Secunderābād, Telangana, India
Specialties: Mammalian Cell Culture, Biotherapeutics Production (Monoclonal Antibodies, Viral Vaccines Manufacturing), Single Use Bioreactors, Perfusion, Upstream/Downstream Operations
mAbs Manufacturing @ 15KL Scale, C&Q, Validation, Scale-up
Viral Vaccine Manufacturing
Manufacturing, Antigen Ad-26, Upstream Process (Covid-19 Vaccine) Leading/Managing and providing direct oversight to a team of supervisors, process experts to carry out upstream process operations to comply with various Process Trials, Engineering Runs, Qualification and Validation Batches (PPQ) and Commercial Batches as per the business requirement with all cGMP norms with in Large Scale Operation Plant (State of the Art Facility). Responsible for hiring, building as well as developing team of process experts required for carrying out various upstream related unit operations. Responsible for Technology Transfer for the production of Covid-19 Vaccine. (Mammalian Cell Culture Based- Perfusion Technology ). Managed the operational activities of assigned manufacturing projects with overall responsibility of standardization of Single Use (SU) equipment/systems at (Cell Culture) Up Stream- (USP), Down Stream Processing (DSP) and Media- and Buffer (BMS) preparation. Responsible for streamlining the operations of the equipments and process execution as per the client (Johnson & Johnson) specification and process design. Representing the operational area in customer meetings, audits and regulatory inspections Responsible for staff compliance with safety, cGMP and regulatory standards. Responsible for the preparation of various internal and external audits. Review CPV plans and provided recommendations to client (Johnson & Johnson) Design and plan for the qualification of Facility Layout. Managed a team for the Qualification (SAT/DQ/IOQ)of various USP as well as DSP Process Equipments viz Single Use Bioreactors (1000L,250L-Thermofisher), Wave Bioreactors (Sartorius) AKTA Ready XL(Cytiva), PARKER Filling Station etc. Preparation/ Review of layouts/P&IDs/URS for the Process equipment. Review of Qualification Protocols (SAT/DQ/IQ/OQ and PQ)of associated process equipments Ensuring execution of planned activity and documentation.
Responsible for Drug Substance Manufacturing Operations. Led a team of process experts to carry out upstream process unit operations to comply with production schedule with all cGMP norms. Responsible for staff compliance with safety, cGMP and regulatory standards. Design and plan for the qualification of Facility Layout. Conducted Commissioning and Qualification of 2000L Bioreactors (Sartorius) and associated Single use Seed Bioreactors and its integration to Process Control System (PCS) by Seimens which includes: Preparation/ Review of layouts/P&IDs/URS for the Process equipment. Preparation/Review of Functional Design Specifications (as per ISA 88 standard) Authored as well as Review of Commissioning and Qualification Protocols (DQ/IQ/OQ and PQ) Involved in FAT/SAT of the process equipment 2000L Bioreactor. Ensuring execution of planned activity and documentation. Authoring as well as review of various validation and study protocols and reports viz: Process Validation, Cleaning Validation, Kla Study, Temp Mapping etc. Audits Faced- USFDA, EMEA Led a team for Quality Management System Activities viz: Timely Closure of deviations with proper investigation and effective CAPA implementation. Effective Investigation and closure of various OOS limits. Highlights Certified on Six Sigma Green Belt (Indian Statistical Institute, Bangalore) Standardizing Manual Cell Counting Method. Certified on Six Sigma Green Belt (SKILL ACADEMY, Bangalore) Contamination Reduction
Responsible for Drug Substance Manufacturing Operations. Leading a team of process experts to carry out upstream process unit operations to comply with production schedule with all cGMP norms. Responsible for staff compliance with safety, cGMP and regulatory standards. Commissioning and Qualification of various equipments and instruments of large scale Cell Culture Manufacturing Facilities viz upto1000L Bioreactors (Bioengineering Bioreactors) etc by preparing and executing IQ/OQ and PQ protocols. Trial Runs and Validation Run for 1000L Single Use Bioreactor (Cytiva) using Perfusion Technology( ATF Technology -Repligen) Assisted in the development of processing plans, methods, design for the large scale bioreactor facilities. Responsible for taking up water trials and engineering runs in the bioreactors in preliminary phase of qualification Responsible for carrying our Process validation and Cleaning Validation Batches by developing and executing process and cleaning validation report