Scientist, Injectable Drug Product Process Development
Walloon Brabant - Contracting
Major Responsibilities
* 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 (e.g. filter selection and sizing, target fill volume assessment, compatibility assessments, clinical blinding, etc.) ;
* Capture and analyze 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 the client's 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.
Profile
* Bachelor's Degree ;
* 2–3 years of experience in manufacturing or production support ;
* Knowledge of fill & finish processes (even indirect) ;
* Ability to work independently after a few months ;
* Scientific critical thinking ;
* Clear and transparent communication ;
* Motivation and energy ;
* Fluent English (documents, meetings, interactions) ;
* Scientist grade.
Nice to Have:
* Experience with syringes or injectable liquids ;
* Experience working with CMOs ;
* Understanding of fill & finish steps and their impact on the product ;
* Ability to translate needs into lab language/protocols ;
* Experience writing scientific reports.
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, lunarosa.doukkali@jeffersonwells.be