While in this role, I promote products mainly to the US, with an initiative in progress to expand into the European Union. I’ve conceptualized and devised new treatments for toxoplasmosis gondii and orphan indications where no medical treatment is available today. Lastly, I retain several onsite research and development department collaborating with external partners.My most notable achievements: ➜ Delivered 50% cost savings for late-stage development after outsourcing and directing the existing and new active pharmaceutical ingredients (API) and drug product (DP) formulation activities from the pre-clinical to the commercial phase.➜ Supplied present/future value CMC information (execution m2 and m3 module) by creating the documentation for investigational new drugs (IND) to support the FDA approval for clinical studies for three programs.➜ Expanded operations across four sites by assessing and incorporating new contract manufacturing organizations (CMOs).➜ Obtained approval for programs enabling the product to undergo clinical trials and be commercialized by developing processes, devising analytical methods, and organizing experimental designs.➜ Averted potential fines/censures stock out situations or supply interruptions by supporting QA and RA and external partners during quality investigations and routine production.

As the head of the technical alliance, I revolutionized the origination of pharmaceutical products in the gastroenterology field. I served as the single point of contact between the company and external global API and drug product manufacturers. I also led a five-person interdisciplinary staff responsible for a budget, purchasing APIs, outsourcing DP processes, and troubleshooting. I secured a reliable supply of products, implemented new API sources and DP sites, and supported API and DP-focused R&D activities with cross-functional teams. High-level successes include: ➜ Spearheaded a multi-million-CHF project and a cross functional team while acquiring new drug product and completing the drug’s tech transfer from an existing supplier to a new CMO.➜ Obtained approval for programs enabling the product to undergo clinical trials, be commercialized, and opened a second manufacturing site for supply security after transferring and validating a five intermediate drug product formulation process.➜ Secured approval from European countries within five years, ensuring uninterrupted supply after acquiring a product for manufacturing by leading the auditing, technology transfer, validation, and supporting submission of information to regulatory authorities.➜ Attained European approval for a 2nd manufacturing site for existing products by investigating the production problems, implementing process improvements, and completing process validation.➜ Surpassed the scheduled period by 12 months for implementing the new ICH guidelines Q3D by proactively incorporating all external manufacturing partners, API, and drug product sites, including collecting data and conducting analytical testing.

As the head of research and development, I managed and supervised a team of 20, focusing on chemical development, technical transfer of the processes, and production support. Additionally, I directed a range of tasks, including API and intermediates, fine chemicals, and building blocks to monomers and polymers, the entire spectrum of organic compounds from pharmaceutical, agricultural, textile, and specialties of the electronic industries. Lastly, I managed several personnel issues to create a more stable department and integrated standard management tools for resource planning, timeline control, and project budgeting.Noteworthy achievements include the following:➜ Engineered to secure a multi-million CHF program by effectively establishing corporate trust through completing a high-value project with a new customer, where trials showcased collaborative efforts and exceptional performance.➜ Doubled the capacity efficiency by transitioning from single to parallel reaction steps, allowing for up to 35 per week change in people’s mindset and laboratory technology while handling new and ongoing initiatives and processing customer samples.➜ Won requests for proposals, demonstrating excellent financial and quality performance for customers by creating a marketing strategy to provide samples to desired specifications and utilizing cost-effective synthetic route ideas that simplified production.