Basilea Pharmaceutica Ltd. is a commercial stage biopharmaceutical company, headquartered in the heart of the life sciences hub of Basel, Switzerland.
We are an innovative and multinational team of 225 employees worldwide and committed to discovering, developing and bringing to market medicines that make a clear difference to the lives of patients. Our activities are focused on the therapeutic areas of oncology and anti-infectives, with two commercialized drugs in our portfolio (Cresemba® and Zevtera®).
In order to strengthen our Technical Operations Department we are looking for an experienced
- Responsible for the pharmaceutical development and manufacturing of drug products for clinical and commercial supplies for assigned projects and products
- Oversee, manage and drive the outsourced pharmaceutical development studies
- Select appropriate pharmaceutical development and manufacturing organizations as well select appropriate formulations and formulation technologies based on target product profile and biopharmaceutical properties
- Implement contracts and technical agreements with external pharmaceutical manufacturers and coordinate the studies to align with in-house activities
- Review and contribute to protocols for development, scale up manufacture, process validation in view of requirements for registration
- Compile, review and contribute to reports and evaluate data provided by the CDMO
- Prepare registration documentation and support requests from Health Authorities
- Interact in a project team and collaborate with multifunctional teams within Basilea and externally with partners
- Lead a CMC team, be responsible to establish and manage CMC project plan and budget, and coordinate project related activities
- Education in Pharmacy or equivalent, PhD degree and Project Management experience desirable
- Minimum of 5 years of relevant experience in pharmaceutical industry, preferably with aseptic manufacturing and lyophilization
- GMP knowledge is a must
- Experience in outsourcing in a virtual drug development environment, regulatory documentation and CMC project management including Preformulation/Analytics is an advantage
- Strong organizational and communication skills, fluent in English written and spoken, any other European language is a benefit
- Excellent IT-user skills in MS-Office, MS Project and Visio is an asset
- Proactive, interested in taking leadership and drive projects towards distinctive goals, as well as able to work independently with team orientation
- Exceptional learning ability, good relationship-building skills and able to work in a dynamic environment
Basilea is committed to putting people first. In addition to competitive remuneration, we offer the opportunity to work on interesting, 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 via our careers portal (http://www.basilea.com/Careers/).
Additional information can be found on our website www.basilea.com.
We look forward to receiving your online application including your complete documents. For additional information please contact Ms. Nadine Pfrüner.