Enthusiastic and dedicated chemical engineer skilled in downstream processing, late-stage formulation, fill-finish, and continuous purification of biologics, with direct collaboration experience with Amgen, FDA, AbbVie, AstraZeneca, Biogen, Cytiva, Repligen, and others to advance the development of a continuous monoclonal antibody (mAb) platform aimed at making antibody-based vaccines affordable and accessible worldwide. Successfully developed and optimized multiple formulations for biological products while also serving as a regulatory consultant. Demonstrated leadership, time management, problem-solving, and personnel training expertise.
Overview
2
2
years of professional experience
Work History
Pharmaceutical Development Scientist, R&D
CinnaGen (Biopharma Company-Iran)
04.2018 - 02.2020
Analytical Method Development (AMD) Expert (6 months)
Developed and optimized analytical methods for analyzing and characterizing monoclonal antibodies (mAbs) and impurities, ensuring method specificity, sensitivity, linearity, and accuracy.
Utilized HPLC techniques, including Size Exclusion Chromatography (SEC), Protein-A affinity, Peptide Mapping, N-glycan analysis, Sialic Acid quantification, Ion Exchange Chromatography (IEX), Cation Exchange Chromatography (CEX) and Hydrophobic Interaction Chromatography (HIC) to characterize and quantify proteins and related impurities.
Formulation Development Scientist, (1.5 year)
Downstream processing and protein purification
Extensive hands-on experience in purification process development, characterization, and implementation in GMP facilities
In-depth knowledge of chromatography principles; experienced in AKTA systems and column operations
Broad understanding of downstream development and scale-up including centrifugation, normal flow filtration (NFF), tangential flow filtration (TFF), chromatography, virus inactivation, and virus removal
Responsible for technology transfer and scaling-up processes for liquid and lyophilized formulations of biopharmaceutical products.
Knowledge of formulation, filling, lyophilization, visual inspection, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling and the associated GMP/Device documentation and regulatory filings
Applied understanding of buffer effects on protein stability during ultrafiltration/diafiltration, informed by research highlighting the impact of specific buffers.
Leveraged techniques like dynamic light scattering (DLS), circular dichroism (CD) spectroscopy, and differential scanning calorimetry (DSC) to characterize protein conformation and stability in various buffer conditions to understand degradation pathways and assess their quality
Education
Ph.D. - Chemical Engineering
The Pennsylvania State University
University Park, PA
07-2025
M.Sc. - Chemical Engineering
University of Tehran
Tehran, Iran
01.2016
Awards
Women In Chemical (WIC) Engineering Award, AIChE, San Diego, Oct 2024, First-Place Presentation Award, MAST Meeting, Boulder, CO, Oct 2024, Iranian American Academics and Professionals (IAAP) Scholarship, United States, May 2024, Outstanding Organization Leader, Annual Student Organization Awards, Penn State University, April 2024, Innovative Program Award, Penn State University, April 2024, Student Leader Scholarship, Penn State University, December 2023
Publications & Conferences
Aylin Mohammadzadehmarandi, Andrew L. Zydney,” Effect of internal convection on protein transport through hollow fiber modules, ultrafiltration membranes and dialyzers”, (Paper in the progress).
Aylin Mohammadzadehmarandi, Andrew L. Zydney,” Critical Process Parameters for Achieving High Selectivity in Hollow Fiber Membrane Diffusion-Based Protein Transport”, (Paper in the progress).
Mirko Minervini, Aylin Mohammadzadehmarandi, Ali Behboudi, Sheldon F. Oppenheim, Andrew L. Zydney, “Integration of single pass tangential flow filtration and high-performance countercurrent membrane purification for continuous processing of monoclonal antibodies”, Biotechnology and Bioengineering, Feb. 2025. Doi: https://doi.org/10.1002/bit.29038
Aylin Mohammadzadehmarandi, Andrew L. Zydney, “Buffer effects on protein sieving losses in ultrafiltration and their relationship to biophysical properties”, Biotechnology Progress, May. 2024. Doi: https://doi.org/10.1002/btpr.3481
Aylin Mohammadzadehmarandi, Amy Determan, Christian Krumm, Lucas D. McIntosh, Andrew L. Zydney, “High-performance countercurrent membrane purification for host cell protein removal from monoclonal antibody products”, Biotechnology and Bioengineering, Aug. 2023. Doi: https://doi.org/10.1002/bit.28531
2024 AIChE Conference, San Diego- Buffer effect on mAb sieving losses during ultrafiltration and diafiltration processes.
2024 BPI (Bioprocess international) Conference, Boston- High Performance Counter-current Membrane Purification for Bioprocessing.
2024 MAST Conference Spring: NJIT- High Performance Counter-current Membrane Purification for Bioprocessing.
2023 MAST Conference Fall: Fayetteville, AR - Evaluating effective parameters on Monoclonal antibody sieving loss during ultrafiltration and diafiltration.
2023 American Chemical Society (ACS) Fall: Harnessing the Power of Data - San Francisco, CA - High-performance countercurrent membrane purification for host cell protein removal from monoclonal antibody products.
2023 MAST Conference Spring: State College, PA- Evaluating effective parameters on Monoclonal antibody sieving loss during ultrafiltration and diafiltration.
Training
Virtual Workshop, Penn State University | October 2024
Delivered a training session for industry professionals, including Pfizer scientists.