Dhanesh Savarkar

Microbiology professional with 10+ years of experience across industrial biotechnology, enzyme manufacturing and sterile injectable manufacturing. Experienced in microbiological quality control, upstream microbiology, fermentation support, environmental and pharmaceutical water monitoring, sterility testing, bacterial endotoxin testing (BET), growth promotion testing (GPT), media qualification and contamination control. Knowledgeable in GMP/GLP/GDP, data integrity, OOS/OOT investigations, deviations, root-cause analysis, CAPA, change control, audit readiness and laboratory documentation.

Works cross-functionally with Production, QC, QA, Engineering and R&D to support product quality, process reliability, compliance and continuous improvement. Seeking an Assistant Manager opportunity across QC and QA.

Microbiologist - Novozymes South Asia Pvt. Ltd. - Navi Mumbai, India

(2018-12)

• Manage upstream microbiology and fermentation activities supporting microbial and enzyme production, from seed preparation through production-scale fermentation.
• Perform microbiological analysis and routine monitoring of production cultures, seed trains, fermentation processes, raw materials, utilities and in-process samples.
• Support strain and seed-culture development, inoculum preparation, seed expansion and fermentation operations at laboratory and production scales.
• Monitor fermentation parameters and microbiological trends to identify process abnormalities, contamination risks and deviations at an early stage.
• Investigate contamination events, process deviations, abnormal fermentation profiles and yield variability using structured root-cause analysis and problem-solving methods.
• Collaborate with Production, QC, QA, Engineering and R&D to improve process robustness, product quality and manufacturing efficiency.
• Support GMP documentation, OOS/OOT investigations, CAPA, change control, deviation management and audit-readiness activities.
• Contribute to yield enhancement, process reliability, contamination prevention, operational efficiency and reduced manufacturing losses.
• Maintain microbial cultures in accordance with approved procedures and laboratory requirements.
• Coordinate microbiology laboratory consumable procurement, inventory monitoring and stock maintenance to support uninterrupted operations.
• Train and guide junior personnel in microbiological techniques, aseptic practices, sampling, process monitoring, SOP adherence and laboratory safety.

Microbiologist – Sterile Injectable Manufacturing - M.J. Biopharm Pvt. Ltd. - Taloja, Navi Mumbai

(2016-08 - 2018-12)

• Performed environmental monitoring to support microbiological control and sterile-manufacturing compliance.
• Conducted pharmaceutical water testing and microbial enumeration in accordance with approved procedures and applicable quality standards.
• Executed sterility testing, bacterial endotoxin testing (BET) and growth promotion testing (GPT), emphasizing accuracy, compliance and data integrity.
• Prepared, tested and qualified microbiological culture media according to established specifications and procedures.
• Supported sterility-assurance activities in sterile injectable manufacturing areas through routine monitoring and testing.
• Investigated and documented OOS/OOT results, deviations and laboratory incidents in accordance with approved procedures and quality systems.
• Supported instrument calibration, qualification and routine maintenance to ensure equipment remained fit for intended use.
• Maintained and reviewed analytical results, worksheets, logbooks, test records and laboratory documentation for accuracy, completeness and compliance.
• Maintained laboratory housekeeping and adherence to GMP, EHS, safety and contamination-control requirements.
• Participated in method verification, analytical method validation, method transfer and related technical activities.
• Supported laboratory documentation for internal, customer and regulatory audits.
• Applied relevant pharmacopoeial requirements, including IP, BP, USP and Ph. Eur., as applicable.

M.Sc. - Microbiology - K.B.P. College, University of Mumbai (2014-04 - 2016-06)

B.Sc. - General Microbiology - Smt. C.H.M. College, University of Mumbai (2011-03 - 2014-06)

H.S.C. - Maharashtra State Board (2010-04 - 2011-04)