• Responsible for the pharmaceutical development and manufacturing of drug products for clinical and commercial supplies in compliance with GMP and regulatory requirements
• Oversee, manage and drive the outsourced pharmaceutical activities with CMO and/or partner during development and commercialization phase
• Select appropriate formulations and formulation technologies based on target product profile and biopharmaceutical properties
• Proactively track project progress and critical path activities; continuously review project risks and issues, and develop and execute issue resolution and/or mitigation plan(s)
• Act as CMC or Product Operations team member and collaborate with multifunctional teams within Basilea and externally with partners
• Prepare, review and approve the relevant registration documentation Contribute to supplier selection & contracting as well as ordering and payment processes
• Ensure acquisition of know-how and maintaining profound expertise especially in dosage form manufacturing technologies, technology and regulatory guidelines
• Proactively track project progress and critical path activities; continuously review project risks and issues and execute issue resolution and/or mitigation plan(s)
• Author, review and contribute to protocols and reports for development, scale up or process validation in view of requirements for registration and evaluate data provided by CMOs
• Perform batch record review and pharmaceutical activities and collaborate on a Batch Release Team to ensure commercial batch release
• Organize technical visits and support audits of external pharmaceutical manufacturers

• PhD degree in Pharmaceutics or equivalent
• 5+ years of relevant experience in pharmaceutical industry with experience in solid dosage manufacturing
• Experience in managing international development and manufacturing CMOs 
• GMP knowledge in solid dosage development is a must
• Experience in outsourcing in a virtual drug development environment, regulatory documentation and CMC project management including Preformulation/Analytics is an advantage
• Experience with digital and AI tools, combined with a strong focus on process optimization and a passion for innovative ideas
• Strong organizational and communication skills, fluent in English, written and spoken, any other language is a benefit
• Proactive personality, which drives projects towards distinctive goals, as well as being able to work independently and collaboratively in a team environment
• Willingness to travel abroad from time to time

Basilea is committed to putting people first. In addition to competitive remuneration, we offer the opportunity to work on inspiring, cross-functional projects in an engaging working environment. We strongly believe that every employee can make an impact and is vital to our success. 
If you wish to become part of a company that strives to make a difference to the lives of patients worldwide, we are looking forward to receiving your application. 
Additional information can be found on our website www.basilea.com.