Senior Process Engineer, Drug Substance

Vaga não está no LinkedIn

🕒 Outubro 9

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $110.000 - $125.000 / ano

⏰ Tempo Integral

🟠 Sênior

👷🏻‍♀️ Engenheiro

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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

• Work closely with Contract Manufacturing Organizations (CMOs) to support and validate processes for manufacturing small molecule Active Pharmaceutical Ingredients (APIs) • Support future commercial production and help ensure appropriate supply levels • Maintain day-to-day communications with CMOs • Contribute to knowledge transfer activities between Praxis and CMOs • Understand written chemical synthesis processes from lab partners • Translate synthesis processes into industrial execution instructions by authoring scale-up spreadsheets and process manuals • Gather, analyze, and archive large data packages for regulatory filings • Review CMO and lab partner documentation, including instructions, procedures, batch records, non-conformances, in-process controls, certificates of analysis, and developmental reports • Work alongside Quality Assurance to ensure regulations and standards are followed by third parties • Adhere to industry guidelines, standards, laws, and cGMPs • Identify and escalate process risks and support mitigation plans • Travel to and participate in person-in-plant activities at CMOs in the US and worldwide

🎯 Requisitos

• Bachelor’s or advanced degree in chemical engineering or another relevant engineering field; MS or equivalent is a plus • Pharmaceutical or fine chemical industry experience required • 4–8 years of applied experience in CMO management, chemical manufacturing, or comparable positions handling diverse chemical syntheses in laboratory and manufacturing environments • Experience reviewing manufacturing and executed batch records, operating procedures, non-conformances, and change controls • Experience supporting business partner relationships • Ability to understand written chemical synthesis processes and translate them into industrial execution instructions • Ability to use technologies and applications to gather, analyze, and archive large data packages supporting regulatory filings • Knowledge of cGMPs, industry guidelines, standards, and laws • Excellent written and visual communication skills • Ability to build relationships internally and externally • Self-motivated and able to contribute to a productive, collaborative team environment • Highly organized and detail-oriented • Willingness and flexibility to travel as needed, including in-person in-plant activities at CMOs in the US and worldwide • Comfort with regular computer/device use, screen work, basic hand coordination, clear communication, and focus

🏖️ 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 • Reasonable accommodations for individuals with disabilities

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