Gopal Rajan Email and Phone Number

Lead the Global Scientific Integration team in all aspects of drug product development on synthetic portfolio from late discovery until commercialization across all drug product technology platforms in oral solid, liquid and parenteral dosage forms. Strategic guidance, accountable for scientific-technical coaching and in-depth reviews with respect to all pharmaceutical development related aspects. Closely partner and fully align with key stakeholders within R&D and supply chain and global commercial strategy organization.Accountable/responsible for various strategic initiatives and objectives, e.g., overall DPD strategy, governance, strengthening partnership/interfaces, strengthening innovative technologies (continuous manufacturing E2E deployment), and partnership and practices in synthetic Pharm development.Direct involvement in portfolio projects: (1) functional, deep-dive reviews and coaching of project development strategies within DPD; 2) as applicable, scientific and strategic support on cross-functional reviews, internally and externally; (3) Internal and external representation, L&As and external collaborations, and general scientific community; (4) direct participation in issue resolution as needed.

Combined functional CMC leader and drug product scientific Integration role, focusing on early and late development and consolidating matrix and functional responsibilities for small molecule portfolio from late discovery through commercialization. Leading cross functional matrix team on therapeutic area and compound development team strategy. Stakeholder management (internal and external) with respect to specific portfolio projects responsible as CMC L.

Define the drug product development strategy across all clinical phases including Life Cycle Management. Drive the project advancement in partnership with multi cross functional teams and the commercial organization while ensuring scientific standards are met. Deliver clinical and commercial robust formulations and manufacturing processes, meeting manufacturing performance, cost needs, in line with QbD principles. Single point of contact on the CMC (Chemistry Manufacturing & Controls) new product development teams for drug product development.Team lead -guiding and coaching a team of SIs.

Manage and direct teams within Drug Product Development function and across Janssen Sites by mentoring and providing guidance and encouragement to explore new ideas, opportunities towards process & self-improvement and towards higher performance, quality & delivering more shots on goal for all deliverable's.Organize and strategize formulation & process development activities End to End for Oral Solids (IR and MR) as per CMC stage gate deliverables and ensure successful TOO/commercialization of NDAs from RnD to commercial facilities.Ensure all developing projects, initiatives and processes are in conformance with organizations established policies and objectives, resulting in quality standards being met and exceeded. Direct management of scientific staffs across different function & sites for programs representing high growth potential, breakthrough or platform opportunities.Lead a formulation development team comprising of formulation development scientists and members of various cross-functional teams handing NDA development within Janssen which includes formulation development towards clinical phase development (Phases 1 to 3) and successful technology transfer at the Janssen and contract commercial manufacturing site. My responsibility also included with working with partners and CRO/CMOs across US and Europe for designated projects involving formulation development to technology transfer.

Deputy Manager Lead and managed a team of scientists involved in ANDA formulations for US and Europe generic market to include execution of small scale, scale up, exhibit and commercial batches on novel drug delivery systems (MR products) by patent infringement identification and working on non-infringement strategies.

Formulation and Development Worked on development of ANDA formulations for US and Europe generic market with an aim towards development, optimization, scale up, bio equivalence studies, exhibit batch formulation, documentation, etc.