Senior Research Officer - Downstream Process
Glenmark Pharmaceuticals ( www.glenmarkpharma.com ) is a research - led, global, fully integrated pharmaceutical company. The group is present in more than 90 countries including the USA and Europe. Our Swiss operation encompasses the Company's Biological Research and Development Centre located in the Canto n of Neuchâtel and focuses on the discovery and development of novel biological entities comprising monoclonal antibodies and proprietary bispecific format. Senior Research Officer Downstream Process RESPONSIBILITIES: ? Manage the scale - up of processes to phase III and commercial. Proceed to tech - transfer with manufacturing organizations (internal and external to Glenmark) with appropriate documentation. ? Support manufacturing campaigns as subject matter expert. ? Manage the design and execution of process characterization/validation studies. ? Design and manage viral removal/inactivation studies. ? Support the scale - up of processes to phase I/II clinical development scale. ? Actively participate in the introduction and implementation of new technologies and proc ess improvements, ensure compatibility of development and manufacturing systems. ? Actively participate in budget forecasts, planning and resource mapping ? Support for on - going process improvement of post - phase I manufacturing processes as part of the life c ycle management. ? Provide active support for regulatory submissions ? Perform other related job duties as required. ? Experience of scale - up and/or process characterization/validation for Phase III and commercial processes is required. REQUIREMENTS : ? PhD , Master or Bachelor's degree in chemical or biochemical engineering, or related discipline plus minimum 3 - 5 years of relevant exper ience, in an industrial setting ? Hands - on experience in scale - up, troubleshooting and validation for Phase III and commercial p rocesses ? Hands - on experience in process development and process optimization. ? Scientific curiosity along with active and independent problem solving capabilities ? Excellent organization and planning skills ? A highly developed team spirit and an ability to work with flexibility and independence in a changing and demanding environment ? Fluent English is required, French is highly desirable.