Glenmark Pharmaceuticals ( www.glenmarkpharma.com ) is a global innovative pharmaceutical company with operations in more than 50 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development, primarily focused in the areas of oncology, respiratory disease and dermatology.
Glenmark’s Biologics Research Operations in Switzerland focus on the discovery and development of new biological entities from inception through preclinical and clinical studies. With a world-class, GMP-certified manufacturing line, our Swiss site located in the Canton of Neuchâtel is well-positioned to fully serve the company’s growth in biologics research and development. The facility provides Glenmark with a full suite of in-house capabilities necessary for early production of investigational biologics medicines, including cell line development, bioassay development and antibody engineering, as well as up- and downstream development.
Glenmark is a rapidly growing company with many exciting and challenging career opportunities. We continue to recruit talented professionals who would like to contribute to our success and who share our values of respect, knowledge and achievement.
In this role, you will manage all operational aspects of the Downstream Process linked to the production of BDS under cGMP conditions for clinical trials from phase 1 to commercial . This position will report directly under the responsibility of the Head of Manufacturing inside MSAT department .
Ensure the successful GMP production of BDS :
Manage the DSP team to ensure purification step of BDS production :
Manage stock and life of chromatography resins , ensure packing columns method and monitoring use of chromatography columns.
Ensure efficient coordination inside MSAT department (USP team, Site engineers, Warehouse team) and between DSP team and other departments (QA/QC/Technical Operational/Development)
Prepare and participate to internal and external audit inspection (Swissmedic, FDA…)
Participate and support the CMC project meeting and participate towards the tech transfer process between Development and technical transfer and QA/QC team.
Report to the GMP operations manager on a regular basis all operational issues and transmit efficiently all relevant decisions to the DSP group.
Participate in the alarm on-call rotation Facility/GMP area monitoring.