Formulation Development Expert

In this position you will become a member of our R&D group. You will have direct impact on the development of diverse formulations of our biosimilar products.

• Supporting drug product development strategy planning
• Planning and execution of experiments
• Mentoring for junior staff
• Collaboration with other departments involved in process/product development and further life cycle (e.g. Upstream, Downstream and Analytical Development Departments, Quality Control, Quality Compliance, Technical Operations)
• Collaboration with IP department on formulation patent searches and patent applications preparation
• Supporting preparation of regulatory documentation
• Representing company during inspections, audits and meetings with regulatory agencies (FDA, EMA)
• Storing and managing data according to GDP and internal procedures
• Writing reports according to the internal procedures and best scientific writing practices
• Presentation of experimental data during team and/or department meetings
• Performing literature searches to address challenges or to seek improvements

• Degree in pharmacy, biotechnology, chemistry or other life sciences
• Minimum 5 years of track-record experience in biologics formulation development (liquid and lyophilized forms; most preferably in the field of monoclonal antibodies)
• Experience in early to late phase drug product development
• Experience in analytical characterization techniques used in biopharmaceutical R&D (e.g., DLS, SLS, DSC, FTIR, DSF, chromatography, UV-Vis, viscometry)
• Ability to independently plan and execute experiments and deliver results within required timelines and quality
• Excellent organization (incl. good writing) skills to deliver reports on time and with appropriate quality
• Effective communication and good presentation skills to update team members on the project progress
• Ability to search literature and draw conclusions
• Pro-active attitude and willingness to contribute to the development of the group
• Ability to work independently as well as a strong team player
• Ability to collaborate on cross-functional projects
• Practical knowledge of MS Office and statistical software (e.g. JMP)
• Fluent English