Simon Schou Email & Phone Number

Bagsværd, Dk

Valby, Copenhagen, Dk

Lundbeck CMC Biologics is a global unit working with global CMOs. We are approximately 100 colleagues, split between Lundbeck Headquarters in Copenhagen and Lundbeck Seattle Biopharmaceuticals. The CMC Biologics organization is built on three strong pillars: I. The Centers of Excellence in Seattle have established laboratories and capabilities within process development, technology transfer, manufacturing, and process characterizationII. The Project & CMO Management is a global function with project leaders based in both Seattle and Copenhagen III. The Manufacturing Science and Biologics Production is located both in Copenhagen and Seattle and consists of three areas: Process Science & Validation, Device Development & Management, and Biologics Production I will head-up Process Science & Validation and together with leaders in Copenhagen and Seattle facilitate collaborations across the entire organization and ensure progress and strategic directions for our CMC Biologics development activities.

Bagsværd, Dk

Project manager for a new strategic initiative, implementing a new platform for production materials with special focus on the environmental impact. The ambition is bold and simple: To have zero environmental impact. To embracing a circular mindset – designing and producing our products so that they can be recovered & reused and reshaping our business practices to minimise consumption and eliminate waste by turning it into new resources.

Bagsværd, Dk

We develop and manufacture oral protein products for late phase clinical trials. We lead the path toward marketing of new oral protein products, expanding NN leadership. We support and optimize processes in OFP facilities in DK and US.

Bagsværd, Dk

Building the organisation from scratch with the goal of launching new oral product to US market. Started as first employee in the user organisation and worked in close collaboration with PM and project team to design and construct the new Oral Launch Plant. This is a standalone facility; including all processes from receipt of raw materials, tablet bulk production, packaging (primary- and 2nd pack) and shipment of finished product, ready for the costumer.Hired the management team and together we build a new organisation; hiring and training +150 employees, working 24/5 with Bulk- and Pack Production. We successfully qualified all equipment, the process was transferred and validated (PPQ) and all audits and inspections were passed. We continuously standardized and optimized our processes and prepared for launch. Launch production was done successfully and ahead of plans, setting a new standard for oral diabetes treatment with a GLP-1 analogue in a pill.Portfolio: Oral Semaglutide (Type 2 diabetes. Phase 3): A long-acting oral GLP-1 analogue intended as a once-daily tablet treatment for people with type 2 diabetes.Product SupplyOFP (Oral Finished Products)

Bagsværd, Dk

Portfolio: Haemostasis, Diabetes, Growth Hormone R&D CMC Supply, CMCAPI Development Biopharm Downstream Development & Virology Development of scalable purification processes. Optimization of each step to give a robust process providing drug substance of required quality (FMC and environmental impact). Project management, patent preparations, submissions for clinical trials and registration files, robot technology and mathematical modelling. Virus/mycoplasma/TSE safety of drugs. Evaluation of animal derived raw materials. QC of mammalian cell banks and unprocessed bulk. Evaluation of clearance of relevant purification processes. Evaluation of cleaning procedures for virus and mycoplama inactivation efficacy.

Bagsværd, Dk

Portfolio: Haemostasis and Insulin.R&DCMC Supply, CMCAPI Development1201 Biopharm Upstream Development Development of cell culture processes in small scale glass tanks, medium scale steel tanks and pilot scale single use bioreactors. The processes include fed batch and continuous cultures (incl. perfusion processes). Support to our pilot plants. Investigating of new technologies and optimizing the technology platform incl. the cell culture media. Production of mammalian cell banks for research, clinical trials and production. Maintanance of our cell banking GMP facility.

Bagsværd, Dk

Portfolio: Haemostasis, Inflammation and Insulin.R&DCMC Supply, CMCAPI Development1201 Biopharm Upstream Development and 3631 CMC Stem Cell Development1201: Development of cell culture processes in small scale glass tanks, medium scale steel tanks and pilot scale single use bioreactors. The processes include fed batch and continuous cultures (incl. perfusion processes). Support to our pilot plants. Investigating of new technologies and optimizing the technology platform incl. the cell culture media.Production of mammalian cell banks for research, clinical trials and production. Maintanance of our cell banking GMP facility.3631: Leading innovation within the area of bioprocess development with focuses on the translation of stem cell research into clinical application. Our objective is to develop cell replacement therapy into a viable option for treating Diabetes Mellitus, by developing procedures for pilot scale cultivation and purification of beta cells derived from stem cells.

Bagsværd, Dk

Portfolio: Haemostasis, Inflammation, Growth HormoneR&DCMC Supply, CMCAPI DevelopmentBiopharm Downstream Development & VirologyDevelopment of scalable purification processes. Optimization of each step to give a robust process providing drug substance of required quality (FMC and environmental impact). Project management, patent preparations, submissions for clinical trials and registration files, robot technology and mathematical modelling. Virus/mycoplasma/TSE safety of drugs. Evaluation of animal derived raw materials. Testing of mammalian cell banks and unprocessed bulk. Evaluation of clearance of relevant purification processes. Evaluation of cleaning procedures for virus and mycoplama inactivation efficacy

Bagsværd, Dk

Portfolio: N9-GP, a long-acting recombinant coagulation factor IX derivative intended to offer prophylaxis and treatment of bleeds.Product Supply, Biopharmaceuticals, Biopharm API management Production of N9-GP for phase 3 clinical trials and preparations for marked production

Bagsværd, Dk

Portfolio: Haemostasis and Inflammation.R&D, CMC Supply, CMCAPI Production.Cell Culture Pilot Plant (4 teams, +60 persons)Development and up-scaling of processes within mammalian cell culture and recovery. Manufacture of API for investigation, pre-clinical and clinical phases I-III. Transfer of API processes and knowledge to Product Supply. Documentation of the API process development from research to launch (incl. regulatory filing). Designing, validating and maintaining our facilities according to cGMP, ISO 14001 og ISO 9001

Bagsværd, Dk

Development and upscaling of cell culture processes for new biopharmaceutical proteins for clinical trials. Clarification of harvest. Developing and improving a standardized technology platform for monoclonal antibody production. Maintaining a laboratory and pilot plant facility according to cGMP.

Bagsværd, Dk

Team leader for the fermentation and cell banking team. Principle scientist: Preparation, characterization and storage of microbial cell banks in a dedicated and classified facility according to cGMP. Development of fermentation processes in laboratory- and pilot plant scale (including clarification processes).

Bagsværd, Dk

Qualification of equipment, cleaning validation, proces validation of production processes for multiple hormone solid dosage form products. Planning and completion of FDA inspection (Vagifem).

Responsible for production of granulates for solid dosage form (incl. management of two shifts).

Msc Chem. Eng. / Lean Black Belt / E*Dip. Mmpi

Msc, Chem. Eng. _ Microbiology

Education record