Ravindra Reddy

● API product portfolio lifecycle management contains over 100 products for China Market.

● Managing activities in product lifecycle like, API Development, Validation, Regulatory filing, Approval and Amendments submission.

● API product selection and calendar preparation for China DMF filing.

● API product delivery management for Formulation customers of both Internal and external parties.

● Conducting weekly meetings with CFT and writing the MOM’s (Mfg,plantes, R&D centres, RA, CQA and BD teams).

● Action points tracking, and issue escalation to senior leadership team for early resolve.

● API portfolio tracker management.

● Monitoring Registration testing activities (NIFDC, PIFDC), and supporting by collection or procurement of Columns and samples for on time submission.

● Providing Administrative documents for product filing.

● Providing support to R&D teams for sample procurement and collection of materials from Vendors.

● Closely Monitoring All the deficiency related activities to ensure on time deficiency response submission.

● Customer Communication on product filing status, progress and informing on changes, Amendments.

● Leading and guiding the team to achieve the best results.

• Conducting internal and external kick-off meeting with the CFT’s and clients, to discuss the scope, timelines and assessing the risks and challenges in the project
• Preparing and Mainting project management documents like Project Charters, micro-level Gantt charrts, issue log, risk register, Escalation sheets, change log etc.
• Getting the budget approvals for capital expenditure of the project and coordinating with the team for procurement requirements (Additional RMs and equipment)
• Conducting Scrum meetings with the CFT’s and circulating the action item tracker daily basis
• Conducting Walkthrough and war room sessions with the CFT’s for the Technology transfer activities
• Participating in PPIC (Production planning and inventory control) meetings
• Updating the project dashboards to forecast the health of the project (Budget, Timelines, and Deliverables)
• Preparing the roadmaps for preproduction activities and circulating to the team
• Scheduling the customer meetings and presenting the progress of the project
• Participating in PRM (Project review meetings) with the management team to present the status and key issues of the project
• Monitoring the Project P&L (Profit & Loss)
• Registering the delays in the project and escalating to the senior leadership team for additional support
• Sharing the project updates to the customer on daily, weekly basis
• Registering the key learning’s of the campaign and presenting them in project closure meeting
• Accomplishments:
• Delivered more than 10 manufacturing and development projects with >80% OTIF
• Successfully delivered a Validation project includes the scope of process Validation at Lab scale, Analytical method validation and Manufacturing validation activity
• Hands on experience in managing European, American and APAC customer projects
• Hands on experience in managing Big pharma project