceutical Development organization, responsible for leading outsourced drug product development and manufacturing activities across early- and late-phase development, commercial readiness, and lifecycle management. This individual will serve as the primary technical and strategic lead for CDMO partners supporting drug product manufacturing and testing, and will be accountable for defining, planning, coordinating, and driving manufacturing-related activities from formulation and process development through technology transfer, process validation, continued process verification, and commercial supply readiness.

This role requires deep technical expertise in drug product process development, formulation development, technology transfer, scale-up, process validation, and continued process verification, combined with the ability to provide senior-level oversight in a virtual manufacturing environment. The Director will lead CDMO governance and technical decision-making, influence cross-functional CMC strategy, and ensure that external manufacturing partners are aligned with program timelines, quality expectations, regulatory requirements, and commercial-readiness objectives.

The Director will also lead secondary packaging development activities in support of late-stage and commercial-readiness programs, ensuring alignment of packaging design, qualification, supply readiness, labeling configuration, validation, and execution within program timelines and regulatory expectations.

Key Responsibilities

• Serve as the senior technical lead and primary point of contact for CDMOs supporting drug product manufacturing, packaging, testing, and release activities
• Lead the drug product development and manufacturing strategy across assigned programs, including formulation development, process development, technology transfer, scale-up, process validation, and commercial readiness
• Lead technical oversight of clinical and commercial drug product manufacturing campaigns, including review and approval of batch records, campaign plans, protocols, reports, deviations, investigations, and associated technical documentation
• Establish and manage CDMO technical governance, including meeting cadence, performance oversight, escalation pathways, risk management, and issue-resolution processes
• Contribute to cross-functional CMC workstreams involving Pharmaceutical Development, Quality, Regulatory CMC, Analytical Development, Supply Chain, Clinical Supply, Program Management, and external manufacturing partners
• Drive identification, assessment, prioritization, and mitigation of process risks, manufacturing challenges, and supply-readiness issues across internal and external stakeholders
• Own or co-own process validation strategy for drug product manufacturing, including PPQ strategy, risk assessments, control strategies, continued process verification plans, and lifecycle process monitoring
• Lead preparation, review, and approval of process validation documentation, including PPQ protocols and reports, validation master plans, risk assessments, control strategies, CPV plans, and associated regulatory-supporting documentation
• Evaluate manufacturing performance data to identify trends, process capability concerns, technical risks, and continuous improvement opportunities