Swarappa Bhojaraju
Amarapuram,Andhra Pradesh
Summary
Results-driven Upstream Manufacturing Professional with 7 years of experience in biopharmaceutical production and sterile operations. Proven expertise in optimizing manufacturing processes, improving operational efficiency, and ensuring compliance with GMP and quality standards. Skilled in upstream processing, inventory management, process monitoring, troubleshooting, and cross-functional collaboration. Adept at implementing continuous improvement initiatives, maintaining high-quality production standards, and adapting to evolving operational requirements. Recognized for strong problem-solving abilities, attention to detail, and a commitment to achieving production and organizational goals.
Overview
2
2
Languages
7
7
years of professional experience
Work History
Production Specialist
Dr Reddys Laboratories
04.2024 - Current
- Issuance of BMR from QA and Batch RM from Warehouse.
- Operation of fermenters (5L(Wave bioreactor), 50L, 200L and 1000L) like Bag installation, Pressure hold test, Media intake, Inoculation and batch monitor through out the batch.
- Operation of Depth filtration for harvest.
- Operation of Single use mixers (200L and 1000L) for media and feeds preparations.
- Sampling of bioreactors like Cell count analysis by Automated cell counter, Osmolality analysis and PCO2 & pH analysis by BGA. submitting for QC analysis (daily samples, EOF samples).
- Cleaning, Assembly preparation and Operation of ATF for Perfusion.
- Doing filter integrity test analysis for hydrophilic & hydrophobic filters.
- Shake flask expansion (Vial thaw and passage activities), Inoculum transfer.
- Preparation of Bulk harvest samples under biosafety cabinet.
- Review the batch records and Manufacturing Orders(PasX), Materials procuring (Through Purchase Request) and SAP posting after completion of Batches.
- Change control, SOP, MBRs and Protocols preparation.
Jr-Executive
LAURUS BIO Private Limited
08.2022 - 04.2024
- Issuance of BMR from QA and Batch RM from Warehouse.
- Operation of Fermenters (250L and 5KL) through SCADA for CIP, SIP, Media Preparation, Sterilization, Batch Inoculation, Fermentation, Feed addition and Batch Harvesting.
- Handling of different Unit operations like Cell separation MF.
- Cleaning of Process Vessel, Dosing vessel and Media vessel (CIP and SIP).
Jr. Executive
BIOCON BIOLOGICS Limited
08.2021 - 08.2022
- Adherence to strict quality standards as per SOP and GMP guidelines.
- Issuance of BMR from QA and Batch RM from Warehouse.
- Issuance, Execution, Retrieval and Submission of online BMR to QA as per GDP.
- Maintaining the online parameters of fermentation and recovery process as per the BMR.
- Operation of Fermenters (20L, 50L, and 500L Single use Bioreactors & 2KL SS Bioreactor) through SCADA for CIP, SIP, Media Preparation, Feeds Preparation, Sterilization, Batch Inoculation, Fermentation, Feed addition, IPQC and Batch Harvesting.
- Aseptic sampling of Fermentation samples for timely observation of growth parameters like pH, VCC, Osmolality, Glucose and pCO2.
Supervisor
KEMWELL Biopharma Private Ltd.
07.2019 - 07.2021
- Shake flask expansion (passage activities), Inoculum transfer. 80L, 400L and 2KL Bioreactors & 20L Single use Bioreactor.operations.
- Bioreactor operations (CIP, SIP, Pressure hold test), preparation of Batch activities, sterilization & cleaning operations. Preparation of media for bioreactors as well as Feeds (nutrients, amino acids, asparagine etc.) &Buffer preparations, filtration.
- Sampling of bioreactors, submitting for QC analysis (daily samples, EOF samples).
- Doing filter integrity test analysis for hydrophilic & hydrophobic filters. Cell count analysis by counting on haemocytometer.
Education
MSc - Biotechnology
KSOU
Mysore01-2023
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Government Degree college
Anantapuram01-2019
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Sri Satya Sai Jr College
Anantapuram01-2016
Secondary School Certificate - undefined
Basavanahalli01-2014
Skills
Aseptically inoculation of Fermentation and successfully running the batches as per BMR
Media optimization and parameter changes in scale up bathes for high yield production
Involved in various types of bio similar therapeutic and non-therapeutic production
Shop floor activity in the cGMP environment and maintain the process area as per cGMP requirements
Online completion of BMR and supporting documents
Experience in fermentation in Clinical trials, PPQ batches & commercial scale
Strict adherence to set quality standards in the area of responsibility
Delivering technical training to trainees and teammates
Handing of filter integrity tester and program creation according to the filter
Hydrophilic, hydrophobic Filter integrity’s
Handling of different products(Molecules) like Trastuzumab, Bevacizumab, Abatacept, Pembrolizumab, Rituximab and Nivolumab Trypsin, IGF and Human Albumin in Microbial fermentation
Handling of Change Control
Timely submission of TI sheets and BMR to QA
Protocols, SOPs & BMRs Preparation and Revision
Involved in Equipments IQ, OQ and PQ
Process improvement
Manufacturing operations
Priority management
DECLARATION
I hereby declare that the above-given details are true to the best of my knowledge and belief. Place Sincerely Date Yours ( S.Bhojaraju )
Timeline
Production Specialist
Dr Reddys Laboratories
04.2024 - Current
Jr-Executive
LAURUS BIO Private Limited
08.2022 - 04.2024
Jr. Executive
BIOCON BIOLOGICS Limited
08.2021 - 08.2022
Supervisor
KEMWELL Biopharma Private Ltd.
07.2019 - 07.2021
Secondary School Certificate - undefined
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Sri Satya Sai Jr College
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Government Degree college
MSc - Biotechnology
KSOU