Associate Director, Drug Product Development

🕒 Junho 12

🗽 New York – Remoto

🗽 New York – Remote

💵 $150.000 - $202.351 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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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 technical contact for CDMOs supporting drug product manufacturing and release activities • Lead oversight of drug product development activities, including process development, tech transfer, scale-up, and validation • Provide technical leadership for clinical and commercial drug product manufacturing campaigns, including review and approval of batch records, campaign plans, protocols, reports, and investigations as applicable • Partner with CDMOs to identify, assess, and mitigate process risks and manufacturing challenges, ensuring timely resolution of technical issues • Contribute to the development of process validation strategies for drug product manufacturing in collaboration with internal and external stakeholders • Oversee preparation, review, and approval of process validation documentation, including process performance qualification (PPQ) protocols/reports, risk assessments, control strategies, and continued process verification plans • Evaluate manufacturing performance data to identify trends, process capability concerns, and opportunities for continuous improvement • Lead secondary packaging development activities for a drug product in late-stage development • Support development of packaging design, component selection, labeling configuration inputs, packaging line considerations, and secondary packaging validation activities with external partners and internal stakeholders

🎯 Requisitos

• Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or a related discipline • 10+ years of relevant experience in pharmaceutical drug product development, manufacturing science, technical operations, or related CMC functions • Demonstrated experience supporting outsourced manufacturing models and managing CDMOs in a virtual company environment • Strong working knowledge of: • cGMP requirements for OSD manufacturing • Drug product process development, formulation development, tech transfer, scale-up, and PPQ • ICH Q8/Q9/Q10 and risk‑based validation principles • Manufacturing investigations and change management • Proven ability to technically oversee and influence external manufacturing partners.

🏖️ 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 and some fun fringe perks!