Associate Director, Technical Operations – CMC Strategy

🕒 2 dias atrás

🏄 California – Remoto

🏄 California – Remote

💵 $150.000 - $195.000 / ano

⏰ Tempo Integral

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Travere Therapeutics

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2013

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Travere Therapeutics é uma empresa biofarmacêutica comprometida em identificar, desenvolver e fornecer terapias que mudam vidas para pessoas que vivem com doenças raras, particularmente aquelas relacionadas a distúrbios renais e metabólicos raros. A empresa tem um forte foco no avanço da ciência nesses campos, com um pipeline que inclui tratamentos para condições como nefropatia por IgA e glomeruloesclerose segmentar focal. Com a aprovação completa da FDA dos EUA para seu tratamento não imunossupressor para nefropatia por IgA, a Travere Therapeutics continua a estabelecer novos padrões de cuidados. A empresa colabora com a comunidade de doenças renais raras, incluindo organizações de defesa dos pacientes e pesquisadores de ensaios clínicos, para trazer esperança aos pacientes com essas condições graves.

Descrição

• Provide strategic and technical leadership for technology transfer, scale-up, and cGMP manufacturing activities, ensuring timely resolution of technical issues across Phase I–III clinical and commercial products • Oversee formulation development of current approved drugs and new drug candidates • Manage and provide technical oversight of formulation development and cGMP manufacturing activities at contract manufacturing organizations (CMOs) • Support creation of integrated CMC development plans, timelines, budgets, risk assessments, and mitigation strategies to support clinical and commercial milestones • Managing CMOs to develop and maintain methods for clinical/commercial production of finished dosage forms • Review and approve technical and GMP documentation, including specifications, Master Batch records, validation documents, change controls, and technical reports • Author, edit, review, and contribute to CMC sections of regulatory submissions, responses, and health authority interactions • Partner closely with Regulatory Affairs, Quality, Supply Chain, Clinical Operations, and Program Management to ensure alignment of CMC activities with development and commercialization goals • Support regulatory inspections, partner audits, and ongoing compliance with applicable cGMP and global regulatory requirements • Provide technical leadership, mentorship, and strategic guidance across Technical Operations and cross-functional teams • Support launch readiness and commercialization planning to ensure reliable product supply

🎯 Requisitos

• Bachelor’s degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related discipline required • 8+ years of relevant experience in cGMP related CMC drug development and manufacturing with emphasis on late-phase clinical development, scale-up, and commercialization • Expert knowledge and extensive CMC experience advancing small molecule APIs from process development through process characterization, PPQ, commercialization, and tech transfers in support of solid oral dosage form programs • Demonstrated leadership experience in CMC: preferably in more than one related CMC area, and drug development experience with small molecules (both oral and injectable), peptides, and biologics of varying degrees of complexity • Extensive experience managing global CMOs, third-party manufacturers, and testing labs • Broad knowledge and experience with phase-appropriate cGMP requirements and applicable US, EU, and ICH guidelines • Demonstrated ability to prepare and review CMC sections of regulatory filings, including INDs, IMPDs, and NDAs • Manufacturing experience with oral solid dosage forms • Expert knowledge in process validation and technology transfer procedures

🏖️ Benefícios

• premium health • financial, work-life and well-being offerings for eligible employees and dependents • wellness and employee support programs • life insurance • disability • retirement plans with employer match • generous paid time off