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Nitrosamine - Project Management

Novintix Technologies Limited • Remote, US • published 2026-10-17 08:22:26.638711

Description

**About the Company:** NovintiX is a global engineering and digital transformation company with operations across multiple countries that helps leading organizations build innovative products and solve complex business challenges. We work across industries such as Medical Devices, Life Sciences, Healthcare and Manufacturing, delivering engineering, digital, and consulting solutions. **Project Manager – Biotherapeutics Nitrosamine Assessment** **Role Summary** The Project Manager will coordinate the initial cross\-functional assessment of nitrosamine risk for biotherapeutic products, including proteins and cell and gene therapies. The immediate objective is to determine whether existing paper\-based risk assessments and supporting documentation remain adequate against current regulatory expectations, and to define any evidence gaps, potential follow\-up work, and an indicative scope and resource estimate. **Key Responsibilities** * **Stakeholder coordination**: Partner with the designated Biotherapeutics leads to identify and engage the relevant drug substance, drug product, MSAT Material Sciences, and R\&D Material Sciences SMEs, keeping outreach focused on the assessment. * **Asse...

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