Primary Purpose / Regulatory Responsibilities: • Technical expert in the establishment of robust, fit for purpose injectable drug product manufacturing processes from toxicology studies or first in human until BLA approval. • Define and select drug product manufacturing processes and parameters for clinical manufacture. • Cooperate with a wide range of internal and external stakeholders, including contract manufacturing organizations, as part of a project team. • Design and execution of lab studies in relation to drug product development activities, capture and analyze data and author related documentation (write-ups, protocols, reports (eg filter selection and sizing, target fill volume assessment, compatibility assessments, clinical blinding, etc) • Capture and analyse critical manufacturing process data for process understanding and process characterization • Perform process risk assessments • Design DP processes for sterile injectable drug products in liquid or lyophilized powder form, in vials, pre-filled syringes or as combination products), • Define the investigational medicine product preparation process in clinical trials. • Provide support to ensure timely manufacture of stability and clinical DP batches. • Provide support to process performance qualification/validation Ensure products are manufactured in accordance with our quality system, cGMP and latest regulatory requirements. • Provide support in the completion of the relevant sections of the CMC regulatory submissions and regulatory briefing documents and response to questions from authorities. • Provide support in investigations of deviations and complaints related to DP quality. • Support knowledge transfer from late phase development to commercial for validated DP processes. • Contribute to develop the ways of working in the department Requirements - Minimum 2-3 years’ experience in liquid drug product development and/or manufacturing within the pharmaceutical industry is required. - Experience within the bio pharmaceutical industry is an advantage. - Knowledge and technical experience in liquid drug product development and cGMP manufacturing under aseptic conditions (such as vial, cartridge and pre-filled syringe filling) Is an advantage. - Technical knowledge of sterile DP development covering DP components, process transfer, scale-up and optimization is an advantage.