Director, Process Chemistry

Vaga não está no LinkedIn

🕒 Agosto 4

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $215.000 - $235.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Praxis

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2002

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

A Praxis é uma empresa dedicada a conectar pacientes com oportunidades significativas de ensaios clínicos. Com foco na criação de programas de recrutamento personalizados, a Praxis utiliza uma variedade de ferramentas especializadas e vasta experiência em diversas áreas terapêuticas para garantir que alcancem os pacientes certos em todo o mundo. Estabelecida em 2002, a empresa enfatiza a importância do engajamento do paciente e utiliza insights sofisticados de dados para aprimorar a jornada do paciente na pesquisa clínica.

Descrição

• Lead drug substance activities for one or more small molecule programs from early development through commercial readiness • Design early-phase and late-phase/commercial drug substance processes and lead their demonstration from laboratory to pilot plant • Lead Process Chemistry research and development across project phases • Provide chemistry and technical leadership throughout the product lifecycle • Participate in or lead identification of final API forms for pharmaceutical development • Collaborate with formulation, analytical, operations, engineering and quality teams on clinical and commercial drug substance delivery • Identify, collaborate with and lead external CRO and CDMO organizations to achieve deliverables • Analyze external experimental data to drive synthetic experimental plans at CROs and CDMOs • Author or co-author regulatory submissions • Define manufacturing strategy and execution, including GMP requirements and issue resolution • Assess and apply new trends and concerns in process development, quality and manufacturing • Manage quarterly budgeting for drug-substance activities • Contribute to inventions that strengthen Praxis’ intellectual property position

🎯 Requisitos

• Advanced degree or commensurate experience equivalent in Chemistry, Pharmaceutical Sciences, Engineering or related discipline • Minimum of 12 years of industry experience in CMC specifically for small molecule drug substance • Scientific track record or working knowledge in continuous processing, biocatalysis, catalysis, and/or high throughput experimentation desirable • Strong knowledge of US and EU cGMP requirements and best practices relating to drug substances and drug products • Strong knowledge of CMC development across all phases of drug development from initial regulatory filings through registration, validation and launch • Experience working with third-party CRO/CMO partners and associated service providers to develop and manufacture pharmaceutical products • Experience with salt/crystalline form selection preferred • Experience with oligonucleotide chemistry is a plus • High level of intellectual curiosity, innovation, creative problem solving and entrepreneurial spirit; ability to thrive in an agile environment • Excellent interpersonal and communication skills, with ability to develop important relationships that include trust and encourage diversity • Highly organized and detail-oriented with a passion to deliver quality results

🏖️ Benefícios

• 99% of the premium paid for medical, dental and vision plans • Company-paid life insurance • AD&D benefits • Disability benefits • Voluntary plans to personalize coverage • Dollar-for-dollar 401(k) match up to 6% on eligible contributions • Long-term stock incentives • ESPP • Discretionary quarterly bonus • Extremely flexible wellness benefit • Generous PTO • Paid holidays • Company-wide shutdowns