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.
• 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.

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.

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.

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.

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.

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.