Venugopal V Durvasula Ph.D. PMP®

* Led cross-functional project teams from initiation to post-filing, coordinating with PD, RA, Clinical, IP, Finance, and Manufacturing functions. * Initiated and managed project infrastructure including PR, ION, NDC, and NC number requests; established shared folders to streamline team collaboration. * Planned and facilitated Kick-off, Pre-PSC, PSC, and TSG meetings (TSG3 – Pre-registration, TSG5 – Pre-filing, TSG6 – Postfiling/ Launch); tracked risks, timelines, and action items. * Created and maintained detailed project budget files; worked closely with the Finance team for expense reconciliation, quarterly re-forecasting, and monthly reporting. * Oversaw procurement and PO creation for API, RLD, excipients, components, and tooling; ensured vendor setup and timely material availability. * Collaborated with medical and clinical teams to align on regulatory and clinical trial requirements, including NDA/ANDA dosing schedules and timelines. * Supported post-submission technology transfer processes in partnership with TS PMs; managed risk register handoff and launch preparation tasks. * Drafted and routed discontinuation memos; ensured timely communication and documentation flow among stakeholders. * Used MS Project (PWA), Excel, SharePoint, and OneNote to track project deliverables, maintain documentation, and support real time collaboration. * Conducted regular alignment meetings with Procurement, QC, and Manufacturing to monitor status, mitigate risks, and support batch readiness.

• Led strategic site projects, ensuring on-time delivery within scope, function, and budget. • Fostered a culture of cross-functional collaboration and open communication, contributing as a valuable team member. • Partnered with global functions to build a forward-thinking, customer-focused site, overseeing capital project delivery from design to licensed facility. • Managed contractor and supplier relationships, played a pivotal role in evolving design standards, and applied agile principles and technology advances. • Provided sponsorship to leaders responsible for technical disciplines, ensuring project success. • Developed and managed a leadership team capable of engaging employees to achieve company goals. • Supported the project head in organizational design and staffing decisions, promoting high employee engagement and a positive work environment. • Forecasted capital and operational expenses with high accuracy, calculating cost performance indexes for budgetary estimates.

• Led R&D experiments, data analysis, and documentation for process development and technology transfer. • Managed API technology programs and coordinated project timelines and updates. • Delivered project leadership through effective planning, reporting, and client communication.

• Managed multiple projects with tight timelines, excelling in project organization and coordination. • Led the pilot plant building project from design to execution and closure. • Contributed innovative ideas to enhance the organization's safety culture. • Expertise in all production planning and scheduling phases.

- Led the successful delivery of 14 complex projects, including beta-lactams, macrolides, polypeptides, and SGLT2 inhibitors, in both Analytical and Synthetic divisions. - Conducted comprehensive literature searches using Reaxys and SciFinder to select and understand synthetic schemes, preparation methods, properties, and spectral characteristics. - Managed and coordinated cross-functional teams, including R&D, Supply Management, Operations, Quality, and Engineering, from development through validation and commercialization. - Oversaw all phases of project management, from initiation through execution, monitoring, and conclusion, ensuring the achievement of project objectives and efficient resource management. - Ensured product and process robustness and consistency, supporting the implementation of cGMP, Risk Assessments (e.g., FMEA), Continuous Improvement, and Lean Manufacturing techniques. - Developed and maintained technical knowledge and in-depth skills related to processes and equipment, contributing to the successful development and validation of synthetic processes for drug substances and drug products. - Analyzed testing data, entered results into the company's electronic system for certificates of analysis, and prepared timely reports as required. - Authored and reviewed technical data, documents, SOPs, and proposals, ensuring accuracy and compliance with industry standards. - Coordinated method transfers between manufacturing locations, R&D, and RM/Finished Products departments, facilitating smooth transitions and maintaining process integrity. - Assisted in failure investigations, designed investigation protocols, and suggested corrective actions, including leading or assisting in the preparation of deviation reports and Corrective Preventative Actions (CAPA) in response to testing failures.

Analytical division Handling of HPLC, all the analytical instruments.