Ranjit Kumar Gurram Email & Phone Number

Hyderabad, In

Hyderabad, Telangana, India

•Design of experiments with respect to standardization of intermediate process steps.•Process Improvement in terms of Yield and purity.• Recombinant Live Attenuated Zika virus vaccine development - Optimization of process for propagation of Zika DONS3 virus in CS-10’s & bioreactor. Stability studies for Drug substance. Freeze thaw studies for DS and Technology transfer for Zika vaccine production.• Varicella Zoster virus vaccine development - Process development and Scale-up and PCT material generation using VZV ROka Strain.•SARS CoV-19 virus vaccine development - Execution of batches for development of production process using Live virus and Inactivated virus for manufacturing of drug substance.•Dengue virus vaccine development - Execution of stability studies for Drug substance & Drug Product. Execution of Freeze thaw studies for DS.•Inactivated KFD Vaccine development- Process development and Optimization. • Process development and Optimization of vaccines – Chickengunya/next FMD and Rabies glycoprotein.•Recombinant Anti-Rabies Monoclonal antibodies (RVC-20 & RVC-58) development - Execution of Media optimization studies & Process optimization & Scale-up at bioreactor scale for expression of RVC-20 & RVC-58 Mab’s.

Hyderabad, Telangana, India

•Managing/co-ordination for the In-process activities related to Bulk manufacturing activities of Measles and Rubella as per cGMP requirements.•Developing operational procedures to increase the efficiency for implementing process standards and ensuring adherence to preferred standards. •Supervises a team of colleagues with appropriate planning and resource management to execute the deliverables for function. •Co-ordinate effectively across teams to resolve a complex issue and drive new initiatives with concerted effort. •Preparation, and review of SOP’s, BPR’s, MFR’s, Protocols, Reports and acceptance of process. •Preparation and review of Process Validation, Cleaning Validation and Product Change over protocols, Compilation of results and preparation of Study reports. •Responsible to make planning and execution of Validation study protocols (Facility, Equipment, Process) as per approved schedule and closure. •Handling and tracking of QMS elements through Track wise® software application(Change controls, Action items, Deviations, Investigations and CAPA). •Responsible for the facility readiness and liaison for the regulatory and client audits. •Online Review of Batch Production Records, Laboratory control records, Log books and General Control records for compliance. •Train and Supervise Operators and Executives on SOPs through LMS (Learning Management System).

Hyderabad, Telangana, India

•Participated in successful completion of Rota virus process validations and other commercial stock Pile batches without any sterility failure and non-compliance in entire year.• Actively Involved in Room Bio Decontamination Validation (PQ) studies using Bio quell equipment (VHP Generator).•Involved in Qualification (IQ/OQ/IOQ and PQ) studies for new Equipment’s and Instrument’s. •Assisted in preparation of Study Protocols, ROR’s & Reports and actively involved in facility modification, qualification, requalification, validation activities.•Involved in development studies on scale up and handling TCF’s, Roller bottles and Cell stacks (CS-1, CS-10) for Vero cell propagation.• Assisted to QMS team for on time closure of deviations, change controls and CAPA’s.• Responsible for upkeep of the production area and online documentation. •Responsible to prepare and maintain of documents (SOPs, BPRs, Logbooks and GCR’s) related to R-DS production and Related activities in the department.•Responsible to make schedule s and verifications of EMP, Calibration, Validation and Preventive Maintenance.•Ensure availability of materials (Raw materials, Consumables and Sterile materials) required for the batch on time.•Monitor the cleanliness of production areas and ensure correct disposal of waste generated in area.•Ensure compliance of CIP, PHT and SIP equipment’s (Mixing vessels) in the area.•Ensure correct disposal of waste generated in area.•Ensure integrity of filters used in the area is done on time.•Actively involved in manufacturing of Aseptic Process Simulation batches.

Hyderabad, Telangana, India

•Involved in Vero and MDCK cell expansion activities (culture initiation, propagation, and cryopreservation of cells).•Involved in Virus propagation activities (Virus infection, Harvest collection)•Responsible to make planning and exaction of upstream and downstream process activities for Rota, Rabies, Influenza A (H1N1) bulk vaccines.•Involved in Protein Purification (Affinity Column chromatography) and Diafiltration (UFS system) activities.•Participated in Final bulk sterile filtrations, stabilization and inactivation activities.•Hands on study of Micro carrier based adherent cell culture process in bioreactor at Piolet level.•Accurate and reliable record keeping including batch records, logbooks and RST’s. •Monitor and maintain cGMP aspects of the manufacturing facility.•Ensure online updating of process activities on time in respective BPRs and other clean room documents.•Ensure monitoring and recording of all equipment’s and instruments of department.•Ensure Autoclave and DHS operations and follow procedures for efficient functioning of the equipment’s.•Monitor dispensing of raw materials and consumables required for the batch on time.•Ensure Washing, Material preparation and Sterilization activities in the area.

Hyderabad, Telangana, India

◆ Worked as data entry operator in Accounts division.

Cherlopalli,Andra Pradesh,India

Bachelor Of Education - Bed

Master Of Science - Ms, Microbiology, General

Batchelor Of Science

Intermediate Education

School Of Secondary Education

Primary Education, Microbiology, General