Expert in Preformulation, Formulation, Innovative Dosage Forms, Up-scaling, Commercial Production, CMC-documentation, Patents and Team Management in Pharmaceutical R&D. GxP Auditor.

Member of the Management Team (2015-2021), Inventor, Director of Pharmaceutical R&D (2015-2021), Head of CMC (2021-2022), and Head of QA (2015-2022).Responsible Person (RP) for EudraVigilance Dec 2018 - Jun 2022.As a member of the Management Team, participating in strategic company decisions and planning of budget for development, manufacturing, and commercial up-scaling. Project Manager of the up-scaling of the manufacturing process at Recipharm AB, Solna and APL, Umeå and Stockholm. Developing and setting the specifications for new product candidates as Project Manager, operative developer, and problem solver. Participating in writing patent documents. Reviewing all quality documentation for the company and its subcontractors and the Quality Management System including the SOPs. Writing the CMC documentation for clinical trial applications and regulatory authority contact documents, reports and IMPD. Appointed as Responsible Person (RP) for EudraVigilance for LIDDS and all their clinical trials, including a multinational prostate cancer clinical trial. Participating as an expert in the Dose Escalation Committee for a multinational solid cancer tumor clinical trial. Main contact to the Swedish Medical Products Agency for the “LIDDS Applikator” medical device for injection. Choosing subcontractors for analytical development and product analyses as well as API sourcing and CRO/subcontractor audits.

Coordinator of the development of Orexo´s new Drug Delivery Technologies. Manager for technology development and innovation teams and responsible for technical evaluation of IP. Leader of finding and exploring external Drug Delivery Technologies and university collaborations.

Director of the Pharm. Development department including 6 employees. Leading the department work, planning, vision, goals, activities, prioritization and budget. Representing the department in project teams and leadership workgroups. Documentation work such as experimental design plans, development reports, SOPs, qualifications, validations, stability studies, INDs, NDAs, Due Diligences, use of controlled substances and statistics as issuer, reviewer or approver internally, externally and to the medical authorities in different countries. Project manager and team leader for in-licensed new projects, Chief designer for 5 different products.

Worked with most of the different existing dosage forms in close collaboration with one of the two part-owners of the company, Henri Hansson. Approximately 50 different projects mainly in Phase I to Phase III throughout the 7 years – of which two thirds were tablet projects and in total > ⅓ were/have led to successfully up-scaled and commercialized products. Project management – both operative and delegating, innovator and problem solver, personnel management, design of experiments, CMC/IND/IMPD-documentation, product filing, up-scaling at CMO sites and supervision of students. Had the opportunity to participate in the naming of a new pharmaceutical dosage form in 2006; portioned snuff pouch (“munhålepulver i portionspåse”). In 2006, the Pharm. Development & Production (production of clinical trial material) department had 9 employees.

Department, project & personnel management as well as pharmaceutical laboratory and document work.

Project management as well as pharmaceutical laboratory and document work.

Trained in the art of tablet and dry/semi-solid dosage form design by Ass. Prof. Nils-Olof Lindberg. Chief Designer for two products.