Held position as board member in IAI (Indian Association in Iceland) for Women and Child Welfare within Iceland
VARDA KOLAPKAR
Scientist
Copenhagen
Summary
PROFILE
A technology and science-driven professional with 11 years of experience in formulation and drug product (DP) development of biosimilar products (mAbs, peptides) and novel biologics. Achieved significant advancements in formulation development, product characterization using formulation analytics and process development across various DP presentation formats (vials, PFS, cartridges, pen devices). Contributed to technology transfer documentation and regulatory dossier writing for DP 3.2.P section, while holding leadership roles.
Major achievements as an patent inventor:
- Composition comprising HER2 Antibody, Formulation and Process of Preparation Thereof; Patent Pub. no. 20250025410
- Low Dose IL-6 Formulations and Methods of Use Thereof; Patent Pub. no. 20260174834
Overview
1
1
Language
2026
2026
years of professional experience
Work History
Product Owner, Tech Transfer DP
FUJIFILM BIOTECHNOLOGIES
Denmark
2025 - 2026
- Conducted gap assessment, product CQA, product risk assessment, process design and description to enhance product development.
- Reviewed customer documentation for smooth tech transfer.
- Developed Engineering Run protocol and report; coordinated with manufacturing and MSAT team to ensure alignment.
- Prepare and maintain or give input to procedures for handling DP following cGMP.
- Led customer meetings, delivering technical inputs to address client needs and foster collaboration.
Team Leader, Drug Product Development
SANDOZ BIOLOGICS
France
08.2024 - 10.2025
- Established and developed a state-of-the-art formulation laboratory from scratch, recruiting skilled personnel and procuring premium equipment.
- Built and led a team encompassing all aspects of formulation development.
- Represented drug product development department as a Functional lead, interacting directly with client and within cross-functional teams.
- Designed and executed formulation development studies following quality system documentation.
- Coordinated staff capital resources and study planning independently.
- Served as a technical resource for formulation development of novel compounds.
- Delivered technical expertise in quality, manufacturing and process design, serving as subject matter expert for external clients and collaborators.
Senior Scientist Drug Product Development
ALVOTECH
Iceland
12.2022 - 06.2024
- Conducted stability studies (DS & DP) and biophysical characterizations that led to the development of robust manufacturing processes.
- Designed, performed, interpreted and reported process development studies, including filter, tubing, bag compatibility, mixing, and thermal cycling studies.
- Facilitated technology transfers from DP process development to DP manufacturing, ensuring smooth transition and compliance.
- Authored critical dossier sections for DP 3.2.P of CTD, enhancing regulatory submissions to the US-FDA and EMA.
- Developed comprehensive experimental study plans, protocols, and technical reports to support scientific rigor and regulatory compliance.
- Trained in Veeva Vault for quality system documentation and regulatory dossier authoring and submissions.
Scientist, Drug Product Development
ENZENE BIOSCIENCES LTD.
India
11.2018 - 11.2022
- Managed end-to-end DP projects within a small team, ensuring timely delivery.
- Spearheaded formulation screening and product development, resulting in the successful filing of 2 patents.
- Formulated novel liquid and lyophilized formulations and executed seamless technology transfers to production sites.
- Developed analytical screening strategies using Differential Scanning Calorimetry (DSC) and Dynamic Light Scattering (DLS) techniques to accelerate and ensure optimal formulation screening.
- Designed, executed, interpreted, and documented complex process studies, including hold-time, incompatibility (filters, tubing, bags), freeze-thaw, in-use stability, thermal excursion, photostability, and lyophilization.
- Prepared technology transfer packages and provided on-site monitoring support as the R&D Functional Lead at cGMP manufacturing sites.
- Authored and compiled technical documentation for Indian and global (EMA, US-FDA) regulatory submissions, facilitating successful approvals.
- Conducted stability assessments to determine shelf life for biosimilars.
- Supervised and mentored a team of trainees, delivering hands-on technical training on advanced DP development techniques.
- Authored and compiled comprehensive technical documentation for Indian and global (EMA, US-FDA) regulatory submissions.
- Designed DP user manuals and administration leaflets to ensure precise dosage preparation guidelines for clinical use.
Research Associate, Formulation development Team
LUPIN BIOTECH LTD.
India
09.2015 - 11.2018
- Spearheaded the method development and protein characterization for 3 distinct biosimilar products using advanced characterization techniques like SEC-MALS, MFI, DLS and DSC.
- Spearheaded the method development and protein characterization for 3 distinct biosimilar products using advanced characterization techniques like SEC-MALS, MFI, DLS and DSC.
- Executed comprehensive subvisible particle testing following USP and USP compendia standards by advanced flow imaging techniques like MFI and archimedes.
- Directed the department's sample management system.
- Drafted and cross-reviewed SOPs, protocols, and reports to maintain compliance and standardization within the department.
- Instrument learned: SEC-MALS, Microflow Imaging (MFI), DLS, nano DSC, USP particle counter, Archimedes, Viscometer, densitometer, glide force measurement, UV Spectrophotometer, Osmometer, pH meter.
Education
Masters of Technology - Biotechnology
VELLORE INSTITUTE OF TECHNOLOGY
India2015
Bachelor of Technology - Biotechnology
D.Y. PATIL COLLEGE OF BIOTECHNOLOGY & BIOINFORMATICS
India2013
Skills
- Formulation (early and late stage) and process development
- Formulation analytics- Unagi, Microflow Imaging (MFI), Differential Scanning Calorimetry (DSC), Dynamic Light Scattering (DLS), via Freeze, SoloVPE, Ultrafiltration diafiltration (UFDF), Viscometer, Densitometer
- NIF, Biosimilars, Novel biologics
- Process characterization and robustness studies- mixing, contact material compatibility (filter, tubing, bag), hold time, freeze thaw, pH and excipient ranging
- Dossier writing DP 32P section for US-FDA, EMA
- Quality system documentation- study plans, protocols, reports, SOPs
- Veeva Vault, ICH guidelines
- Cross-functional leadership
- Integrity, Compassion, Resilience, Team spirit, Continuous development
Interests
Accomplished long distance sea swimming tournaments and been state level swimmer representing India
Timeline
Team Leader, Drug Product Development
SANDOZ BIOLOGICS
08.2024 - 10.2025
Senior Scientist Drug Product Development
ALVOTECH
12.2022 - 06.2024
Scientist, Drug Product Development
ENZENE BIOSCIENCES LTD.
11.2018 - 11.2022
Research Associate, Formulation development Team
LUPIN BIOTECH LTD.
09.2015 - 11.2018
Product Owner, Tech Transfer DP
FUJIFILM BIOTECHNOLOGIES
2025 - 2026
Masters of Technology - Biotechnology
VELLORE INSTITUTE OF TECHNOLOGY
Bachelor of Technology - Biotechnology
D.Y. PATIL COLLEGE OF BIOTECHNOLOGY & BIOINFORMATICS