Mahadeo Limkar

Assistant Manager (Upstream Manufacturing) @Serum Institute Of India Pvt. Ltd

Pune, IN

Currently managing a upstream team of 12 people for manufacturing of rhu EPO•Worked on projects like ChAdOx1 nCoV-19 corona virus vaccine, Novavax COVID-19 Vaccine•Coordinated the Drug Substance Manufacturing (Upstream process) team activities in safe and cGMP/ regulatory manner in a facility having huge production capacity of 24KL (6 x 4KL Bioreactors) volume•Assist in leading the manufacturing team in such a way that both individuals and as a team they are engaged, motivated, enabled and empowered to achieve the manufacturing schedule• Working in Recombinant Vaccines manufacturing department•Provide oversight of cGMP activities within upstream processing area•Supervise and/or delegate supervision of all upstream manufacturing activities•Qualification of single use systems i.e. Single user mixers, Single use Bioreactors (CSR system Make:ABEC, PALL Bioreactor, Sartorius STR Bioreactor, Cytiva XDR), Wave Bioreactors (Make: Sartorius & Cytiva)•Cross functional coordinator with other departments (Engineering, Utility, QA, QC etc) to ensure manufacturing area and equipment are maintained in a state of inspection readiness •SME/Reviewer for SOPs, BMRs, BOMs etc•As a Trained Trainer, train, coach and mentor. Help to provide guidance and support for less experienced members of the team, knowledge transfer •Proficient in eDMS, CMMS(Computerised maintenance management system), Trackwise change management system, Ample logics, Microsoft Word, Excel, WinCC SCADA, MFCS etc

MVP Samaj's College of Pharmacy, Nashik

Bachelor of Pharmacy (B.Pharm.)

Institute Of Chemical Technology

Master of Technology (M.Tech.)