In view of our continued global growth we need to assure that our processes stay state of the art. For this reason we are looking for further support and recruiting our new Process Development Scientist in Meyrin/Geneva. In this position you take care of our production processes development. Reporting to the Head of Process Development your main missions are as follows: Cleaning process development (fermentation, purification, dried process) and production support on pharmaceutical processes (including industrial transportation and tech transfer for pharmaceutical processes) Provide the necessary support to production to ensure the robustness and the improvement of current processes Act as expert on theoretical and applied knowledge of biologics dried forms process and formulation development, and current international guidelines (GMP, ICH, ISO) Plan and perform manufacturing trials in collaboration with the concerned departments and where necessary with partners or subcontractors that you select Technical project management Write protocol, reports, SOP and technical parts of the CTD Acquisition and management of technical knowledge (Pharmaceutical development, processes and equipment) Contribute to maintain a state-of-the-art pharmaceutical development laboratory Promote operational excellence in pharmaceutical development (LEAN 6 Sigma). Adhere to all measures for protection of health and environment which are in the area of responsibility.
The ideal candidate will have a Master degree or PhD in the pharmaceutical field in addition to the following: At least 5 years experience in process development for biologics dried forms No less than 3 years experience in cleaning process development/validation Minimum of 2 years experience in industrial transposition and in pharmaco-technical characterization of dried forms Experience in analytical development and implementation of processes, project management, risk analysis and root cause analysis as well as in CTD writing would be assets Experience in engineering of biologics manufacturing equipment would be an asset as well Fluency in French and good knowledge in English are a must
You describe yourself as a methodical and organized person who is rigorous in the traceability of Project Management activities. Being a team leader who runs projects according to pharmaceutical guidelines, you enjoy working in true collaboration with the team. Having a creative mindset you want to have an impact with innovative ideas and to discuss these with people from different backgrounds.If this sounds like you please do apply to this new position with us at OM Pharma in our headquarters in Meyrin/Geneva.