Hamburg, Hamburg, Germany
Pharmaceutical industry can be such a small world, especially in the field of oncology. Meeting many distinguished ladies and gentlemen in this industry has been my pleasure and privilege over the last 26 years, and I look forward to the next such meetings. Let us meet and create! Currently as the registered head of production (AMWHV 13), I am in charge of all matters related to the production of human medicinal products (mainly oncology medicines) manufactured according to EU GMP guideline that are sold mainly in Germany/EU and also in the rest of the world. I am also the head for the business unit GMP consulting within AqVida.
Registered Head of Production for Hamburg Authority (AMWHV 13). Involved in many details related to the development of the product, process optimization, process transfer, production, packaging, as well as (but most importantly) GMP operation. Perform customer audits of the suppliers and manufacturers for API, FDF, and primary packaging materials. Designed, engineered, and built a new manufacturing site and robotic isolator-filling machine for sterile oncology injection in Germany.
Provides consultation for EU GMP and US cGMP operations and related business development strategy. So far, I have been involved in various projects: GMP gap analysis (GMP audit), GMP upgrade and training for authority inspection, CMC documents review for US and US clinical trial/marketing authorization, US FDA pre-IND meeting, technical transfer and clinical trial production at US and EU contract manufacturers, facility design, equipment/system engineering, etc.
New generic product development. Involved in API selection, process development, process validation, dossier compilation, and marketing. Involved in the designs of new production sites (sterile injection filling) in conceptual, basic, and detail design phases.
Planned marketing strategies designed for new projects and new products. Strategy Design involved communications that are internal (R&D, Manufacturing, Sales) as well as external (registration partners, customers, consumers such as doctors, pharmacists, and clinicians).
New generic product development. Involved in API selection, process development, process validation, dossier compilation, and marketing. Involved in the designs of new production sites (sterile injection filling) in conceptual, basic, and detail design phases.