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 activitiesLead the drug product development and manufacturing strategy across assigned programs, including formulation development, process development, technology transfer, scale-up, process validation, and commercial readinessLead 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 documentationEstablish and manage CDMO technical governance, including meeting cadence, performance oversight, escalation pathways, risk management, and issue-resolution processesContribute to cross-functional CMC workstreams involving Pharmaceutical Development, Quality, Regulatory CMC, Analytical Development, Supply Chain, Clinical Supply, Program Management, and external manufacturing partnersDrive identification, assessment, prioritization, and mitigation of process risks, manufacturing challenges, and supply-readiness issues across internal and external stakeholdersOwn or co-own process validation strategy for drug product manufacturing, including PPQ strategy, risk assessments, control strategies, continued process verification plans, and lifecycle process monitoringLead 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 documentationEvaluate manufacturing performance data to identify trends, process capability concerns, technical risks, and continuous improvement opportunitiesProvide senior technical leadership for manufacturing investigations, deviation resolution, CAPA development, change controls, and post-approval manufacturing changesLead secondary packaging development activities for late-stage and commercial-readiness drug product programsOversee packaging design, component selection, labeling configuration inputs, packaging line considerations, packaging validation, and supply-readiness activities with external partners and internal stakeholdersSupport regulatory submissions, agency questions, inspection readiness, and PAI preparation related to drug product manufacturing, process validation, packaging, and CMC contentAuthor and/or review relevant CMC sections and technical documentation supporting regulatory submissions, health authority interactions, and lifecycle management activitiesManage external technical activities, priorities, budgets, timelines, and deliverables for CDMO partners and consultants supporting drug product and packaging developmentProvide technical recommendations to senior leadership on manufacturing strategy, CDMO performance, validation readiness, process risks, regulatory readiness, and commercialization decisionsMentor 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 preferredMinimum 12 years of relevant experience in pharmaceutical drug product development, manufacturing science, technical operations, CMC, or related functionsSignificant experience leading outsourced manufacturing models and managing CDMOs in a virtual or highly outsourced company environmentDemonstrated experience providing technical leadership for drug product development, technology transfer, scale-up, process validation, and commercial readinessStrong working knowledge of:cGMP requirements for OSD manufacturingDrug product process development, formulation development, technology transfer, scale-up, PPQ, and CPVICH Q8/Q9/Q10 and risk-based validation principlesManufacturing investigations, deviations, CAPAs, and change managementRegulatory expectations for late-stage development, commercial readiness, and inspection preparednessProven ability to technically oversee, influence, and hold external manufacturing partners accountable for quality, timelines, technical execution, and issue resolutionDemonstrated ability to lead cross-functional teams and influence senior internal and external stakeholders without relying solely on direct authorityExperience contributing to CMC strategy for regulatory submissions, health authority questions, PAIs, or commercial launch readinessStrong analytical, communication, documentation, and decision-making skillsAbility 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 productsExperience with lifecycle management, CPV programs, post-approval change management, and commercial manufacturing supportExperience authoring and reviewing CMC sections for regulatory submissions related to drug product manufacturing, validation, and packagingFamiliarity with statistical tools used for process monitoring, process capability assessment, CPV, and manufacturing data analysisExperience mentoring technical staff in a pharmaceutical development, technical operations, or CMC environment 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 dependents401(k) program with company match and vesting after the turn of the first month after your start dateFlexible time offGenerous parental leave and some fun fringe perks! The starting base pay range for this position: $230,000—$260,000 USD