GENAU & MORE - Key Persons
Job Titles:
- Manager & Senior Consultant / Quality Control / Quality Management
B. Eng. in Electronics from Aarhus University with more than 5 years of experience as an automation engineer and consultant in the pharmaceutical industry.
In the role as lead automation engineer and consultant I have built solid competencies founded in IT & Automation system design from initial project design phases, all the way through to commissioning and qualification of the specified system. Taking part in both planning, design, documentation and integration of automation systems.
Camilla holds a Master's degree in Animal Science from the University of Copenhagen.
She has more than 9 years of experience with pharmaceutical production, where Camilla has been involved in both the daily production and project work.
Camilla has worked as a Chemist at Novo Nordisk and as a Senior Professional for Novo Nordisk Pharmatech. For both positions, the main focus was to keep the productions running, ensure product quality and patient safety, as well as support the environment and financial sustainability.
She has extensive experience with deviation processing, change cases, validations and is specialized in LEAN, systematic problem solving and optimization projects. Camilla has a strong quality mindset and in-depth experience with GMP and compliance with internal and external requirements. In addition, Camilla is used to having a central role in acute issues arising in the productions.
Job Titles:
- Senior Consultant
- Manager & Senior Consultant / Quality Assurance
Charlotte holds a master's degree in Pharmacy from The University of Copenhagen. She has more than 12 years of experience with quality control, quality assurance and design control within the pharma and medical device area.
Previously, Charlotte worked 8 years in the Medicines Control Division in the Danish Medicines Agency gaining a keen eye for critical review of documentation and obtaining extensive knowledge of the regulatory framework for the pharmaceutical industry. She has also worked with class III medical device implants as a Quality Engineer supporting the CAPA - and Change Control Process with her strong quality mindset. Latest, she has worked as a Senior Consultant, primarily supporting small enterprises in developing the technical documentation for their medical devices in accordance with the Medical Device Regulation.
Christian Ilsøe, formerly Novo Nordisk, NNE A/S and Dansk Standard. Most recently, Christian has been a partner, co-owner and member of the Executive Board at AlfaNordic A/S.
Christian is a graduate (M.Sc., Dairy Science) from the Royal Veterinary and Agricultural University in Denmark with relevant further career education, including a MPO in Organizational Psychology from Roskilde University. Christian's primary experience and expertise includes Quality & Compliance, development of organizations, business models and management.
Dr. Efstathios Vassiliadis are hired as Director and Senior Consultant
Job Titles:
- Chairman of the Board
- Member of the Chairman of the Board
Ellen Trane Nørby, former Minister of Health and Minister of Children, Education and Gender Equality. Ellen is Cand. Mag. in Art History from University of Copenhagen, with a minor in Social Sciences, and has throughout her career held several positions of trust and been (co-author) on several publications.
Job Titles:
- Consultant
- Member of the Risk Management Committee
By working hand-on with these systems and equipment, he has written rationales for risk assessments of alarm lists and parameter lists and combined these lists with automatic collection of audit trail and alarm logs. He has tested the systems from line actions, to storing data on servers and finally by verifying whether correct data is available in batch journals for product releases.
As a consultant, Frederik has a logical mindset which helps him with problem solving in an efficient and high quality way.
Frederik Winther Vahlgren is a consultant with a background as a mechanical engineer. During his education and more than four years of experience he has gained a solid knowledge of machines including assembly-, labeling- and packaging machines. Frederik has also worked on several projects with implementation of electronic data integrity systems.
Helle Petersen is hired as Director, HR & Communication
Job Titles:
- CEO
- Senior Consultant
- Senior Consultant and Specialist in Good Manufacturing Practice
Henrik Johanning is a senior consultant and specialist in Good Manufacturing Practice (GMP), IT & Automation as well as testing, qualification and validation documentation. Furthermore, Henrik has extensive experience with equipment, constructions and processes.
