Senior Manager/ AGM - Technology Transfer (Sterile)

Manufacturing science and Technology To prepare and review scale up, engineering batches and PPQ batches protocols, reports, and batch manufacturing records of new products. To perform and review Quality Risk/Gap assessment ( Phase 1A, 1B and Phase gate 2) in pharmaceutical product manufacturing to make the products and processes more robust. Revalidation, technical trouble shooting, batch size changes, Machine changes & Alternate vendor development. As a subject matter expert, leading process & product related deviation investigation, OOS, propose CAPA & change controls. In-depth understanding of the product manufacturing process and laydown the engineering batches and PPQ batches strategy. Participate in cross functional in discussions conducted by the production, QA, QC and PTCs on shop floor to understand/identify any opportunity areas related to enhancement of manufacturing process, development, and compliances. To ensure the hypothesis studies on opportunity areas and validating it through discussion and historical product details. Site evaluation for identifying requirement of new resources, modifications/implementing new technology to support new product introduction. To review the detailed analysis of all historical data to identify opportunity areas including Product development report, validation reports, annual product quality report, market complaints, out of specification, deviations, product development report, batch manufacturing report, specifications, and design elements etc. To provide training to new joiners on job profile and department related SOPs. To conduct training to shop floor team (production and IPQA) before initiating manufacturing of engineering and PPQ batch on critical process parameters involved in the drug product manufacturing. To approve the engineering and PPQ batch documents in absence of HOD. To compile the engineering batches and PPQ batches manufacturing and analytical data. Keep the project tracker updated from initiation of project till launch for allocated projects. Coordination and support for facility and equipment qualification.

Manufacturing Network Strategy To lead review of six months capacity load, to identify possible manufacturing constraint and to work with GDSO & manufacturing to mitigate constraints. To review demand against budget and rolling forecast. Responsible for detailed production scheduling to ensure level loading based on site bottleneck and drives site commit adherence to support product demand. Monthly RCCP against unconstraint demand to workout commits. To issue weekly resource wise schedule. To reviews and monitor the Manufacturing & Packaging schedule during scheduling period to ensure schedule supports expected release dates. Responsible for Co-ordination with quality control/Quality assurance/Warehouse for in-process and finished goods batch release. To anticipate capacity issues due to new product launches and drives corrective actions. To partner with manufacturing excellence team to drive opportunities for lead time improvement and batch size increases. Responsible for implementation of scheduling software. Responsible for Program management of site transfer projects/Area change validation. To publish daily report/dashboard.