Curriculum Vitae

Founder and Owner, kodon consult GmbH, Germany.

kodon consult GmbH helps companies to commercialize their ideas in the pharmaceutical industry. With almost 30 years of experience in research, development, production, procurement and quality management in chemical and pharmaceutical manufacturing, kodon consult GmbH, analyzes the potential of innovative projects and provides a clear path forward for sourcing, development, production and packaging of active pharmaceutical ingredients and pharmaceuticals. Experienced partner for Private Equity for screening projects, acquisitions, mergers and divestments.

Professor of the Practice and Chief Operating Officer, Virginia Commonwealth University, Medicines for All Institute, Richmond, VA, USA.

Education and training of graduate students, PhD candidates and Post-Docs. Day-to-day operational steering of the Medicines for All Institute of the Virginia Commonwealth Institute. Business development and liaison to customers in the non-profit as well as for-profit sector. The institute improves access to essential medicines all over the world and works closely together with the Bill-and-Melinda-Gates Foundation (BMGF) to address supply issues in infectious diseases such as HIV, Tuberculosis and Malaria, and with industrial partners to remedy drug shortages in the United States. Ideation, development, and dissemination of new and innovative synthetic routes to significantly lower costs of raw materials. Cooperation with Phlow to reestablish API production of essential drugs in the USA as well as the creation of a CDMO business, and with USP and USAID to establish local chemical production of APIs in Africa (e.g. Rifapentine). Fundraising with FDA, USP, BARDA, and several private enterprises.
Team: Director R&D Global Health, Principal Scientist Government Contracts, Lab Manager, Director Analytics and an administrative assistant, Senior Scientists, Pst-Docs, Ph.D. and graduate students (total team: ca. 40).

Chief Technology Officer, Pharmazell GmbH, Raubling, Germany.

Governance of all R&D and Tech Transfer activities within the company network for API and FDF development. Structured project portfolio steering and screening & quoting for prospective projects, own and CMDO-based. Introduction of modern project management tools. Creation and management of a broad external network of universities and companies for technologies and initial process research. First §4 filing and preparation of first §3 filing. Highlights are first FDF dossier submission (with external partners). Introduction of a groundbreaking enzymatic process for the key product UDCA that involves five enzymes in the key step, creation of a project portfolio and management of company IP (publications, patents, trade secrets). Initiation of CDMO initiative of PharmaZell/Farmabios together with Business Development and start of several customer projects in India, Germany and Italy.
Total Team (ca. 60-70): Director R&D Raubling, Director API R&D Vizag, Director Finished Dosage Vizag, Manager Project Management Vizag, Director R&D Chennai, Director R&D Gropello. PharmaZell/Farmabios was later merged with Novasep to become Axplora.

Director and Vice President Operations and Technology and Managing Director, DSM Fine Chemicals, Linz, Austria.

Leader of DSM Pharma Production, Quality Management, Research & Development, Supply Chain Management, Sourcing and Project Management in Linz (Austria), Regensburg (Germany) and Venlo (The Netherlands).
Leadership for cultural change, and reorganization to intensify site wide collaboration in Linz, strategic analysis and optimization of product and customer portfolio in critical turnaround after the financial crisis in 2008-11. Technical liaison for customers for development and production. Total team consisted of ca. 600 on site, ca. 120 in Venlo and ca. 30 in Regensburg, total ca. 750. Direct reports: Linz: Site engineering director (CapEx projects, water treatment and maintenance), Director Analytics (including Regulatory Affairs), Director Production (three major production
buildings), Director Quality Assurance, Director Procurement, Director HR, Manager for Government Affairs and Patents and an administrative assistant. Significant improvements in productivity of existing products, RFT (right first time), supplier performance via supplier quality management system, project management,
profitability of product portfolio and employee engagement. Excellent quality track record with more than 20 customer audits per year, AGES, FDA and PMDA, PAIs and regular customer audits. Turnaround of the business unit was accomplished in 2013 after six consecutive loss-making years.
The unit was sold to Patheon LLC in 2014 and later taken over by Thermo Fisher.

Head of Operational Excellence, Corporate Senior Manager, Boehringer Ingelheim, Ingelheim, Germany.

Business Process Excellence in the worldwide pharmaceutical production network for pharmaceutical and chemical production at Boehringer Ingelheim. Governance for the successful creation and implementation of the Operations Strategy including oversight
of strategic initiatives along clear measurements. Orchestrated the worldwide launch of new products for Boehringer Ingelheim and
customer API’s, e.g., Trajenta® (Linagliptin) in the US, Japan, Mexico and Europe and its fixed-dose combinations (Jentadueto®, Glyxambi®). Designed a new approach for CDMO projects and governed implementation within the Chemicals division.

