Formulation Development - Technology Transfer

General Accountability:

• Technology transfer/integration, process development, process optimization, process engineering (scale up).
• Process qualification, site transfers, new product launch.

Description of the role:

• Must have exposure in tablets, capsules, pellets dosage forms for regulatory markets (US/EU).
• Thorough knowledge on exhibit and validation philosophy and should have scientific evaluation methodology.
• Participate in development phase to understand the process/technology.
• Process optimization and finalization of critical process parameters with QbD/DOE concept.
• Provide technical inputs for preparation of batch manufacturing documents (BMR/Protocol/Sampling plan).
• Preparation of scale up report and provide relevant recommendation if any.
• Review process qualification report and provide relevant recommendation if any.
• Perform gap analysis (technical) and provide technical support for site transfers/new launch products.
• Technical support for process improvement projects and trouble shooting.
• Handling of OOS/OOT/Deviation in during execution /new launch products.
• Imparting training on new products through tech transfer presentations to cross functional departments.
• Hands on experience on equipments and planning of exhibit batches.
• Sound knowledge on quality management systems.
• Technology transfer documentation.
• Identify and support the introduction of new technologies and equipment (e.g., manufacturing equipment)
• Generate Technology Transfer Data from R & D to transferring technology to Commercial Plant