Fill & Finish Process Development Specialist

In this role, as a part of our R&D Team, you will be responsible for troubleshooting of drug product manufacturing, development of fill & finish process and primary packaging selection.

• Selection of biotechnological drug product primary packaging (e.g. vial, syringe, cartridge) and delivery devices (e.g. autoinjector)
• Testing and selection of operating parameters during production of drug product
• Close cooperation with Drug Product Manufacturing Dpt. on development and implementation of primary packaging fill and finish process, as well as to solve appearing manufacturing problems
• Collaboration with Formulation Development Team at Drug Product Development Department
• Planning and execution of experiments, with no need for supervision
• Data management according to GDevP and internal procedures
• Collaboration with other departments (USP, DSP, ADS, QC, QA, IP)
• Writing reports according to internal procedures and presentation of experimental data during team and/or department meetings
• Mentoring for junior staff
• Literature research to address challenges or to seek improvements

• Degree in pharmacy, biotechnology, chemistry or other life sciences
• Minimum 2 years of experience in formulation/analytical laboratory or drug product manufacturing
• Experience in various biophysical characterization techniques used in biopharmaceutical R&D (e.g. UPLC, HPLC, DSC, DLS, Fluorescence spectroscopy)
• Knowledge of various primary packaging components for parenteral drugs
• Experience in particle analysis techniques (e.g. HIAC, MFI) is desirable but not essential
• Experience in protein drug product process development is desirable but not essential
• Excellent organization with good writing skills to deliver reports on time and with appropriate quality
• Ability to perform literature search, draw conclusions, communicate and present effectively
• Ability to collaborate on cross-functional projects
• Ability to plan and execute experiments at scarce supervision and deliver results within required timelines and quality
• Pro-active attitude and willingness to learn and contribute to the development of the group. Ability to work independently as well as a strong team player
• Practical knowledge of MS Office
• Fluent English