Director, Pharmaceutical Development, Drug Product Manufacturing
About The Position
Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on developing accessible treatments using psychedelics for psychiatric disorders. Our lead candidate targets anxiety, depression, and PTSD, while a pipeline candidate addresses autism spectrum disorder. We aim to advance mental health care by addressing the underlying causes of psychiatric and neurological disorders. Headquartered in New York and trading on Nasdaq (DFTX), we are seeking to move psychiatry forward. This role is a key technical and strategic leadership position within Pharmaceutical Development, overseeing outsourced drug product development and manufacturing. Responsibilities include managing early- and late-phase development, commercial readiness, and lifecycle management. The Director will be the primary technical and strategic lead for Contract Development and Manufacturing Organizations (CDMOs), defining, planning, and driving manufacturing activities from formulation and process development through technology transfer, validation, and commercial supply. The role requires deep technical expertise in drug product development, formulation, technology transfer, scale-up, process validation, and continued process verification, along with senior-level oversight in a virtual manufacturing environment. The Director will lead CDMO governance, influence CMC strategy, and ensure alignment with program timelines, quality, regulatory requirements, and commercial objectives. Additionally, the role involves leading secondary packaging development for late-stage and commercial-readiness programs, ensuring alignment of design, qualification, supply, labeling, validation, and execution.
Requirements
- 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
- Strong working knowledge of: Drug product process development, formulation development, technology transfer, scale-up, PPQ, and CPV
- Strong working knowledge of: ICH Q8/Q9/Q10 and risk-based validation principles
- Strong working knowledge of: Manufacturing investigations, deviations, CAPAs, and change management
- Strong working knowledge of: 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
Nice To Haves
- Experience supporting regulatory submissions and PAIs for solid oral dosage products
- Experience with lifecycle management, CPV programs, post-approval change management, and commercial manufacturing support
- Experience authoring and reviewing CMC sections for regulatory submissions related to drug product manufacturing, validation, and packaging
- Familiarity with statistical tools used for process monitoring, process capability assessment, CPV, and manufacturing data analysis
- Experience mentoring technical staff in a pharmaceutical development, technical operations, or CMC environment
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
Benefits
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and vesting after the turn of the first month after your start date
- Flexible time off
- Generous parental leave
- some fun fringe perks!
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What This Job Offers
Job Type
Full-time
Career Level
Director
