Dr. Stephan Maier

* Responsible for the overall operational business of the newly established BU Pharma & Biotech covering leadership of the departments Production, Supply Chain Management, Engineering, R&D, Project Management, Quality Control, Quality Assurance * Managing a growing team of currently 50 members of which all leading personnel of above mentioned departments are direct reports * Project lead of several extension projects

* Greenfield development of a new pharmaceutical Business Unit including establishment of production and QC premises and equipment, development of the pharmaceutical QMS, development and structuring of the organization * Successful obtainment of the manufacturing authorization for Human Medicinal Products for the site * Development and leadership of the BU covering the functional areas Pharmaceutical Production, QC, QA, Product Development and Engineering; personnel responsibility for a team of 40 members

Steering of all manufacturing and logistics activities of tesa Labtec GmbH at Hamburg plant. Compliance of all operational activities with current legal requirements for the manufacture, storage, and distribution of medicinal products (EU and US Guidelines) and medical products. Fullfilment of legally required duties and functions as 'Head of Production' according to AMWHV and EU GMP Guideline. Member of Board of Management.

Responsible for all transfer and contract manufacturing projects of the company from scale up / transfer to market launch. Managing the functional areas of project management, product and technology transfer, scale up and process development, regulatory affairs and stability analytics. Responsible for strategy development, portfolio management, project controlling. Qualified Person acc. to §14 German Drug Law. Member of Board of Management.

Multidisciplinary management (project lead) of several international development projects. Supervision of formulation development team, design of manufacturing processes. Responsible for planning and evaluation of process validation, stability programs, coordination of clinical studies, and writing of CMC sections for registration dossiers. Scale up and tech transfer of products from R&D to commercial production, support of product launches.

Customer oriented management of international development projects. Formulation development of oral, topical, and transdermal delivery systems. Improvement and maintenance of the quality system; conducted quality audits and employee training.