Director, Pharmaceutical Development – Drug Product Manufacturing

🕒 Setembro 30

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $230.000 - $260.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

👻 Score fantasma 4%

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Definium Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2019

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

Healthcare • Biotechnology • Pharmaceuticals

A Definium Therapeutics é uma empresa de biotecnologia em estágio clínico, desenvolvendo terapias de precisão derivadas de psicodélicos para distúrbios psiquiátricos e neurodesenvolvimentais. A empresa foca em formulações farmacêuticas otimizadas de lisergida (LSD) e um R-enantiômero de MDMA para tratar condições como transtorno depressivo maior, transtorno de ansiedade generalizada e sintomas centrais do transtorno do espectro autista, avançando candidatos através de ensaios pré-clínicos e clínicos com uma abordagem científica e baseada em evidências.

Descrição

• Serve as the senior technical lead and primary point of contact for CDMOs supporting drug product manufacturing, packaging, testing, and release activities • Lead 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 with 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 • Own or co-own process validation strategy, including PPQ strategy, risk assessments, control strategies, CPV plans, and lifecycle process monitoring • Lead preparation, review, and approval of process validation 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 • 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 CMC sections and technical documentation supporting regulatory submissions, health authority interactions, and lifecycle management • Manage external technical activities, priorities, budgets, timelines, and deliverables for CDMO partners and consultants • 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

🎯 Requisitos

• 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 • Preferred: experience supporting regulatory submissions and PAIs for solid oral dosage products • Preferred: experience with lifecycle management, CPV programs, post-approval change management, and commercial manufacturing support • Preferred: experience authoring and reviewing CMC sections for regulatory submissions related to drug product manufacturing, validation, and packaging • Preferred: familiarity with statistical tools used for process monitoring, process capability assessment, CPV, and manufacturing data analysis • Preferred: experience mentoring technical staff in a pharmaceutical development, technical operations, or CMC environment

🏖️ Benefícios

• 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 • Additional compensation, including bonus and equity, may be available