Manager, Analytical Sciences – Commercial

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🕒 5 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $115.000 - $140.000 / ano

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

👔 Gerente

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

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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

• Execute analytical strategies for commercial products, ensuring methods, specifications, and control strategies remain compliant and fit for purpose • Lead method transfer, validation, and lifecycle management activities, identifying risks and driving resolution • Support analytical activities for PPQ, CPV, commercial manufacturing, and stability programs • Review and approve analytical documentation, including protocols, reports, specifications, method validations, CoAs, raw data, chromatographic integrations, and audit trails • Manage analytical activities at CDMOs, ensuring compliant, timely deliverables supporting product release, supply continuity, and inspection readiness • Provide on-site support during critical campaigns and inspections • Lead or support analytical investigations involving OOS/OOT results, deviations, and CAPAs, performing root cause analysis and supporting quality decisions • Assess analytical risks associated with manufacturing, supply chain, and process changes • Contribute to regulatory submissions, post-approval changes, Annual Product Reviews (APR/PQRs), and health authority responses • Serve as an analytical SME, partnering with Quality, Regulatory, Manufacturing, and CMC teams

🎯 Requisitos

• Bachelor’s degree in Chemistry or related discipline • 7+ years of analytical chemistry experience in a GMP-regulated environment • Experience supporting commercial small molecule drug substance and/or drug product programs • Strong technical knowledge of small molecule drug substances and oral dosage forms, including solid oral and liquid/reconstituted products • Experience with analytical method transfer, validation, and lifecycle management in GMP environments • Ability to review analytical data, chromatographic integrations, and electronic audit trails in accordance with ALCOA+, 21 CFR Part 11, and EU GMP Annex 11 requirements • Experience supporting commercial analytical methods and control strategies, including post-approval changes and method improvements • Working knowledge of US and EU cGMP requirements and applicable ICH guidelines • Ability to troubleshoot analytical testing issues and partner with QC laboratories, CDMOs, and external service providers • Regular use of a computer, devices or other office equipment; clear communication; occasional movement; comfort with screen work, basic hand coordination, and focus

🏖️ Benefícios

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