Senior Manager, Analytical Sciences – Commercial

Vaga não está no LinkedIn

🕒 Junho 23

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $147.000 - $167.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 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

• Define and execute analytical strategies for commercial products, ensuring methods, specifications, and control strategies remain compliant, robust, and fit for purpose. • Lead method transfer, validation, and lifecycle management activities, identifying opportunities for improvement and supporting post-approval changes. • Provide analytical leadership for PPQ, CPV, commercial manufacturing, and stability programs, ensuring reliable data, product quality, and regulatory compliance. • Review and approve analytical documentation, including protocols, reports, specifications, method validations, Certificates of Analysis, raw data, chromatographic integrations, and audit trails. • Oversee analytical execution at CDMOs, ensuring timely, compliant deliverables that support product release, supply continuity, and inspection readiness, including on-site support during critical campaigns and inspections. • Lead analytical investigations involving OOS/OOT results, deviations, complaints, and CAPAs, driving root cause determination and technical recommendations consistent with FDA and EU GMP expectations. • Assess analytical risks associated with manufacturing, supply chain, and process changes, ensuring appropriate impurity controls and lifecycle management strategies are maintained. • Author and review technical reports, Annual Product Reviews (APR/PQRs), regulatory submissions, post-approval changes, and responses to health authorities. • Serve as the analytical SME, partnering with Quality, Regulatory, Manufacturing, and CMC teams to support compliant commercial operations and informed decision-making.

🎯 Requisitos

• Bachelor’s degree in Chemistry or related discipline with 10+ years of relevant experience; Master’s degree with 7+ years of experience may be considered. • Experience supporting commercial small molecule drug substance and/or drug product programs; analytical development experience preferred. • Strong expertise in analytical method transfer, validation, troubleshooting, and lifecycle management within GMP environments. • Technical knowledge of small molecule drug substances and oral dosage forms, including solid oral and liquid/reconstituted products. • Demonstrated 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 managing commercial analytical methods and control strategies, including evaluating and implementing method improvements. • Working knowledge of US and EU cGMP requirements and applicable ICH guidelines, including impurity and mutagenic impurity guidance. • Experience supporting regulatory submissions, post-approval changes, and health authority inspections; direct FDA or EMA inspection support experience preferred. • Proven ability to build productive partnerships with CDMOs and external service providers while driving accountability and results. • The physical and mental requirements of this role include regular use of a computer, mobile devices, and office equipment; clear communication; and occasional travel to laboratory, manufacturing, and office environments.

🏖️ Benefícios

• Diversity, Equity & Inclusion initiatives • Professional development opportunities