Malin Gidlund Email & Phone Number

Uppsala, Se

Uppsala, Uppsala Län, Sverige

Uppsala/ Stockholm

Short-time assignments in pharmaceutical development and technical operations.

Uppsala, Uppsala County, Sweden

Site manager at Uppsala Site, leading Laboratory Operations including 3 functions (Production, Customer service & Lab Support and Technique & Methods) (3 managers (totally 15 employees in 2023)). Member of the Corporate management team of A3P Biomedical and led the Laboratory Operations management team.Examples of main responsibilities and achievements:Healthcare provider, Responsible to provide analysis services from the clinical laboratory (In-Vitro Diagnostic (IVD)) to national and international customers and manage and maintain “Test delivery process of Stockholm3 (a clinically and commercially validated blood test for early detection of aggressive prostate cancer)”. Managed development of the organization; staff, facility, systems and suppliers, met requested capacity and turnaround time, managed process development, internal and external production of company products (control samples) in the clinical laboratory and company biobanks. Establishment at new site and implementation of working procedures to fulfill ISO 15189.Jan 2021-Aug 2021 • A23 Lab AB • Covid-19 projectExamples of main responsibilities and achievements:Healthcare provider, Responsible to provide analysis services from the clinical laboratory (In-Vitro Diagnostic (IVD)) to customers and manage and maintain “Test delivery process of Covid-19 test”. Decommissioning of Covid project during March-Aug 2021.

Uppsala, Sverige

Line manager, 8 employees and 9 consultants (senior scientist, product developer, chief designer, CMC/IND/IMPD doc manager, process engineer, quality engineer, production manager, technical operator). Object owner of the laboratory premises, systems, utilities and equipment/instruments within the function domain (Research and cGMP facility). Member of the R&D management team of Orexo AB. Representing the department in project teams and leadership workgroups.Examples of main responsibilities and achievements:Led the function to develop new proprietary drug delivery technologies and new products to be commercialized based on Orexo’s proprietary drug delivery technologies. Responsible for product- , process- and packaging development. Upgraded the quality system of the working procedure for manufacturing of technical trials and clinical trial material in the same facility and equipment.Performed couple of investments in the facility (upgraded EMS and installed a filling machine and spray dried equipment for intra-nasal products based on amorphOXTM platform).

Uppsala, Sweden

Line manager, 10 employees (project managers, process engineers, process and cleaning validation leaders) of a function responsible to improve and maintain the commercial manufacturing processes (incl. raw and packaging material, API manufacturing, tablet manufacturing and packaging of finished product). Member of the Technical Engineering management team of Recipharm Uppsala AB and the Site team for daily supply to existing customers. Representing the department in project teams and leadership workgroups.Examples of main responsibilities and achievements:Led the function to support ongoing Investment projects for success (new automation system for API manufacturing, improve the process of tablet manufacturing, change the primary pack of the final product, install serialization packaging line) and the daily supply to existing customer. Achieved an optimized use of resources in various forums, a more effective communication in the projects, teamwork and clearer individual responsibility.

Uppsala, Sverige

Member of the R&D and Operations management team of Orexo AB. Participated in GMT meetings (Global Management Team).Led early development projects in pre-clinical and phase I in collaboration with contract research and development organization, CRO in Europe and Asia.Led three (3) line extension products based on Orexo’s developed sublingual tablet Zubsolv® registered in US in pharmaceutical development and establishment of commercial manufacturing sourcing at external contract manufacturer in US. Led outsourcing of manufacturing and packaging of Diabact® UBT tablet on behalf of Kibion AB to a new contract manufacturer in Europe.The projects included selection of suppliers, negotiation of contracts, regulatory documentation, formulation, analytical and clinical development, manufacturing, packaging and supply to approved market. All goals were successfully achieved.Led strategy business projects. Established and implemented new business working procedures; Pharmaceutical Product Development, Establish New Supply To Customer and Corporate Risk Management. Interacted with Swedish Medical Products Agency at inspection.

Uppsala, Sweden

Line manager (interim), 9 employees and member of the R&D and Operations management team of Orexo AB. Object owner of the laboratory premises, systems, utilities and equipment/instruments within the function domain. Representing the department in project teams and leadership workgroups.

Uppsala, Sweden

Led the establishment of commercial manufacturing sourcing of Orexo´s developed sublingual tablet Abstral® for both Europe and Japan market at a new external contract manufacturer. Led the establishment of the commercial manufacturing sourcing of the active pharmaceutical ingredients in Orexo´s developed sublingual tablet Zubsolv® during development and launch phase at a new external contract manufacturer in Europe and US.The projects included selection of suppliers, negotiation of contracts, regulatory documentation, formulation and analytical development, manufacturing, packaging and supply to approved market. All goals were successfully achieved.Acting as co-auditor for Orexo at audits of potential API suppliers. Interacted with FDA at approval of Orexo´s product Zubsolv®.

Sodertalje, Sweden

Led NPI projects at the receiving part. Transfer manufacturing process from R&D to commercial manufacturing site. Scaling -up and manufacturing of clinical trial material. Working in close co-operation with R&D and Operations staff.Led Business management project; change management, process improvements, Lean.

Sodertalje, Sweden

Supported commercial production of drug substances: trouble shooting and trending, coordinate the implementation of changes, writing batch records and standard working procedures, training technical personnel, LEAN techniques, e.g. visual planning. cGMP. Plus acting as a Leader of a process team.

Sodertalje, Sweden

Chief designer, scaling-up, process improvements, troubleshooting, process qualification and validation. Contributed writing Drug Substance part pf CMC documentation for New Drug Applications. cGMP

Sodertalje, Sweden

Design and develop manufacturing processes of new drug substances. Laboratory- and pilot scale. Coordinated and led the development work as a Responsible development chemist. External and internal collaboration. Worked 5 months at Charnwood site, UK. Contributed to write Drug Substance part of CMC documentation for Clinical trial applications and New Drug Applications