• Responsible for Business Process Excellence in the worldwide pharmaceutical production network at Boehringer Ingelheim GmbH, Ingelheim, Germany and supervisor of a group consisting of two engineers. Assistant to Dr. Hans-Jürgen Leuchs (Board of Managing Directors, Operations), and to Prof. Dr. Wolfram Carius (since 1/2009 Board of Managing Directors, Operations). Secretary of the Operations Committee, the leadership team of Operations within the Corporation. Operations team member for the development of the Corporate Strategy. Program Manager for the implementation of the Operations Strategy and oversight of strategic initiatives. Responsible for the maintenance of the Balanced Scorecard for Operations, Value Stream Mapping in pharmaceutical production and a global performance measurement and improvement system called JUMP. Matrix function. Lead a team of two corporate engineers and an administrative assistant (total team: 3).
• Project Leader for the Launch of new chemical entities for Boehringer Ingelheim and customer API’s. Directed international, interdisciplinary teams consisting of Process Development, Chemical Analytics, Quality Management and Regulatory Affairs for drug substance. Directed life cycle teams for maintenance of existing products. Leader of aproject to improve and accelerate the bidding process for new business development within Chemicals to increase precision and robustness. Project Leader of a Phytochemistry project for the development of an extraction process. Project leader Operations for the commercialization and launch of NCE projects. Member of the “Core team” for NCE projects. Responsible for the development of commercial processes and the production of drug substance, drug product and packaging. Preparation and execution of international launches of new projects, e.g. Trajenta® (Linagliptin), a DPP-4 Inhibitor for the treatment of Diabetis type II in the US, Japan, Mexico and Europe and fixed-dose combinations. Leader of international and interdisciplinary teams for the preparation of the CMC submission part and the preparation for launch including supply chain design, risk management and regular reporting to upper management. Matrix function.

Technical Manager (1) and Director Manufacturing (2), Boehringer Ingelheim, Petersburg, Virginia

Provided decisive leadership and change management to pass a
critical quality audit while stabilizing and finally increasing output of production. Product portfolio overhaul. Management of Controlled Substance Production facility with extensive DEA oversight. Liaison to external customers for custom manufacturing projects and directed successful scale-up of a customer manufacturing process for a controlled substance.

1. Directed 24/7/365 operation consisting of ten production, two milling bays and a pilot plant in four different buildings. Lead four shifts consisting of 20 chemical technicians each plus one supervisor, six process engineers and one technical manager, one production support chemist, one Operations Manager and an administration assistant (total team: 94). Product portfolio included finished API and controlled substances. Oversight of adherence to all regulations, i.e. DEA, cGMP, ICH, OSHA etc. Significant improvements in quality, housekeeping, safety and throughput. Several successful audits from authorities (e.g. FDA, PMDA) and customers. Budget responsibility of more than $9 Mio. Completed the international technical transfer of a multi-ton multi-step product (Telmisartan) including trouble shooting. Served as the liaison to external customers for custom manufacturing projects (finished API), including feasibility evaluation and local bidding process for new projects. Directed start of one international technical transfer (Dabigatran) from the localside. Liaison to external customers for custom manufacturing projects and directed successful scale-up of a customer manufacturing process for a controlled substance.
2. Lead a pilot plant and a kilo lab with three process engineers and three chemical technicians as well as a pilot plant manager, two chemical labs with three Ph.D.’s and five chemists scientifically supporting the chemical operations on site (total team: 15). Responsible for two technical managers and nine process engineers to maintain production operations on site. In charge of product transfers of new chemical entities to the site. Establishment of the new group, including organization of the group and definition of interfaces to the internal customers. Roll-out of a sigma six initiative and oversight of a production-oriented six sigma project portfolio. Scientific and operational maintenance of more than eleven multistep processes.

Lab Manager for Process Development, Boehringer Ingelheim, Ingelheim, Germany (1) and Richmond, Virginia (2).

Demonstrated leadership for the challenging development and delivery of API`s in time and in full (e.g. BILN 2061, BILR 355) for clinical development programs.

1. Directed three up to six lab technicians for Process Research & Development, Budget: ca. 600,000 DM (total team: 3-6). Development of a new salt form for Telmisartan Sodium Salt, lab investigations for the identification of critical parameters (process validation) and the development of a significantly streamlined, cost-saving and viable chemical route to the fifteen-membered heterocycle BILN 2061. First reported metathesis reaction with a soluble catalyst on production scale.
2. Lead an organization for the start-up of a new chemical research and development lab with one Ph.D., one safety engineer, one analytical chemist and two lab chemists (total team: 5). Development of a new chemical route for the anti-HIV candidate BILR 355 including scale up and transfer to manufacturing. Start-up of a Chemical Process Safety Testing Unit consisting of one engineer. Technical transfer of early steps to international Fine Chemical Industry.