Henrik has over 20 years' experience with complex IT technical tasks from the pharmaceutical industry and others. Previous clients include manufacturers of medicine and medical equipment. Within medicine, Henrik is particularly experienced with fermentation, purification, cell cultures and vaccines.
Henrik works with both strategy and implementation, so he is particularly qualified to manage projects within areas like quality strategies and inspection readiness, as well as to prepare documentation and to perform and report testing, qualification and validation.
All in all, Henrik has acquired in-depth knowledge within broad aspects of business-related and quality-related challenges and solutions.
Henrik Johanning joins the European editorial board of Pharmaceutical Technology Europe
Ida holds a civil engineer in pharmaceutical technology from the Technical University of Denmark and she has a great interest in drug development - from the early research stage into new drugs, until the drug reaches the market and ultimately where it makes a difference for patients.
She has experience in understanding the processes involved in the development, manufacture, production, market release and regulation of pharmaceuticals. Ida has worked with regulatory data management and therefore has experience with regulatory processes and handling regulatory GxP data.
Furthermore Ida has worked in several project offices and has plenty of experience with project and program management as well as stakeholder management within both R&D and IT projects. As part of Agile Release Trains, she has worked with driving organizational changes from traditional to agile project management, which has equipped her with a forward-looking and iterative approach to project management and process optimization.
Job Titles:
- Member of the Risk Management Committee
- Senior Consultant / Design Control
Jesper Brandt Rasmussen holds as M.Sc. in Chemical Engineering from the Technical University of Denmark.
Jesper has more than 10 years of experience from the Life Science industry as both a consultant and an employee. He has built up solid competencies within the development of medical devices, as well as the preparation of quality documentation within the pharmaceutical and MedTech industry. This applies in particular to Design Control deliveries, testing and verification activities, requirement specifications and validation documentation.
Johan works as a CFO and has a background as Cand. Merc., Finansiering & Regnskab, Copenhagen Business School. Johan has worked in Denmark, Sweeden and UK as a consultant with finance, strategy, and M&A for 6 years. Herafter 9 years with similar work within companies as Wood Wood, Sportmaster and GreenEnergy (UK).
Johan is besides his responsibilities at Genau & More engaged in consultancy and board services. Johan's focus is financial and liquidity management and contribution to the strategic development of Genau & More A/S.
Jonas is educated at Roskilde University with a BA in Business Administration & Economics. His heart beats for the Medtech and Life science industry, a passion deeply rooted in his own experiences as a patient living with CCHS (Central Congenital Hypoventilation Syndrome).
Jonas' professional history is remarkable, with an impressive range of internships and student assistant jobs in startups within the IT industry, including renowned companies like Talenthub/Starred and Statum, known from the popular TV series "Løvens hule" (Also known as Shark Tank). He has actively participated and worked in various business areas, including Product Development, Sales, Customer Success Management, and a wide range of Operations functions.
His belief in the "patient for patients" principle forms the heart of his professional approach, and his natural energy, positivity, and sharp analytical skills have made him a desired collaborator in any context. Jonas has a special ability to thrive in collaboration with others and is known for creating an atmosphere of productivity and cohesion in all projects he is involved in.
Jørgen Damsbo Andersen has held management positions in Novo Nordisk, Orion Pharma, Celltech / UCB and ALK Abello. Most recently, he was Executive Vice President (EVP) and a member of the Executive Board of LEO Pharma.
Jørgen has a Cand. Merc. from Copenhagen Business School (CBS) with futher subsequent educations. Jørgen's primary experience and expertise includes commercialization, innovation (business models), optimization and global management.
Karina Jørgensen is hired as Consultant within Business Development
Job Titles:
- Appointed Junior Consultant
- Consultant & Project Manager / Design Control / Risk Management
Lars holds a degree in Health Technology from Aarhus University and a Master's in Industrial Economics and Management from the Technical University of Denmark. Lars has a great passion for the Life Science industry, where he wants to make a difference for users/companies and patients.
