Akash Gude
New Panvel
Summary
Skilled Downstream professional with over 6.5 years of expertise within mammalian cell culture manufacturing . A strong collaborator who effectively works with cross-functional teams to drive operational excellence and maintain high-quality standards. Committed to continuous improvement and maintaining a safe, compliant work environment.
Overview
7
7
years of professional experience
Work History
Asst. Manager
Kashiv Biosciences
Ahmedabad
12.2024 - Current
- Working in downstream mammalian suite for manufacturing of Omalizumab DS (200L scale).
- Involved in equipment qualification (AKTA Process, Chromatography columns, Biosafety Cabinet) and Downstream area qualification.
- Involved in MBR and SOP preparation for downstream processing and training for the same.
Senior Production Executive
Intas Biopharmaceuticals
Ahmedabad, India
04.2023 - 11.2024
- Working as shift incharge in downstream suite of mammalian cell culture which mainly includes products like recombinant Erythropoietin, PEGylated Erythropoietin and Follitropin (FSH) also fusion protein like Etanercept
- Involved in production of quality documents like SOPs, MPCR-BPCR revision, performance validation protocols etc.
- Took ownership of various actions within operations which includes documentation management, area inspection, out of specification investigation, logbook review etc.
- Trained new production staff members on safety and health guidelines and efficient production procedures with adherence to cGMP guidelines and proper machine operations.
- Collaborated with cross functional teams like Engineering, IPQA and QC to optimize production workflows.
Production Executive
Intas Biopharmaceuticals
Ahmedabad, India
12.2021 - 04.2023
- Independently Handled shifts with minimal supervision and executed manufacturing activities in cGMP compliant environment following relevant SOPs and maintaining appropriate documentation
- Reviewed raw data and maintained production trend forecasts to effectively plan batch execution
- Provided inputs into creation and maintenance of area SOPs and batch records
- Assisted colleagues in SOPs trainings, process execution and equipment operations
Production Executive
Biocon Biologics
Bangalore, India
09.2020 - 12.2021
- Worked as downstream production executive on monoclonal antibodies like Ustekinumab, Denosumab, Golimumab and Aflibercept
- Involved in preparation of quality documents like SOPs and checklists for production activities
- Supported Engineering, calibration, maintenance and qualification activities
- Maintained safe, cGXP compliant environment at all times
Production Executive
Reliance Life Sciences
Navi Mumbai, India
04.2018 - 08.2020
- Worked as downstream production Executive in mammalian cell culture suite on monoclonal antibodies like Bevacizumab, Trastuzumab, Denosumab, Adalimumab, Omalizumab etc and recombinant proteins like Erythropoietin, Follitropin and Interferon alpha and Beta
- Involved in Batch activities like CIP and SIP of equipment, Buffer preparation, Filter integrity testing and Area readiness for Audits
- Contributed to the achievement of key departmental activities including improving safety performance, reducing deviations and training compliance
Education
B.E. - Biotechnology
MGM's College of Engineering And Technology
Navi Mumbai Skills
- Downstream Processing
- Chromatography (Affinity, IEX, HIC, MMC, Size Exclusion)
- Tangential flow filtration
- Viral Filtration
- Bulk filtration
- cGMP, GXP
- QMS (Change control, Deviation)
- Softwares: SAP, LIMS, Unicorn, WinCC, DeltaV, Microsoft office
- SOPs , BPCR , Checklists, Protocols preparation
- Equipment Qualification
- Filter Integrity testing
Contact
A Type, 57-5, Sector-13, CIDCO Colony, New Panvel, MH, India 410206
Languages
English, Marathi, Hindi
Timeline
Asst. Manager
Kashiv Biosciences
12.2024 - Current
Senior Production Executive
Intas Biopharmaceuticals
04.2023 - 11.2024
Production Executive
Intas Biopharmaceuticals
12.2021 - 04.2023
Production Executive
Biocon Biologics
09.2020 - 12.2021
Production Executive
Reliance Life Sciences
04.2018 - 08.2020
B.E. - Biotechnology
MGM's College of Engineering And Technology
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