Ankit Kumar
Downstream processing Expert
Pune,MH
Summary
Accomplished Downstream processing professional with 13+ years of experience in biologics and biosimilars development, scale-up, technology transfer, viral clearance and regulatory submissions. Lead cross functional teams, manage multiple development programs, and deliver robust, scalable and regulatory compliant manufacturing processes, Currently Seeking a leadership opportunity for carrier advancement and to drive innovation, implement advanced technologies, and contribute strategically to organizational growth and commercial success.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Senior Manager
Gennova Biopharmaceuticals
Pune, Maharashtra
08.2025 - Current
- Lead end-to-end downstream process development for monoclonal antibodies, biosimilars, and recombinant proteins.
- Design and optimize purification processes including Affinity, CEX, AEX, HIC, MMC, viral inactivation, depth filtration, SPTFF, and UF/DF.
- Drive DoE/QbD-based process characterization for yield improvement, aggregate reduction, charge variant control, impurity clearance, viral clearance, and robustness studies.
- Lead scale-up from laboratory to pilot and commercial manufacturing scale, ensuring successful technology transfer to manufacturing team.
- Provide manufacturing support for process validation, cleaning validation, buffer preparation, and in-process hold time validation.
- Troubleshoot manufacturing process issues to ensure product quality and operational efficiency.
- Review and approve study protocols, development reports, BMRs, technology transfer documents (TTDs).
- Lead deviation investigations, root cause analysis, and CAPA implementation.
- Manage project timelines, budgets, and resource allocation.
- Mentor and develop team members, fostering technical growth and performance excellence.
- Analyze and interpretation of experimental data for process improvement.
- Support laboratory operations including equipment maintenance and calibration compliance.
Manager
Gennova Biopharmaceuticals
Pune, Maharashtra
07.2021 - 07.2025
- Supported process validation, cleaning validation and hold time validation during tech transfer.
- Authoring and reviewing documents for technology transfer, scale down protocols, and reports and SOPs.
- Drafting and reviewing CMC documents required for the application submission for product market approval.
- Involved in the planning and execution of various lab scale studies for process improvements.
- Planning and execution of on-site viral clearance and validation study for mAb projects.
- Design and qualification of scale down model to support investigational studies and for viral clearance study and process characterization study.
- Resin re-usability studies to estimate effective recycling of various affinity chromatography resins.
- Technology transfer of developed process to manufacturing.
- Preparation of essential documentation including project summary, process development reports (PDRs), feasibility studies, and Material Safety Data Sheets (MSDS).
- Maintained communication with stakeholders, offering regular updates on project progress and milestones.
- Conducted comprehensive risk analyses for development and transfer initiatives, implementing proactive mitigation strategies.
- Prepared site feasibility documentation and gap identifying documents for seamless transitions to manufacturing.
- Contributed to patent writing documentation efforts, safeguarding intellectual property and fostering innovation.
- Responsible for maintaining QA-related tasks in alignment with DSP lab requirements, including updating SOPs, URS, IQ, OQ, and validation reports.
Assistant Manager
Gennova Biopharmaceuticals
Pune, Maharashtra
08.2018 - 07.2021
- Planning and execution of pilot scale consistency batches and tox batch supply.
- Perform and lead lab-based DSP experiments employing Chromatography and TFF.
- Design, develop and execute experiments in downstream purification within project timelines.
- To mentor junior staff/trainees conducting laboratory experiments.
- Molecule to manufacturing for improved recovery, product quality and COGs reduction.
- Process characterization using DoE approach for a robust process, creating design space and risk assessment for CPPs.
- Design and execute DoE-based process optimization studies.
- Develop purification strategies including capture, intermediate purification, and polishing steps.
- Optimize critical process parameters (pH, conductivity, loading, flow rate).
- Interpret analytical data and recommend process improvements.
- Develop scale-down models for pilot and manufacturing scale.
- Prepare process development reports and regulatory documents (IND/BLA modules support).
- Participate in risk assessments (FMEA) and process characterization studies.
- Support technology transfer to manufacturing sites.
- Troubleshoot purification challenges (aggregation, charge variants, HCP clearance).
- Coordinate with analytical, upstream, and QA teams.
