Scientist Analytical Project Lead
il y a 3 semaines
In the Clinical Release and Stability (CRS) team, we are looking for a Stability Project Owner (scientist).
The Clinical Release and Stability (CRS) team is a critical part of the Analytical Development department in the Discovery, Product Development & Supply (DPDS) organization within Janssen R&D and strives for a fully scientific understanding of the stability behaviour of Drug Substance (DS) and Drug Product (DP) for small molecules and new modalities by designing, execution and interpretation of tailored stability studies. Additionally, CRS is responsible for (non-) clinical release and manufacturing/characterization support of DS and DP from phase I up to registration.
In this role, the CRS Stability Project Owner will be assigned to several development projects for which you will handle all related CRS aspects and will be the 'go-to' person when it comes down to stability and release related questions for the assigned development projects.
key responsibilities
Design and coordinate experiments to evaluate the chemical and physical stability of new product. Collaborate closely with internal and external laboratories in Europe, USA and India to ensure right-first time execution. Provide insights in the long-term stability of drug products using predictive modelling as well as traditional stability testing. Perform data trending with advanced visualization tools (e.g.Tableau). Represent our group in the cross-functional analytical team where you work together with the analytical project leader and other analytical functions to translate the project needs into deliverables such as development, characterization, and release testing support. Communicate, discuss, and report the stability results with stability experts, the cross-functional product team and higher management. Global project coordination as your projects often span offices and time zones. Manage analytical investigations and deviations. Ensure compliance with all relevant regulations, GMP and safety.qualifications Master's degree in chemistry, Bio-engineering, or Pharmaceutical Sciences, or equivalent through experience Profound knowledge and experience of analytical techniques required for drug substance and drug product characterization. Strong planning and tracking skills, well organized and capable of handling multiple projects with respect to priorities and resources Excellent organization, communication, presentation skills in a team setting. Flexible and adapt quickly to constantly evolving business needs Good written and verbal communication skills in English language Practical experience in industry and knowledge of GMP regulations are an asset · "Can do mentality" and taking full ownership of your work Preferred Skills: Project Management Dutch is a plus
key benefits You can fill this position through Randstad Professionals as a consultant In return for your performance and flexibility, we offer you a salary package with some interesting extras, such as Gross salary according to your experience Lunch vouchers of €7 per day worked Net remuneration of €80 per month Company car with fuel card (subject to conditions) or Mileage allowance Hospitalisation insurance 1 extra day's holiday per month worked End of year bonus Pension Plan ECO vouchers worth €250 (on an annual basis, pro rata) Training opportunities
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