At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Purpose of the function
The "Manager Formulation Technology - Biologics" is responsible for the planning, organization and technical support of development activities in Formulation Technology for Parenteral Formulation and Process Development (e.g. lyophilization) incl. physicochemical characterization of Biologics (focus on oncology, e.g. ADCs). The functional and technical management of contract manufacturing organizations (CMO Management) for manufacturing parenteral dosage forms in Europe and supporting the preparation of regulatory submissions (e.g., NDA, BLA, and post-approval changes) are also within the scope of this position.
Key responsibilities
- Development, optimization and upscaling of GMP-compatible manufacturing processes for lyophilization of biologics (e.g. Anti-body drug conjugates, ADCs), incl. preparation and documentation of development activities
- Creation of risk analyses and statistical design of experiments (DoE) within the framework of formulation and process development of biologics
- Co-working with a young development team for developing and extending the department analytical capabilities with focus on physicochemical characterization of Biologics, as well as the occupational health and safety concepts for handling of high potent compounds
- Functional and technical management of contract manufacturing organizations (CMOs) for clinical trials material manufacturing, as well as technology transfers to in-house manufacturing sites and CMOs in Europe, incl. on-site support
- Supporting the team in creating and reviewing manufacturing protocols and reports
- Support the preparation of regulatory submission documents; incl. NDA, and BLA.
- Collaboration with various international multidisciplinary project teams (incl. colleagues from Japan, US and CMOs in Europe)
Personal skills and professional experience
- University degree in Pharmacy or related subject, ideally with PhD in Pharmaceutical Technology (focus on Lyophilization and Biologics)
- At least two years of relevant work experience in pharmaceutical industry (formulation and process development).
- Previous experiences with CMO management, global CMC development, technology transfer and handling of high potent Biologics are preferrable.
- Experience in Design of Experiments and upscaling of GMP-compatible manufacturing processes (Fill and Finish)
- Previous expertise in CMC regulatory requirements and submissions
- Very good written and oral communication skills in English and German
- Very good IT skills (MS Office, SAP etc.)
- Willingness to travel on business trips, if needed
