Sridhar K

Achievements:

• Successful completion of 20+ Formulation products(Oral solids) till filing including ANDA (NCE-1)and 505 b(2)/NDA submissions.
• Played Key roll for 5 Products Pre-Launch activities from PMO for various geographies like US/UK/RoW markets.
• Drove team for successful tech transfer to production line(spray drier/solid dispersion).
• Completed PMO check list for product commercialization/validation batches.
• Responsible for Project Kick off and Scheduling (Gantt chart) and monitoring and life cycle management.
• Regulatory filing check list compliance for ANDA, NDA and registration batches in potential markets.
• New technology from Procurement to Commissioning(Oral films formulations), URS, Machinery, VQ, FAT, SAT and Installation at Manufacturing site as SPOC.
• Seamless coordination and smooth execution of CMO and customer projects for Internal development with due-diligence meeting delivery timelines.
• MIS and Excel dash board reporting and data analysis.
• RFQ preparation for small(FTE) and customer projects.
• Review of QTA, CDA, MSA documents and responsible for complete approval.
• CAPEX preparation and Product Grid and budget estimate for financial year.
• Liaised with API(DMF requirements) and excipient vendors for quality compliance.
• Equipment matrix and inventory control and monitory for batch manufacturing at production site.
• Product extension for CHINA market- compliance.

Achievements:

• Established and worked as PMO lead for 75+ Early phase clinical studies(Bio equivalence) for US, EU, TGA and RoW markets.
• Handled 10+ Overseas customers in US, EU, far east countries for seamless communications till project cycle.
• RLD and Clinical samples, labeling management for pre study compliance and dosing execution.
• Responsible for RFQ preparation and sponsor approval.
• Review/renewal and client approval of CDA, MSA documents(CRO)
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• Responsible for Project scheduling-IRB meetings-licensing- Dosing-Bioanalytical-statistics-CRS-CDISC requirements with QA compliance.
• Initiation of new qualification audits for new sponsor/renewal and audit compliance.
• End-to-End support/engagement to sponsor throughout project life cycle.
• Clinical samples and IMP(RLD/Test article) shipment documentation and liaison for customs clearance.

Achievements and Responsibilities

• Worked as team lead, responsible for method development and validation activities for biological matrices such as human plasma, whole Blood and Urine using LC-MS/MS detection technique.
• Lead 20 Bio analytical validations and 60 BA/BE studies analysis and report making.