Saskia Van Brenk Email & Phone Number

Oss

🌿 Overview:Offering expert CMC (Chemistry, Manufacturing, and Controls) support for a leading biological drug substance manufacturing facility and external manufacturing sites, including CMOs (Contract Manufacturing Organizations).💡 Key Responsibilities:Global Collaboration: Collaborating seamlessly with HQ-CMC, international CMC teams, and Country Regulatory Affairs worldwide to ensure alignment and compliance.Change Control and Deviations: Conducting thorough… Show more 🌿 Overview:Offering expert CMC (Chemistry, Manufacturing, and Controls) support for a leading biological drug substance manufacturing facility and external manufacturing sites, including CMOs (Contract Manufacturing Organizations).💡 Key Responsibilities:Global Collaboration: Collaborating seamlessly with HQ-CMC, international CMC teams, and Country Regulatory Affairs worldwide to ensure alignment and compliance.Change Control and Deviations: Conducting thorough regulatory impact assessments for change controls and deviations, facilitating smooth transitions while maintaining compliance.Batch Disposition Support: Providing crucial support by addressing batch disposition queries from internal manufacturing sites and CMOs, ensuring product quality and regulatory standards are met. Show less

Nuland

🎯 Primary Focus:Specialized in CMC (Chemistry, Manufacturing, and Controls) for small molecules, biologicals, vaccines, and combination products.📋 Key Responsibilities:Dossier Management: Expertly manage the preparation of BLA/MAA submission and post-approval variation dossiers, overseeing coordination and authoring processes.Global Regulatory Strategies: Development and execution of regulatory submission strategies for both initial submissions and post-approval… Show more 🎯 Primary Focus:Specialized in CMC (Chemistry, Manufacturing, and Controls) for small molecules, biologicals, vaccines, and combination products.📋 Key Responsibilities:Dossier Management: Expertly manage the preparation of BLA/MAA submission and post-approval variation dossiers, overseeing coordination and authoring processes.Global Regulatory Strategies: Development and execution of regulatory submission strategies for both initial submissions and post-approval variations.Post-Approval Variation Projects: Successfully manage post-approval variation projects, especially site changes for drug substance and drug product.Health Authority Communications: Prepare and present communications to Health Authorities worldwide, including scientific advice and responses to inquiries.Customer and Regulatory Services: Act as a representative for both customers and regulatory services, ensuring a seamless interface between the two.Team Development: Coach and mentor Junior Regulatory Affairs Managers, contributing to their professional growth. Show less

Utrecht

TMC is a public company that employs highly educated specialists in long term relationships in high tech, highly innovative companies on a consultant basis.

Best, The Netherlands

Oss, Netherlands

Oss, Netherlands

Assist clinical productionProcess upscalingProduct and process optimalization

Oss, Netherlands

Performance Qualification of new extrusion equipmentProcess Validation of pharmaceutical production process - extrusion technology

Swords, Ireland

Review and Remediation of Process Validation Documentation

Oss, Netherlands

Oss, Netherlands

Eindhoven, Netherlands

Oss, Netherlands

Wageningen, Netherlands

Bachelor'S Degree, Chemical Engineering

Secondary School - Havo, Science + French