K R NANDA KUMAR
Reykjavik
Summary
Dedicated bioprocess professional with over a decade of expertise in upstream manufacturing of biosimilars, demonstrating proven skills in GMP documentation and quality management systems. Proficient in aseptic techniques, fed-batch, perfusion, and batch processes, as well as media-feed preparation and harvest operations . Experienced with both single-use and stainless steel bioreactors, consistently recognized for effective project prioritization and management. Eager to leverage extensive experience as a quick learner and adaptable team player to contribute meaningfully to dynamic teams.
Overview
10
10
years of professional experience
Work History
USP Team Lead
Alvotech
Iceland
11.2025 - Current
- Act as Shift Team Lead, managing day-to-day USP manufacturing activities, task prioritization, and real-time decision-making during GMP operations.
- Execute aseptic mammalian cell culture from vial thaw to production in single-use bioreactors (Wave 20/50, SUB 500–2KL) under fed-batch and (1KL) perfusion modes.
- Serve as SME for perfusion bioreactors with ATF systems, supporting stable long-term cultures and troubleshooting complex process deviations.
- Lead floor-level troubleshooting for pH/DO excursions, sensor calibration issues, pressure alarms, filter integrity failures, and automation communication faults.
- Ensure continuous inspection readiness of USP suites through proactive oversight of equipment, documentation, and GMP compliance.
- Lead and support deviation investigations, impact assessments, root cause analysis, CAPAs and QA notifications, ensuring timely and compliant closure.
- Author, review, and approve SOPs, MBRs, and technical protocols in alignment with cGMP standards.
- Work extensively with DeltaV automation, supporting recipe execution, alarm response and control strategies.
- Collaborate closely with MSAT, Process Engineering, Automation, and QA for investigations, data trending, and process improvements.
- Support engineering runs, technical studies, and validation activities.
- Mentor and train new team members, strengthening technical capability and GMP culture within the shift team.
- Drive continuous improvement initiatives to enhance process robustness and operational efficiency.
Senior Biotechnologist
Alvotech
Reykjavik, Iceland
11.2022 - 10.2025
- Ensure strict adherence to cGMP and EHS practices, consistently conducting all activities in a compliant and safe manner.
- Execute the aseptic culturing of mammalian cells, managing the process from cell revival in shake flasks to completion in single-use bioreactors-fed batch and perfusion, following established protocols.
- Expertly manage and troubleshoot single-use bioreactors Wave-20/50, and SUB 500,2KL alongside 1KL Perfusion bioreactor systems with ATF optimizing upstream cell culture manufacturing for monoclonal antibody production.
- Work closely with MSAT and Process Engineering teams to share process observations, support data collection, and assist in process-related investigations.
- Mentor and coach new team members to foster a multi-skilled and engaged USP team environment.
Assistant Manager Upstream Operations-Manufacturing
BIOCON BIOLOGICS INDIA LTD
Bengaluru, India
09.2016 - 10.2022
- Expertly managed and troubleshooted state-of-the-art single-use bioreactors (RM-20/50, RM-100/200, and HYLONE SUB-500) alongside fully automated 2KL Bioreactor systems optimizing upstream cell culture manufacturing for monoclonal antibody production.
- Conducted thorough contamination investigations, identifying root causes efficiently and effectively within stipulated timelines.
- Proficient in SAP transactions, driving operational excellence and streamlining processes through extensive process and operational improvements.
- Leveraged software expertise in WinCC, PCS, Rockwell, and ABB, enhancing operational control and monitoring.
- Actively trained and supported teams in manufacturing operations, fostering a culture of continuous improvement and collaboration.
- Innovated sterile media filtration processes, maintaining sterility while streamlining operations.
- Skilled in handling advanced instruments and equipment, including Blood Gas analyzers, Osmometer, YSI-2950 analyzers, CEDEX Bio, NTU Meters, Continuous Centrifuges, pH meters, Bio welders TC, Bio sealers, and Autoclaves.
Education
MSc - Biochemistry
CMS College of Science and Commerce, Bharathiyar University
Coimbatore, India01-2016
BSc - Biochemistry
Sree Narayana Guru College, Bharathiyar University
Coimbatore, India01-2014
Skills
- Experience in CHO mammalian cell culture
- Fed-Batch & Perfusion Processes
- Proficient in single-use bioreactors
- Proficient in ATF-based perfusion
- DeltaV operational modes expertise
- WinCC / PCS / Rockwell / ABB
- Alarm Handling & Process Interlocks
- cGMP & Data Integrity (EU-GMP)
- Deviations, Impact Assessment & RCA
- CAPA Implementation
- SOP / BMR Authoring & Review
- Inspection & Audit Readiness
- Shift Team Leadership
- On-the-Floor Decision Making
- Training & Mentoring
- Cross-Functional Collaboration
LANGUAGES
English
Malayalam
Hindi
Tamil
Timeline
USP Team Lead
Alvotech
11.2025 - Current
Senior Biotechnologist
Alvotech
11.2022 - 10.2025
Assistant Manager Upstream Operations-Manufacturing
BIOCON BIOLOGICS INDIA LTD
09.2016 - 10.2022
BSc - Biochemistry
Sree Narayana Guru College, Bharathiyar University
MSc - Biochemistry
CMS College of Science and Commerce, Bharathiyar University