Our Team

Education: MSc. in Analytical Chemistry
Background:

• Over 7 years of working experience as analytical chemist in R&D within the pharma industry, including 2 years with inhalation products
• Developed and validated UHPLC methods
• Experience in LC-MS
• Has worked with polymers and small organic molecules

Education: BSc. Innovation Engineering
Background:

• 25 years of experience within product development and plastic components
• Long experience from mobile phones and other similar consumer products
• 12 years working as mechanical design responsible, from concept/early design throughout project execution with requirement setting, evaluating design solutions and design verification
  Experienced in design of precision parts for high volume production

Education: BSc. Innovation Engineering
Background:

• 18 years of experience within product development and mechanical design
• 14 years of experience from mobile and IoT device development
• Experience from DFM/DFA for high volume production and high volume management
• Experience from development of connected health products
• Experience from rapid prototyping techniques and practical work
• Knowledge about design for hygienic requirements

Education: MSc. in Pharmaceutics
Background:

• Over 30 years experience in pharmaceutical development. Mainly in inhalation development
• Experienced in formulation- and device-development of Dry Powder Inhalers both for small and large molecules. Covering work from preclinical phase to commercialisation
• Has worked with wide range of processes including particle size reduction, blending, spray drying and filling
• Experience in clinical manufacturing, equipment and cleaning validation according to GMP

Education: MSc. in Engineering Biotechnology
Background:

• 3 years of working experience as analytical chemist within the pharma industry, including 2 year with inhalation products
• Experience in GC, HPLC, UPLC and device testing
• Good knowledge in GMP for the analytical laboratory

Education: MSc. in Chemistry
Background:

• 2 years of working experience as an analytical chemist within the pharma industry, including 1 year with inhalation products
• Experience in HPLC,UPLC and GC
• Experience in particle characterization
• Good knowledge in GMP for the analytical laboratory

Education: MSc. Mechanical Engineering
Background:

• 7 years of experience in the field of product development, from concept studies to realization and development as well as analysing and testing against technical specifications and requirements
• More than 5 years’ experience of plastic component design of products and mechanisms for office chairs and water system installations
• Knowledge of plastic seal applications and design in elastic polymers
• Knowledge of structural analyses (FEM), 3D printing and model rendering and visualisation

Education: BSc. in Chemical Engineering
Background:

• 11 years of working experience as an analytical chemist, including 2 years in QC laboratory within the pharmaceutical industry and 1 year with inhalation products from AstraZeneca
• Experience in a large range of analytical techniques, e.g. HPLC, UPLC, GC and FTIR
• Experience from working with elastomer based products and tablets containing hormones
• Good knowledge in GMP for the analytical laboratory

Education: MSc. in Chemical Engineering
Background:

• Specialized in electron microscopy and material design
• Experience in method development and design verification of medical devices
• Experience in GC, HPLC, UPLC and device testing

Education: PhD. Organic Chemistry
Background:

• 25 years’ experience of pharmaceutical development, from preclinical phase to registration, including experience with inhalation products and work for small and large pharma companies
• 10 years’ experience as project manager of pharmaceutical, drug-device combination and medical device development projects.
• CMC regulatory affairs responsibility held for drug-device combination products developed for global use from clinical phase 1 to registration. Successful regulatory marketing application approval received for drug-device combination product in EU, US and Australia.

Education: MSc. Chemistry
Background:

• 20 years of experience as analytical scientist, mainly within pharmaceutical development, including 11 years with inhalation projects at AstraZeneca in early phase.
• Experience in physico-chemical and solid state characterization of drug substances and formulations.
• Experience in a large range of analytical techniques e.g. U(H)PLC-UV, LC-MS, XRPD, DSC, TGA, GVS and Laser diffraction.
• Method development and validating analytical methods using HPLC/UPLC in early phase.
• Experience in evaluating polymorphs to make a solid form selection.

Education: MSc in Chemical Engineering. Executive Master of Medical Business Strategy
Background:

• More than 20 years of experience from the life science industry, including 15 years in allergy and asthma.
• Significant experience of global organizations and markets from global positions at companies like Thermo Fisher Scientific, Polypeptide, ALK etc.
• Thorough understanding of the life science value chain through senior roles within relationship management, sales and marketing, GMP manufacturing, R&D and medical scientific affairs.
• Thorough understanding of generic and new drug development.
• Managerial positions in B2B sales, manufacturing and R&D.

Education: MSc and Technology Licentiate in Analytical Chemistry, Lund University
Background:

• +30 years in the life science industry (mainly with inhalation at AstraZeneca) both as a Project Manager and Line Manager for up to 40 people
• Now works for QAdvis AB, an expert MedTech consulting company. In this role, he has recently had assignments as Senior Quality Consultant in Medical Device Companies in both Sweden and Denmark
• Worked with implementation of Quality Systems in a number of smaller companies from basic level up to complete ISO 13485/17025 and GMP requirements

Other assignments
QA Manager at Emmace Consulting AB

Education: Advanced Higher Vocational Education Diploma in Design and Product Development
Background:

• Over 6 years experience within product development and mechanical design: 2 years experience from IoT device development at Sigma Connectivity and 4+ years experience from LED luminaire development at ateljé Lyktan
• Experience in DFM/DFA
• Experience in test and verification of mechanical structures

Education: B.Sc. in Mechanical Engineering specialized in Plastics Technology and Lean Product Development, Technical University Denmark
Background:

• 30+ years of innovative design, development and manufacturing of engineered and physical products for numerous consumers and industries, including Medical
• Broad experience from creating, participating and managing highly efficient R&D projects, from concepts to full scale mass-production, within domestic and international BtB and BtC relations