Senior Manager, Analytical Sciences – Commercial

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🕒 vor 2 Tagen

🇺🇸 Vereinigte Staaten – Remote

💵 $147.000 - $167.000 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Manager

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Praxis

WebsiteLinkedInAlle Stellen

11 - 50 Mitarbeiter

Gegründet 2002

🧬 Biotechnologie

⚕️ Krankenversicherung

🔬 Wissenschaft

Biotechnology • Healthcare Insurance • Science

Praxis ist ein Unternehmen, das sich darauf spezialisiert hat, Patienten mit bedeutenden Möglichkeiten in klinischen Studien zu verbinden. Mit dem Schwerpunkt auf maßgeschneiderten Rekrutierungsprogrammen nutzt Praxis eine Vielzahl spezialisierter Werkzeuge und umfangreiche Erfahrung in verschiedenen therapeutischen Bereichen, um sicherzustellen, dass sie weltweit die richtigen Patienten erreichen. Das 2002 gegründete Unternehmen legt großen Wert auf die Einbindung von Patienten und nutzt ausgeklügelte Datenanalysen, um die Patientenerfahrung in der klinischen Forschung zu verbessern.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

• Diversity, Equity & Inclusion initiatives • Professional development opportunities