Research Associate/Senior Executive
Gennova Biopharmaceuticals
Pune, Maharashtra
07.2012 - 07.2018
- Execute lab-scale purification processes including Protein A, IEX, HIC, MMC, UF/DF.
- Perform chromatography runs using AKTA systems and TFF systems.
- Prepare stocks, working buffers, and process CIP solutions.
- Conduct in-process sampling and coordinate analytical testing (SEC, CEX, SDS-PAGE, etc.).
- Maintain batch records, experimental notebooks, and documentation.
- Assist in process optimization and scale-down model development.
- Support technology transfer documentation.
- Ensure GMP compliance and maintain lab safety standards.
- Maintain equipment calibration and preventive maintenance records.
- Support deviation investigations and QA audits.
Industrial trainee (BITP Program, DBT, Government of India)
Intas biopharmaceuticals Ltd.
Ahmedabad
01.2011 - 08.2011
- Purified CHO-derived therapeutic proteins using multi-step chromatography.
- Performed monoclonal antibody purification using Protein A chromatography.
Education
M.Sc. - Biotechnology
Vinayaka Mission's Research Foundation - University
01.2009
Post Graduate Diploma - Biotechnology (Tissue Culture Technology)
Board of Technical Education, Uttar Pradesh (BTEUP)
01.2007
B.Sc. - (Chemistry, Botany and Zoology)
University of Lucknow
01.2005
Intermediate - Science
Uttar Pradesh State Board of High School and Intermediate Education (UPMSP)
01.2000
High School - Science
Uttar Pradesh State Board of High School and Intermediate Education (UPMSP)
01.1998
Skills
- Downstream Process development (mAbs, Biosimilars)
- Affinity Chromatography
- CEX
- AEX
- HIC
- Mixed mode Chromatography
- Single pass TFF
- UF/DF
- Viral inactivation
- Viral clearance and validation studies
- Technology transfer and scale up
- Scale down qualification
- Process characterization
- QbD
- DoE
- Statistical optimization
- GMP Manufacturing Support
- CPV
- SPC Monitoring
- Deviation Investigation
- OOS Investigation
- OOT Investigation
- CAPA
- Planning
- Monitoring
- Document drafting
- Document review
- Team leadership
- Project management
Certification
- Professional Diploma in Clinical Research (PDCR)
- Managing Project Stakeholders
Accomplishments
- Successfully transferred multiple monoclonal antibodies and biosimilars from process development to 50L perfusion manufacturing scale for clinical and commercial production.
- Co-inventor on international patent: WO/2016/063299 – Novel purification process for recombinant Tenecteplase (TNK-TPA).
- Received EQUITY Award for process innovation reducing harvest volume and improving scalability.
- Contributed to timely completion of cGMP technical documentation in collaboration with CMC and global partners.
- Led viral clearance validation programs supporting regulatory filings.
Patents And Publications
- WO/2016/063299 - A novel purification process for isolation and commercial production of recombinant TNK-TPA (Tenecteplase).
- Development of a process for large scale production of PfRH5 in E. coli expression system. https://doi.org/10.1016/j.ijbiomac
- HRI, a stress response eIF2α kinase, exhibits structural and functional stability at high temperature and alkaline conditions. https://doi.org/10.1016/j.ijbiomac
Personal Information
Title: Senior Manager- Downstream Process Development (Biologics & Biosimilars)
Timeline
Senior Manager
Gennova Biopharmaceuticals
08.2025 - Current
Manager
Gennova Biopharmaceuticals
07.2021 - 07.2025
Assistant Manager
Gennova Biopharmaceuticals
08.2018 - 07.2021
Research Associate/Senior Executive
Gennova Biopharmaceuticals
07.2012 - 07.2018
Industrial trainee (BITP Program, DBT, Government of India)
Intas biopharmaceuticals Ltd.
01.2011 - 08.2011
M.Sc. - Biotechnology
Vinayaka Mission's Research Foundation - University
Post Graduate Diploma - Biotechnology (Tissue Culture Technology)
Board of Technical Education, Uttar Pradesh (BTEUP)
B.Sc. - (Chemistry, Botany and Zoology)
University of Lucknow
Intermediate - Science
Uttar Pradesh State Board of High School and Intermediate Education (UPMSP)
High School - Science
Uttar Pradesh State Board of High School and Intermediate Education (UPMSP)