Sandeep K.
Postdoctoral Researcher
Experience
Apr 2024 - Present
1 year 9 monthsJena, Germany
Postdoctoral Researcher
Friedrich Schiller University
- Established and optimized viral detection assays (SARS-CoV-2, IAV) in A549 and Vero cell lines, using qPCR, immunofluorescence and AFM-based morphology analysis to generate quantitative data on viral protein expression and particle quality.
- Characterized protein aggregation and fibril formation using NanoFTIR, fluorescence spectroscopy, Raman and ThT assays, linking biophysical signatures to stability and quality attributes of protein formulations.
- Applied statistics-based data analysis to evaluate assay robustness and variability, supporting QbD-oriented discussions on method performance and critical analytical parameters.
- Led method development and data interpretation for analytical workflows, collaborating with cross-functional colleagues and training team members on advanced biophysical instrumentation.
Sep 2020 - Mar 2024
3 years 7 monthsJena, Germany
Scientific Assistant (PhD Scholar)
University Hospital Jena
- Designed and executed robustness studies for cell-based ion channel assays by systematically varying key parameters (cell density, incubation time, cRNA concentration), defining design space and acceptable operating ranges, resulting in comprehensive SOP documentation and enhanced assay reliability.
- Led product characterization and screening of small molecules, RNA, and DNA targeting CNG ion channels using HPLC, UV-Vis, fluorescence spectroscopy, and DLS, generating integrated datasets on purity, aggregation, and functional activity that informed critical quality attribute (CQA) evaluations.
- Developed and optimized analytical protocols for RNA and protein quality and stability by implementing rigorous validation steps, supporting preclinical drug development and ensuring accurate assessment of product-related quality attributes.
Jul 2017 - Feb 2020
2 years 8 monthsUnited States
Research Assistant
University of Iowa
- Developed, synthesized and optimized nanoparticle-based drug formulations, using electrophoretic methods, DLS and SLS to characterize particle size, charge and stability, and subsequently optimized formulations for lyophilization for in vivo mouse studies in cystic fibrosis.
- Designed and evaluated the stability of ubiquinol/gamma-cyclodextrin formulations using Turbiscan, ROS and MTS assays, flow cytometry and DLS, linking analytical results to formulation performance and product quality.
Jul 2016 - Jun 2017
1 yearIndia
Deputy Manager
Development Alternatives
- Managed a microbiology lab in a cGMP manufacturing environment, implementing safety protocols and SOPs for pilot testing of a rapid bacterial detection kit, ensuring compliant documentation and contributing to method validation reports.
- Performed material characterization (XRD, PSD, ITC) to define key material properties, feeding analytical results into risk assessments and formulation decisions for industrial applications.
May 2015 - Aug 2015
4 monthsPune, India
Research Intern
National Chemical Laboratory, Pune
- Conducted a multi-spectroscopic investigation integrating IR, UV-Vis, ¹³C NMR and molecular dynamics simulations to quantify interactions between BSA and testosterone (protein-ligand interactions).
Apr 2015 - Apr 2016
1 year 1 monthRourkela, India
Master Thesis Student
National Institute of Technology, Rourkela
- Characterized protein-ligand (Lysozyme and Rhodamine B) interactions using biophysical techniques (UV-Vis, fluorescence, CD, molecular docking) to characterize changes in secondary structures.
Summary
Scientist with 6+ years’ experience in analytical development and process characterization for biologics and complex formulations, including robustness studies, product characterization and method validation. Hands-on background with chromatographic and spectroscopic methods (HPLC, UV-Vis, fluorescence, DLS, ITC, AFM) and biological assays (ELISA, Nanoluciferase, cell-based assays). Practical exposure to Quality-by-Design concepts and risk-based thinking, now aiming to contribute as a Product Expert / Analytical Process Manager, driving CQA evaluation and QbD-based analytical strategies in biopharmaceutical projects.
Languages
English
AdvancedHindi
AdvancedOriya
AdvancedBengali
IntermediateGerman
IntermediateEducation
Oct 2020 - Jun 2026
University Hospital Jena
PhD in Molecular Medicine · Molecular Medicine · Jena, Germany
Oct 2011 - May 2016
National Institute of Technology, Rourkela
Integrated Master of Science in Chemistry · Chemistry · Rourkela, India · 7.8/10
Certifications & licenses
Certification In GMP
GMP Academy
Project Management
Friedrich Schiller University
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