Lars has been employed at G&M for more than 6 years and has gained extensive experience and expertise with project management in pharma and medical technology. Of which the combination of regulatory expertise is applicable to coordinate and execute projects ensuring proper compliance, timely deliveries and cost estimates. This is supported by his great theoretical knowledge from studies and further training in LEAN management, project management, process optimization, operations analysis, business development, business analysis, biomechanics, communication, programming and design of graphical user interfaces for medical use, construction of hardware, patient safety, CE marking, risk analysis , medical information systems, QMS and classification of medical devices.
Job Titles:
- Senior Consultant / Quality Management
Lene has a MSc. in Food Science and Technology and has more than 17 years of experience from various business areas. She has worked with product development of ingredients for the food industry and has recently acquired extensive experience in qualifying and implementing equipment/facilities used in the production of medical devices. Development, validation, implementation and monitoring of cleaning processes in a regulated production environment have been a significant part of her tasks. In addition, she has experience with change cases, deviations, risk assessments, external and internal audits.
From her previous positions as Manufacturing Engineer and Research Scientist, Lene has experience in creating an overview of complex processes and knows how collaboration with a wide range of professional groups can create positive synergies. Lene has given a good understanding of production processes by working in various production companies with both product development and production support.
Lene has a structured, analytical and solution-oriented approach to tasks and a committed focus on getting to in depth of the task. She works with a dedicated focus on quality and patient safety.
Job Titles:
- Consultant / Design Control
Job Titles:
- Consultants
- Senior Consultant & Quality Responsible
Michael is a consultant within GMP IT and Automation as well as medical equipment. Michael is a graduate engineer in Health Technology from AAU, and he subsequently worked as a researcher in basic pain mechanisms at the Center for Sensory-Motor Interaction (SMI), which involved designing and performing experimental humane pain studies.
Michael has quickly gained experience within a number of areas in the pharmaceutical industry. These included packing lines, formulation, filling and serialisation of packing materials, domestically and abroad. The tasks involved the preparation of most validation documents, from FAT/SAT to final reports such as XQR/VPR, as well as participation in the performance of tests and qualifications. Currently, Michael's work includes project coordination and management of projects involving migration of process equipment and procurement of equipment for purification processes.
Michael's experience with cooperation within the pharma industry is thus professionally and geographically broad. He therefore has a particularly solid grasp of work processes and validation procedures. Michael continues to gain experience with the creation, management and performance of change cases, and alongside his consultancy work, he is attending a course to become a PEM-certified project manager.
Job Titles:
- Member of the Auditing Committee
- Manager & Senior Consultant / Quality Control
- Specialist, Project Manager and Manager at Novo Nordisk
Morten holds a bachelor's degree in chemistry from Aarhus University, and a subsequent master and Ph.D. in molecular biology. He has more than 11 years of experience with quality assurance, management, and project management.
Morten has worked as a specialist, project manager and manager at Novo Nordisk, Novozymes, and Fertin Pharma, and has therefore both hands-on and management experience with upholding the right quality level in relation to current regulatory requirements. He is used to working with processes, procedures, and batch records in a practical approach in relation to process and production support. He also has experience with deviations, CAPA, change controls, and project management, and is used to presenting documentation at audits and inspections.
Job Titles:
- Senior Consultant / Quality Control
Nikolaos is educated as an Automation Technician from the Danish Armed Forces and spend over 15 years in the Danish Armed Forces. There he worked as an automation technician, weapons technician, and electrician.
He has more than 4 years of experience with Quality and Compliance in the pharmaceutical industry lately at Bavarian Nordic and at Novo Nordisk (DFP Hillerød).
Nikolaos has a lot of experience working as an Automation Specialist with technical insight in automation systems used in all the different phases of pharmaceutical production. He has also worked as an automation subject matter expert in various projects across all areas of pharmaceutical production. In this function, he has collaborated with project managers and system owners in the specification, documentation, and configuration management of new systems.
