Responsibilities:

• Operational technical ownership to ensure product quality and reliability.
• Takes active role for Technology Transfer, ASQ (Alternative Supplier Qualifications), Capacity Expansions projects.
• Drives continuous improvement projects, process and formulation improvements, (remediation, development and validation) and responds to technical issues resulting from quality, manufacturing, and / or regulatory to ensure product reliability and cost leadership.
• Participate and provide formulation and process-based guidance to validation studies examined for existing or new products manufactured by TPMs.
• Find a solution to manufacturing problems or any other issues to maintain a robust flow of finished products from TPM to avoid any potential back orders.
• Participate and monitor the validation studies of the new products, provide feedback and secure the compliance of the validated parameters.
• Review documentation / product samples shared by TPM and assess the risks associated with the manufacturing of the product under the Company Logo.
• Reviews and approves validation protocols/reports, technical development and justification reports.

Requirements :

• Bachelor’s degree in Pharmacy, Chemical Engineer, BioTechnology. Master’s degree or PhD is preferred.
• 6+ years of experience in the Pharmaceutical Industry, preferably in R&D and Manufacturing, is required.
• Excellent technical know-how on manufacturing processes of solids, liquids, semi solids and sterile, formulation development experience is preferred.
• Experience in technology transfer, product scaling and commercializing.
• Process and understanding of business needs and the ability to translate them into actions to meet timelines.
• Have a good knowledge of cGMP (Good Manufacturing Practices) and about product transfer, process validation activities.
• Fluent in English is a must.