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 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!

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

Provide senior technical leadership for manufacturing investigations, deviation resolution, CAPA development, change controls, and post-approval manufacturing changes

Lead secondary packaging development activities for late-stage and commercial-readiness drug product programs

Oversee packaging design, component selection, labeling configuration inputs, packaging line considerations, packaging validation, and supply-readiness activities with external partners and internal stakeholders

Support regulatory submissions, agency questions, inspection readiness, and PAI preparation related to drug product manufacturing, process validation, packaging, and CMC content

Author and/or review relevant CMC sections and technical documentation supporting regulatory submissions, health authority interactions, and lifecycle management activities

Manage external technical activities, priorities, budgets, timelines, and deliverables for CDMO partners and consultants supporting drug product and packaging development

Provide technical recommendations to senior leadership on manufacturing strategy, CDMO performance, validation readiness, process risks, regulatory readiness, and commercialization decisions

Mentor and provide technical guidance to junior team members, consultants, and cross-functional partners involved in drug product development and manufacturing activities

Required Qualifications

Bachelors’ degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or a related discipline; advanced degree preferred

Minimum 12 years of relevant experience in pharmaceutical drug product development, manufacturing science, technical operations, CMC, or related functions

Significant experience leading outsourced manufacturing models and managing CDMOs in a virtual or highly outsourced company environment

Demonstrated experience providing technical leadership for drug product development, technology transfer, scale-up, process validation, and commercial readiness

Strong working knowledge of:

cGMP requirements for OSD manufacturing

Drug product process development, formulation development, technology transfer, scale-up, PPQ, and CPV

ICH Q8/Q9/Q10 and risk-based validation principles

Manufacturing investigations, deviations, CAPAs, and change management

Regulatory expectations for late-stage development, commercial readiness, and inspection preparedness

Proven ability to technically oversee, influence, and hold external manufacturing partners accountable for quality, timelines, technical execution, and issue resolution

Demonstrated ability to lead cross-functional teams and influence senior internal and external stakeholders without relying solely on direct authority

Experience contributing to CMC strategy for regulatory submissions, health authority questions, PAIs, or commercial launch readiness

Strong analytical, communication, documentation, and decision-making skills

Ability to operate independently in a fast-paced, virtual biotech or pharmaceutical environment with significant external partner reliance

Preferred Qualifications

Experience supporting regulatory submissions and PAIs for solid oral dosage products

Experience with lifecycle management, CPV programs,