Uppsala, Uppsala County, Sweden
Experienced Senior Project Manager with demonstrated history of working in both the Medical Device and Pharmaceuticals industry. Has spent the last 5 years within Medical Devices and developed a holistic understanding of MD-regulations including expertise in Design Control and Risk Management according to ISO14971. Skilled in U.S. Food and Drug Administration (FDA), QA, Analytical Chemistry, Technology Transfer, MES, Data integrity, Product chemistry, Packaging including extractables and leachables, Design Control, Risk management according to ISO 14971 , Validation, and GMP. Strong program and project management professional with a Master of Science focused in Chemistry from Uppsala university.
Responsible for developing the drug substance together with a CRO. Co- inventor of 2 drug substance patents.
Project manager for implementing MES (Manufacturing Execution System) in the production. MES includes IT, computer validation, data integrity, digitalization, business processes, change management. Senior Project Manager within the Business Unit Parenteral Nutrition, Colloids & Ketosteril. Developing new global pharmaceutical products including clinical trials, developing new API:s, stability batches, CMC-package. International contacts.
* Chemical specialist on intravenous lipid emulsions and intravenous amino acid solutions. * Chemical specialist on extractables and leachables from packaging materials for parenteral nutrition solutions. * Setting up advanced education material in product/chemical knowledge and educating within Fresenius Kabi world wide. * Leading task force teams during urgent situations within the production
Responsible for the design of the parenteral nutrition solutions (PN emulsions, amino acids and vitamins) produced world wide within Fresenius Kabi. International contact and coordination.
Coordinating finished product projects from costumers as third party manufacturing. Tech transfer projects.