Brian Mølgaard Ness Email & Phone Number

Sorø, Dk

Kalundborg

Associate manager for 14 Packaging supporters covering 3 packaging lines.

Kalundborg, Zealand, Denmark

Led a process support team in aseptic production, managing 18 professionals responsible for process support, equipment maintenance, facility management, and shutdown coordination. Key areas of responsibility included facility support, Circular for Zero initiatives, clean and industrial utilities, HVAC systems, and overall shutdown management.Key achievements:Leadership & Team Management: - Successfully managed a team of 18 professionals, ensuring seamless operations across… Show more Led a process support team in aseptic production, managing 18 professionals responsible for process support, equipment maintenance, facility management, and shutdown coordination. Key areas of responsibility included facility support, Circular for Zero initiatives, clean and industrial utilities, HVAC systems, and overall shutdown management.Key achievements:Leadership & Team Management: - Successfully managed a team of 18 professionals, ensuring seamless operations across process support, equipment maintenance, and facility management.Energy & Water Efficiency: - Achieved a 5% reduction in energy and water consumption for the facility by implementing targeted optimizations, contributing to sustainability goals.Project Management: - Led several major projects, including the establishment of a UPS system, the implementation of Annex 1 requirements for gowning areas, and the replacement of the facility’s BMS and FMS systems.Risk Coordination: - Appointed as CVP Risk Coordinator, overseeing risk management processes and ensuring compliance with industry standards and regulations.Facility & Utility Management: - Provided comprehensive support across all facility-related processes, including Circular for Zero initiatives, clean and industrial utilities, and HVAC systems, ensuring high standards of operational efficiency. Show less

Kalundborg, Zealand, Denmark

Led a multidisciplinary process support team within API production, overseeing SIP, CIP, HVAC, Environmental Monitoring, and Clean and Industrial Utilities. Managed a team of 11 academics and technicians, focusing on continuous improvement, people development, and process optimization.Key achievements:Leadership & Team Management: - Enhanced team engagement and productivity through strength-based leadership, managing a cohesive group of professionals dedicated to… Show more Led a multidisciplinary process support team within API production, overseeing SIP, CIP, HVAC, Environmental Monitoring, and Clean and Industrial Utilities. Managed a team of 11 academics and technicians, focusing on continuous improvement, people development, and process optimization.Key achievements:Leadership & Team Management: - Enhanced team engagement and productivity through strength-based leadership, managing a cohesive group of professionals dedicated to high-performance standards.Process Support & Technical Oversight: - Provided critical support across SIP, CIP, HVAC, and utility systems, ensuring compliance and operational efficiency. - Successfully initiated and completed ongoing process monitoring and resolved outstanding PPQ activities on the WFI system.Continuous Improvement & cLEAN: - Led Lean initiatives using A3 and Performance Board tools, resulting in a 60% reduction in team deviations and improving our Performance Board maturity from ad-hoc to consistent.Environmental Optimization: - Reduced energy usage by 10% and water consumption by 13% through targeted improvements in water systems, aligning with sustainability goals.Human Performance: - Drove initiatives to reduce errors and enhance operational safety, implementing best practices that contributed to a safer and more efficient production environment.Stakeholder Management: - Acted as a key liaison between the process support team and other teams and departments, ensuring alignment and smooth communication across the organization Show less

Biopharm Fvii Api Production Ii

I worked as a Validation Responsible and Production Support Specialist within Biopharm FVII API Production, where I played key roles in both project execution and production support over a nearly four-year period. My experience can be divided into two main areas:Project Execution:- Led validation efforts for a protein purification process, successfully managing the transition from SAT (Site Acceptance Testing) to PPQ (Process Performance Qualification).- Conducted… Show more I worked as a Validation Responsible and Production Support Specialist within Biopharm FVII API Production, where I played key roles in both project execution and production support over a nearly four-year period. My experience can be divided into two main areas:Project Execution:- Led validation efforts for a protein purification process, successfully managing the transition from SAT (Site Acceptance Testing) to PPQ (Process Performance Qualification).- Conducted comprehensive validation of CIP (Clean-in-Place) and SIP (Sterilization-in-Place) systems, overseeing the process from OQ (Operational Qualification) to PPQ.- Resolved complex issues and optimized processes in response to validation deviations, ensuring compliance and efficiency.- Collaborated directly with vendors and contractors to oversee the procurement and installation of critical process equipment.Production Support:- Provided daily support to process and production operators, ensuring smooth and efficient operations.- Managed and resolved both minor and major process deviations related to downstream processes, CIP, and SIP, maintaining high standards of quality and productivity.- Spearheaded change control processes for significant changes in downstream operations, CIP, and SIP, minimizing disruption and ensuring regulatory compliance.- Conducted re-validation activities as needed due to ongoing process changes, maintaining the integrity and reliability of production systems. Show less

Aarhus University - Institut For Ingeniørvidenskab - Immunological Engineering

As a intern i worked on functional and structural analysis of therapeutic anti-IgE antibodies in relation to Allergy. My main responsibilties throughout the project was:- Cloning anti-IgE antibodies in different expression systems including, E. coli, Insect cells, and mammalian cell lines - Purifying antibody fragments with different chromatographic methods (affinity, IEX, HIC, SEC)- Quality control of purification method (Chromatography) by SDS-PAGE and Western… Show more As a intern i worked on functional and structural analysis of therapeutic anti-IgE antibodies in relation to Allergy. My main responsibilties throughout the project was:- Cloning anti-IgE antibodies in different expression systems including, E. coli, Insect cells, and mammalian cell lines - Purifying antibody fragments with different chromatographic methods (affinity, IEX, HIC, SEC)- Quality control of purification method (Chromatography) by SDS-PAGE and Western Blot- Crystalization and structural analysis of antibody - antigen complexes- Functional analysis by ELISA, and ELIFAB assays Show less

As a intern during my bachelor i working with characterization, and cellular senescence of endothelial progenitor cells. My main responsibilities was: - Isolation of progenitor cells from umbilical cord blood by magnetic bead conjugated anti-CD34+.- Maintaining and culturing mammalian cell cultures.- Analysis of surface markers on cultured cells by Flow Cytometry - Analysis of cells ability to form vascular tubes over passages - Analysis of cells senescence by beta-gal… Show more As a intern during my bachelor i working with characterization, and cellular senescence of endothelial progenitor cells. My main responsibilities was: - Isolation of progenitor cells from umbilical cord blood by magnetic bead conjugated anti-CD34+.- Maintaining and culturing mammalian cell cultures.- Analysis of surface markers on cultured cells by Flow Cytometry - Analysis of cells ability to form vascular tubes over passages - Analysis of cells senescence by beta-gal assay. Show less

Aalborg

Conscripted soldier in the Royal danish army for 4 month and thereafter 4 months of education in the reaction force as a Medic.

Hd(O)

Graduate Diploma In Business Administration (Hd), 10

Master Of Engineering (M.Eng.), Biotechnology, 10

Bachelor Of Science (B.S.), Biotechnology