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.