Scientist, Injectable DP process development
Contracting – Brabant Wallon
Your responsibilities:
- To support activities for defining and selecting drug product manufacturing processes and components for clinical manufacture
- 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 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
Your profile:
- Bachelor’s degree in Sciences
- Minimum 2-3 years’ experience in liquid drug product development and/or manufacturing within the pharmaceutical industry is required.
- Experience within the biopharmaceutical industry is an advantage
- Knowledge and technical experience in parenteral 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.
- Scientist grade
Our offer:
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
