Sukonya Bhattacharjee

About Sukonya Bhattacharjee

Having amassed over a year of professional experience in the biopharmaceutical industry, I hold impressive credentials as a biotechnology specialist that is synonymous with research and analytical assays. My work at Enzene Biosciences Ltd has made me proficient at method validation, quality control, project management, and contributing towards developing state-of-the-art solutions in the biologics industry.I have gained experience with HPLC and its many forms- CEX, SEC and RP-HPLC. In addition, I also have expertise with spectrophotometry and LPC. Some of the remarkable work I engaged in includes testing and optimizing protein based solutions, which in turn aided in cancer vaccine development during my time working for RnD and QC departments.I am engaged in the preparation of biosimilarity assessment reports supporting regulatory submissions to the European Medicines Agency (EMA). In this role, I apply my scientific expertise to the development of regulatory documentation for biological medicinal products, ensuring compliance with EMA biosimilar guidelines and relevant EU regulatory frameworks. I contribute to the preparation of scientifically robust biosimilarity reports that support demonstration of comparability in terms of quality, safety, and efficacy for approval within the European Union.In addition to my technical responsibilities, I am actively involved in proposal development, preparing detailed scientific rationales and technical documentation related to biosimilar development programs. This includes drafting clear, regulatory-compliant proposals for clients that define the scope of work, study strategies, timelines, and deliverables in alignment with EMA expectations. I collaborate closely with subject matter experts, project management, and business development teams to ensure that proposals address both regulatory requirements and client-specific objectives.A key aspect of my current role involves cross-functional collaboration with multidisciplinary teams to ensure that all regulatory documentation is scientifically sound, internally consistent, and aligned with client expectations. My ability to interpret complex analytical and scientific data and translate it into clear, structured regulatory narratives enables effective support of ongoing biosimilar projects and constructive engagement with clients and regulatory stakeholders.

Experience

1. Research Associate

   Enzene Biosciences Ltd

   Jul 2025 — Present · Pune, IN

Education

• South Point High School, Kolkata

  10th Boards

• KIIT School of Biotechnology

  B. Tech and M. Tech dual degree, Biotechnology

  2019 — 2024

• Nava Nalanda

  12th Boards