Nikolaos has been responsible for coordinating tasks with IT specialists, associated consultants and equipment suppliers. He has experience with ensuring data integrity and validity of systems and has been responsible for presenting and defending automation solutions and IT systems for inspections and audits.
Job Titles:
- Communikation & Office Manager
Pernille works as a our Communications & Office manager and has a Master in Design Management from the University of Southern Denmark and the Design School in Kolding. She has a lot of experience in PR, communication, digital marketing, sales, websites and business development from both sports clubs and consulting companies. Pernille is Genau & More's "communication-octopus" and GO-TO'er, who ensures that the daily "office-life" runs smoothly for our entire team and partners.
Peter is a board member and was previously CFO (Chief Financial Officer) at Genau & More for 7 years. Peter is a certified public accountant and, until mid-2012, was a partner at EY (Ernst & Young). Furthermore, Peter is a chairman of the board / board member in several small and medium size companies, and he also acts as a financial adviser in different contexts.
Johan Gertz joins as new CFO. Former CFO Peter Hertz continues as a member of the Board of Directors
Job Titles:
- Senior Consultant / Quality Control
Rasmus holds a Master of Science in Process technology from Aarhus University. He has 11 years of experience within the pharmaceutical industry from Novo Nordisk, and thus has extensive experience within GMP, compliance, quality assurance and validation of processes for medicinal products. Including process validation, qualification of process and process equipment, deviation management, as well as carrying out and documenting change requests on a larger and smaller scale.
Most recently, he has been lead for the quality assurance in implementing of new products and equpment in the Recovery facility AE at Novo Nordisk in Kalundborg. For many years he has been product manager for various products in a close cooperation with the development department as well as Regulatory affairs and therefore has been at the forefront of implementing major changes to the processes, as well as building the process for a new product. Rasmus has participated in many audits and inspections, as presenter for various countries from the USA (FDA), DKMA (the Danish Medicines Agency) to South Korea, Russia and Turkey.
Job Titles:
- Senior Consultant / Quality Management
Rikke holds a master's degree in Food Science & Technology. She has more than 16 years of experience from a variety of business areas with main focus on quality management. She has been responsible for developing and implementing both ISO 9001 and ISO 13485 quality management systems and has experience with both third-party audits, customer audits, supplier audits, and internal audits.
From her former role as quality manager, Rikke has experience with getting the overview of complex processes and knows how working with a wide array of different professional groups can create positive synergies. She has experience with process optimisation and problem resolution using lean six sigma tools, as well as hands-on experience with handling change requests, deviations, and customer complaints. Working in various production companies has given Rikke a good understanding of production processes.
Rikke has a structured, analytical, and solution-oriented work approach and is always curious to get to the core of a task. She works with a profound focus on quality and patient safety.
Job Titles:
- Senior Consultant / Quality Control
Rune holds a MSc. in Biology from Aarhus University and has more than 10 years of experience with Quality and Compliance within the pharmaceutical industry.
From his previous positions as Senior Process Specialist and Chemist, Rune has experience with Continued Process Verification, implementation of continuous improvements in production as well as statistical analysis work in connection with processing OOS and OOE analysis results, root-cause analyzes and implementation of CAPAs and amendment cases. Furthermore, he has been responsible for the implementation and reporting of chemical and microbiological monitoring programs.
Rune has extensive experience with case processing, handling incidents in production, systematic problem solving, carrying out deviation investigations and reporting them, interpreting data and preparing change cases.
Rune works structured with a focus on finding the best possible, data-based solution for a given task. Patient safety, quality and compliance with regulatory requirements are always in focus.
Sidsel has a degree in Healthcare Technology from Aarhus University, Department of Electrical and Computer Engineering. During her studies,
Sidsel has acquired knowledge to understand processes in the development of medical devices, QMS, usability, UX design, organizational understanding, implementation and project management. She has worked with safety and quality aspects in the development of systems and equipment to ensure compliance with the Medical Device Regulation (MDR), as well as worked with user-centered design processes in the development of interfaces to ensure usability.
