Dirk Lange

Globally responsible for Novartis Biologics Third Party Operations (External Supply Operations & outsourcing). Development collaborations, clinical and commercial supply of Drug Substance and Drug Product across all divisions of Novartis.

Executive with over 16 years of experience in Biopharmaceutical Development and Manufacturing. Prior to joining Sandoz, Dirk held leadership positions in Operations, Project Management and Business Development at KBI Biopharma (USA) and Rentschler Biotechnologie (Germany). Dirk has directed the manufacturing of well over 1,000 clinical and commercial Drug Product and Drug Substance manufacturing campaigns. He has been involved in numerous inspections with the FDA, EMA and other health authorities.

As Vice President, Manufacturing Operations I am responsible for cGMP Manufacturing at KBI Biopharma. Our capabilities include Microbial Fermentation and Mammalian Cell Culture up to 2,000L. Further responsibilities include Procurement, Logistics, GMP Warehousing, Facilities & Engineering as well as Program Management.

As VP, Global Strategic Alliances I am in charge of Business Development (Sales and Marketing) as well as Program Management. KBI Biopharma is a leading biopharmaceutical contract development and manufacturing organization offering cell line development, upstream and downstream process development, cGMP manufacturing (microbial and mammalian expression systems in stainless steel and disposable bioreactors up to 2,000 L), formulation development and extensive biophysical and biochemical characterization.

As VP Drug Product Manufacturing I work for the US based CMO KBI Biopharma. My responsibility is to build up and run a fill&finish facility and a team to expand KBI`s service portfolio. We will be offering formulation, liquid filling and lyophilization as well as labeling and packaging for clinical trials and initial commercial supply of parenteral products.

International acquisition of develeopment and production projects, project management: Process and method transfer

Managing a team responsible for implementation of new products. Process and QC method transfer

Managing a Drug Product formulation team, responsible for process transfer

Formulation, aseptic filling, lyophilisation, GMP documentation