Hamit Akbay

• Project Management of the CMC (Chemistry, Manufacturing and Controls) activities in R&D reflecting the overall CMC strategy • Member of the integrated CMC project team • Preparation and execution of CMC project plans from early phase clinical development up to submission and approval including progress follow up • responsible for monitoring the project progress and for providing proactive optimization of cross-functional operational activities

• Leading the project portfolio and product life cycle management • Site Leadership Team member • Contribution to budget and long-range plan • Steering meetings with external customers for CMO business • Ensure the sustainability of product business in close cooperation with commercial operations and industrial strategy group • Interface for CDMO/CMO requests and business evaluation • Continuous improvement program for the project management performance and performance plans for the top 5 products on site

• Industrialization projects (internal and CMO) to implement new manufacturing processes for key active pharmaceutical ingredients on site with a contribution of 40% of the total site activity • Ensured the tech transfer from Development to the Industrialization team • Responsible for project planning and budget • Executed the project strategy defined in the project charter • Key contact for external stakeholders • Coordinated the relevant departments for the working packages

Performing Six Sigma Black Belt Projects for the Lubricants department and Wiesbaden site (Project Management). Implementation of strategic second sourcing for the Lubricants department. As Part Time Business Evaluator providing support for commercialization excellence projects, preparation and reviewing financial scenarios (economic profit, rona) to determine the probability of value creation.

Geo expansion department, planning and designing a six sigma lean manufacturing site including multi generation site master and project plan on a green field site. Controlling budget, hiring people, decision maker concerning process and design of the plant, leading the multicultural project team consisting of 40 people from 5 different countries.

Production Team Leader with 25 direct reports. Full budget and cost responsibility and people management. As Project Leader moved the whole production team including its assets from the existing building to a new one applying six sigma lean manufacturing principles and generating a multi generation project plan for this unit.

Within ISO 9001 and TS 16949 criteria combination of a Quality and Manufacturing Engineer responsible for construction sealants, electronics gels and some rubber materials. Performed several six sigma process improvement and cost reduction projects. Received an award for one of the best 10 six sigma lean manufacturing projects. As Quality Lab Leader 6 direct reports, renewed the department, reorganized the team, implemented sample manager to increase the automation level.

Chemical engineer in the EHSS department creating the diffuse emissions report to the environmental ministry (TA Luft).

Chemical engineer in the research and development department for paints.

Student in the quality control, application and development lab for crop science materials. Diploma in a production unit in Frankfurt/Griesheim, optimizing a cristallisation process step.

Lab technician in the quality control lab for crop science materials.

Education as lab technician. During this period practical times in the departments Hoechst Marion Roussel (now Aventis), Celanese and InfraServ.

Angewandte Chemie, Bioverfahrenstechnik, Chemische Verfahrenstechnik, Thermische Verfahrenstechnik