As a consultant, Sidsel is detail-oriented and works systematically to plan and understand problems, barriers, workflows, processes, and projects, but her most important tool is the compassionate understanding and interaction with customers exactly where they are.
Job Titles:
- COO
- Partner
- Senior Consultant
Simon holds a MSc in Eletrical Enginering - Automation and Robot Technology. Subsequently, Simon has accumulated more than 10 years of experience in the pharmaceutical and medical device industry at e.g. Novo Nordisk and NNE, where he has developed into an experienced project manager with broad competences within Embedded Software, GMP, IT & Automation as well as Computer System Validation.
As a person, Simon is both structured and analytical, and he goes to the daily tasks efficiently in a creative and solution-oriented manner. Simon is an enthusiastic, positive and welcoming colleague. This also makes him an empathic communicator with a natural sense and respect for human relations and cooperation.
Simon Bagger is appointed as COO (vice president) and partner
Simon Bagger is hired as Consultant and Manager, IT & Automation
Theis holds a B.Sc. in Healthcare Technology from the Technical University of Denmark and has experience within medical technology in the public health sector.
During his studies, Theis has gained knowledge to understand processes in developing medical devices, QMS, project management and is able to connect the two worlds of technology and healthcare. He has worked with safety and quality aspects in the implementation of medical devices to assure compliance with the medical device regulation, as well as working with user-centred design processes.
As a consultant Theis is detail oriented and works systematically for planning and finding solutions for problems, workflows, processes, and projects, but his most important tool is the human understanding and meeting clients exactly where they are.
Job Titles:
- Consultant for Epista Life Science
- Quality Control
Theresa holds a master's degree in Biology-Biotechnology from the University of Copenhagen from 2021. An international and research-oriented master's degree with a focus on identifying and solving biological problems. She has broad experience with laboratory work, biotechnological innovation, advanced bacteriology as well as microbiology and immunology.
Theresa has strong skills in bioinformatics, big data analysis, experimental design and a wide range of molecular biology techniques.
Previously, Theresa has worked as a consultant for Epista Life Science where she helped develop quality documentation for validation projects and updated Standard Operating Procedures. She has also worked at Xellia Pharmaceuticals as a QA assistant in the Manufacturing Quality Assurance department. Here she worked with environmental monitoring, trend analysis, GMP video review of process simulations and participated in the annual GMP training.
Job Titles:
- Senior Consultant
- Senior Consultant / Design Control
Vibeke Bach-Hansen holds an AP Degree in Chemical and Biotechnical Science from Zealand - Academy of Technologies and Business. She has more than 10 years of experience and has throughout her career worked with quality control and quality assurance within analytical laboratories and Design Control within medical devices.
Previously, Vibeke worked as the Quality Responsible in an ISO 17025 accredited laboratory and as a QA Engineer in an ISO 13485 certified company where maintenance and raising awareness of the quality system was the primary task. She is sharp within ISO 13485 and internal auditing in precisely this standard.
Vibeke was also responsible for the Change Control process and supported the NC / CAPA processes with her positive and solution-oriented approach to the workflows.
She has also worked as a Design Control Specialist with class IIb medical devices where management and preparation of design control/technical documentation were the focus area. As a Design Control Specialist Vibeke has achieved extensive knowledge of the different development stages as well as the regulatory requirements that apply to the development of medical devices.
"I am a positive and pragmatic person who enjoys a structured everyday life but can also easily adapt to ad hoc tasks. I have what it takes to ensure progress in my tasks, and I take great pride in delivering on time, while maintaining a high-quality level. I believe that we will find a solution together and can have a constructive dialogue about the path to the common goal. I challenge processes and am curious about why we do as we do - and whether it is still the most optimal way to do it"