Naresh G
Bangalore
Summary
Recognized professional with over 12 years of experience in the biopharmaceutical industry, with strong expertise in downstream process development, commercial manufacturing, and antibody–dye conjugation. Currently working as a Manufacturing Scientist II at Beckman Coulter Life Sciences (Danaher), Bangalore, leading New Product Introduction (NPI), Design transfers/Tech transfers and validations, and design control documentation. Proven success in delivering projects such as Supernova and CellMek on time through effective execution of design validation protocols, PFMEA, supply chain planning, technology transfer, and process optimization.
Skilled in Visual Project Management (VPM), iObeya, and Miro Board for project tracking, mapping, and cross-functional collaboration. Experienced in PSP (Problem solving process) and LBR (Lean Batch Record) preparation, supporting lean and compliant operations. Recognized for enabling on-time product delivery by combining innovative approaches with established practices, while contributing to efficient process design, scale-up, and troubleshooting. A detail-oriented, adaptable leader and communicator with strong interpersonal and problem-solving abilities, thriving in fast-paced environments and open to national and international opportunities.
Overview
13
13
years of professional experience
3
3
Languages
Work History
Manufacturing Scientist II
Beckman Coulter Lifesciences - Danaher Company
03.2024 - Current
- Lead manufacturing and validation activities for antibody–dye conjugates used in flow cytometry, as part of New Product Introduction (NPI) and technology transfer programs.
- Operate and validate AKTA Pure 150 chromatography systems, performing process qualification runs, system suitability checks, and ensuring data integrity and alignment with validation master plans.
- Actively participate in design control processes, including updating User Needs, Design Inputs, Design Outputs, Design Traceability Matrix, and Design Transfer documents for new product and labelling designs.
- Conduct and maintain Process Failure Mode and Effects Analysis (PFMEA) and update supply chain planning documents to align manufacturing readiness with design validation outcomes.
- Develop and execute Design Validation Protocols for dry product label integration (CellMek Phase 2 project), qualifying barcode label materials (LM74680 and BW0074) for long-term compatibility with polystyrene and polypropylene substrates.
- Perform detailed root cause investigations using structured methodologies (Pitchfork Analysis, 5 Whys) to evaluate conjugation performance, reduction efficiency, purification, and storage conditions.
- Utilize Visual Project Management (VPM) for project tracking, milestone planning, and deliverable monitoring, ensuring clear communication and transparency across cross-functional teams.
- Experienced in iObeya and Miro Board tools for project mapping, risk visualization, and workflow coordination with R&D, QA, and supply chain functions.
- Contribute to PSP (Production System Practices) and LBR (Lean Batch Record) preparation and review to drive lean manufacturing documentation and ensure data accuracy in electronic systems.
- Implement continuous improvement initiatives including 5S for label folder organization, SOP revisions for label templates, and optimization of conjugation and purification workflows.
- Collaborate across QA, R&D, and Manufacturing to ensure SOP compliance, readiness for Design Transfer, and adherence to regulatory expectations and Danaher Business System (DBS) principles.
Deputy Manager
Biocon Biologics
04.2022 - Current
- Company Overview: Biocon is an innovation led fully integrated biopharmaceutical company that develops affordable biosimilars, generic formulations & complex APIs
- Lead and manage a team of downstream process engineers and technicians to ensure efficient execution of biopharmaceutical manufacturing operations.
- Collaborate with cross-functional teams to transfer and scale-up manufacturing processes from development to commercial production.
- Ensure compliance with regulatory guidelines, including FDA and cGMP requirements.
- Monitor process performance through data analysis and implement corrective actions as necessary.
- Manage equipment and facility upgrades to support manufacturing process improvements.
- Expertise in Manufacturing and Process development, covering various aspects such as Process/Scale-up, Gap Assessment, Process Risk Assessment (FMEA), Single Use manufacturing, BMR, MFR, Cleaning Validation, Process Validation (PV)Protocols, Equipment Qualifications in eVLMS, Operational Cost Reduction, and SAP.
- Experience building coalitions with troubleshooting of downstream operations, mainly in chromatography and UFDF stage, as well as centrifugation, VF, and Depth filtration.
- Skilled in handling Quality Management System which includes change control, deviations, Investigation, Root Cause Analysis, Troubleshooting, and CAPA in Track wise.
