Conceptualize and execute formulations development (liquid, lyophilized, high concentration etc) for Glenmark's NBE and Biosimilar products. Develop and optimize processes (UFDF concentration, Lyophilization) for Glenmark's NBE and Biosimilar products. Interact with CMO's for drug product manufacturing during different phase of product development. Prepare and help with clinical trials of Glenmark's NBE and Biosimilars. Manage formulation and forced-degradation studies. Manage long-term stability studies. Responsible for technology transfer from the formulation development group to external CMO's. Manage technology assessment and development studies appropriate for Glenmark's needs for formulation development. Interpret and report results of work carried out in written and oral format both internally and externally. Evaluate external developments in the area of formulation development and make recommendations based on their applicability for Glenmark's projects. Perform other relevant duties as required.
PhD in analytical, pharmaceutical, chemistry or biochemistry with at least 1 year of industrial experience or MSc or equivalent in analytical, pharmaceutical, chemistry or biochemistry with at least 3 years industrial experience Significant experience in protein formulation for both early and late phase development Experience in lyophilization and high concentration formulation development and process optimization Experience in technology transfer and management of drug product manufacturing Exposure to QBD and DOE principles Fluent in business-level English, both verbal and written; French is a plus Excellent communication skills and strong diplomacy skills required