Team Leader/Senior Team Leader - Formulation Development

Job Description

Designing the developmental strategies for assigned products Perform feasibility assessment of new projects. Collation of developmental data for justifying the product requirements Assigning the daily activities to the team to meet the timelines of the project Co-ordinate with the analytical development to ensure the availability of development data Co-ordinate with sourcing department for the timely availability of materials for progress of the development activities. Co-ordinate with licensing department for the availability of licenses for submission batches. Co-ordinate with technology transfer/manufacturing department for smooth transfer of new products from Research and development to commercialization. Responsible for addressing regulatory deficiencies in co-ordination with cross functional teams. Preparation, approval & implementation of SOPs and relevant training activities & records. Calibration and qualification of equipment and instruments of Formulation Development Department. Ensure the compliance to the laid down systems and procedures by the team members. Ensure that the team members follow Good Documentation Practices, Quality Management systems such as Change control, deviations for continuous compliance. Responsible for designing experimental design (DoE) – composition and process optimization, statistical analysis, defining design space, statistical data interpretation and report preparation. Responsible for preparation of PDP and PDR.