- Hands-on experience on production scale cGMP downstream operations including CIP, chromatography, Virus filtration, Tangential flow filtration, Filling and freeze thaw as well as equipment cleaning/sanitization, solution prep, and filter integrity testing.
- Expertise in preparation of facility and equipment related risk assessment by using FMEA tool.
- Develop and implement process improvement initiatives to enhance productivity, yield, and product quality.
Assistant Manager
Biocon Biologics
06.2020 - 04.2022
- Company Overview: Biocon is an innovation led fully integrated biopharmaceutical company that develops affordable biosimilars, generic formulations & complex APIs
- Provided leadership to a team of 10 Associates in all aspects of large-scale Downstream operations i.e. Clarification Purification Filtration and TFF operations; with the use of Depth filtration skid, chromatography systems, VF skid, and UF/DF system, via automation systems (i.e. WinCC, Unicorn, and ABB) and supporting business systems (i.e. SAP, Trackwise and eVLMS).
- Oversee purification activities (CIP, Clarification, Chromatography, Viral Filtration UF/DF, product pH adjustment, filtration, and Formulation)
- Ensure adherence to safety, cGMPs, and SOPs through auditing tools, on-floor coaching, pre-job discussions, and actively working with my directs.
- Perform troubleshooting and problem resolution of on-floor process issues in collaboration with PD and QA to keep daily schedules on track.
- Manage the development of manufacturing associates and the team through individual succession plans, continued feedback sessions, personnel calibrations/evaluations, and providing new development opportunities.
- Implementing innovative technical solutions appropriate for the downstream
- Demonstrating ability to manage human and material resources towards the achievement of stated objectives, to plan and manage work, motivate and provide effective guidance to a team of professional and support staff.
- Planning and scheduling of the downstream operations such as column packing, filtration and chromatography stages.
- Technical support of downstream operations (Chromatography, Nano filtration and UFDF operations) for troubleshooting and investigations.
- Maintaining a high level of productivity in the manufacturing plant to deliver
Sr. Executive
Hetero Biopharma
04.2018 - 06.2020
- Company Overview: Hetero Biopharma is part of Hetero Drugs which develops and manufactures affordable monoclonal antibodies and therapeutics
- Commercial production, specifically the purification of MAB, by means of operating different types of chromatography columns, in addition to operating UF/DF skids for both ultrafiltration and diafiltration by means of tangential filtration (TFF).
- Successfully executed Trial batches, validation batches, and commercial batches of Rituximab, Bevacizumab, Trastuzumab, and Adalimumab.
- Involve in the Preparation of facility and documents for Audits and self-inspection. Initiation of deviations , Change controls and involved in investigations.
Production Executive
Bharat Biotech
09.2012 - 04.2018
- Company Overview: Bharat Biotech is a pioneering biotechnology company known for its world-class R&D and manufacturing capabilities. Their mission is to deliver affordable, safe and high-quality vaccines and bio-therapeutics that help people prevail over diseases
- Handling of Downstream activities like Purification, TFF, Bulk Filtration, and the Inactivation of Vero cell-based Rabies and Japanese encephalitis vaccine production.
- Preparation and Review of Standard Operating Procedures (SOPs) and Batch Manufacturing Records (BMRs)
- Initiation and closure of QMS documentation like Incidents, Deviations, and Change Controls.
- Preparation and Review of Summary Lot Protocols (SLPs), Training the Operators regularly for effective implementation of QMS. Review of BMRs and submission to QA
Education
Masters - Biochemistry
Sri Venkateswara University
06.2012
Batchelder of Degree - Biochemistry
Sri Venkateswara University
06.2010
Skills
Quality Management systems
Interests
Reading Books
AWARDS
Go-Getter Award For excellent performance and accomplishment in manufacturing, GMP compliance
Aaward For Good manufacturing compliance in Manufacturing
Timeline
Manufacturing Scientist II
Beckman Coulter Lifesciences - Danaher Company
03.2024 - Current
Deputy Manager
Biocon Biologics
04.2022 - Current
Assistant Manager
Biocon Biologics
06.2020 - 04.2022
Sr. Executive
Hetero Biopharma
04.2018 - 06.2020
Production Executive
Bharat Biotech
09.2012 - 04.2018
Batchelder of Degree - Biochemistry
Sri Venkateswara University
Masters - Biochemistry
Sri Venkateswara University
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