The Potential of AI in mAb Downstream Processing
Unlocking hybrid mechanistic-neural modeling, real-time peak cutting, and digital twins in biomanufacturing.
Professional Summary
Biotechnologist with 6+ years of experience across GMP-regulated biopharmaceutical and pharmaceutical manufacturing, spanning upstream operations, downstream protein purification, process validation, quality assurance, and chemical API production. Hands-on expertise in multistep chromatography on ÄKTA and NOVASEP systems, viral inactivation and filtration, TFF/diafiltration, and specialized chemistry including PEGylation and reductive amination. Experienced across mammalian, insect, and bacterial expression systems, with direct contribution to large-scale viral vaccine manufacturing. Strong foundation in cGMP, EU GMP, ICH Q7, Annex 1, and Annex 15, with proven cross-functional coordination, documentation, and training capabilities. WES-certified BSc in Biotechnology; working toward CAPM certification in near future.
Professional Experience
API Production Technician
Eurofins CDMO Alphora Inc. | Mississauga, ON, Canada
Dec 2023 – May 2026
- Executed GMP-compliant chemical API manufacturing across 5 production suites and approximately 15 product types, handling batch scales from 5 L (kilolab) to 400 L (pilot plant) per Batch Production Records (BPRs) and cGMP standards, on a continental rotating shift schedule.
- Operated and monitored a wide range of processing equipment including glass-lined reactors, centrifuges, vacuum dryers, mills, filtration units, and HPLC systems; performed unit operations such as weighing, charging, mixing, crystallization, filtration, drying, milling, and packaging.
- Handled Class 2 organic solvents (e.g., THF), strong acids and bases, and high-potency intermediates using full PPE up to Level P7 (Tyvek suit with supplied air, full-face respirator); prepared scrubbers and executed safe chemical storage, handling, and disposal of API residues with proper waste labeling and segregation.
- Performed routine equipment calibration, preventive maintenance, and CIP procedures; troubleshot in-line equipment issues including HPLC pump disassembly, inspection, priming, and de-airing to minimize downtime and maintain production continuity.
- Conducted in-process sampling, coordinated sample submission to QC, and executed batch reconciliation calculations with graphical comparison to historical batches; maintained batch timing data to support cycle-time analysis and warehouse reporting.
- Participated in recurring internal and external quality audits, including FDA and Japanese international inspections, maintaining inspection-ready documentation with full HSE and GDP compliance.
- Participated in Root Cause Analysis (RCA) meetings for deviations and near-misses, contributing preventive recommendations; proposed BPR and SOP content improvements where discrepancies between documented and executed procedures were identified.
- Acted as co-lead in the supervisor's absence, overseeing daily production activities, prioritizing tasks, and coordinating workflow across shifts; coordinated daily with Tech Transfer, QA, QC, maintenance, planning, and warehouse teams; trained and onboarded new staff on procedures, equipment operation, GMP requirements, ethics, and workplace safety standards.
- Maintained strict 5S housekeeping standards and supported continuous improvement initiatives.
Quality Assurance Specialist – Process Validation
CinnaGen Biosimilar Company | Tehran, Iran
Mar 2023 – Jul 2023
- Supported the preparation and execution of Process Validation Protocols (PVPs) and Validation Reports (PVRs) for new and existing biopharmaceutical manufacturing processes, in alignment with Annex 15 and EU GMP requirements.
- Supported and executed Cleaning Validation studies, including swab/rinse sampling design, MACO calculations, recovery studies, clean/dirty hold-time studies, and risk-based documentation in line with Annex 1 requirements.
- Reviewed and supported Equipment Qualification (IQ/OQ/PQ) protocols; applied risk-based methodologies (FMEA) to prioritize critical process parameters and validation activities.
- Contributed to a vial optimization project evaluating gliding force and breaking force of injectable vials, supporting product quality and process improvement.
- Provided in-process QA oversight during aseptic filling operations, monitoring Grade A/B cleanroom environment compliance and adherence to Annex 1 requirements.
- Revised and maintained SOPs and controlled documents through annual review cycles; supported investigations of process deviations, OOS/OOT events, CAPA implementation, and disposition of non-conforming materials.
Downstream Purification Specialist – R&D
CinnaGen Biosimilar Company | Karaj, Iran
Aug 2021 – Mar 2023
- Executed downstream purification workflows for the adalimumab biosimilar across multistep chromatography (Protein A affinity, IEX, SEC, HIC) on ÄKTA systems, following established R&D protocols and supporting process development objectives.
- Prepared buffers and culture media per defined recipes; documented detailed observations and method notes (e.g., dissolution behavior, timing deviations) to support iterative protocol refinement by the development team.
- Executed TFF, depth filtration, and nanofiltration experiments as designed by the development team; recorded process data and reported results for downstream analysis.
- Performed CIP and COP of equipment, column packing and qualification (plate height, asymmetry theoretical plate evaluation), and resin handling.
- Served as cross-functional liaison between R&D, Production, QC, QA, Tech Transfer, and Warehouse departments; conducted routine site visits to production areas to support technical alignment and process transfer.
- Prepared technical reports and PowerPoint presentations summarizing experimental work and outcomes; trained production staff on purification procedures, equipment operation, and underlying biology and chemistry principles.
Downstream Purification Technologist – Production
CinnaGen Biosimilar Company | Karaj, Iran
Oct 2019 – Aug 2021
- Executed GMP-compliant downstream purification for a broad portfolio of recombinant proteins and monoclonal antibodies, including adalimumab, eculizumab, interferon β-1a, human growth hormone, Liraglutide (GLP-1 analog), and PEG-filgrastim, in BSL-2/3 cleanroom environments.
- Contributed to the large-scale manufacturing of over 1 million doses of the SPIKOGEN® COVID-19 vaccine, produced using insect cell (Sf9) expression and viral vector technology, maintaining uninterrupted output under tight timelines and regulatory oversight.
- Performed chemical modification chemistry for PEG-filgrastim production, including cyanoborohydride-mediated reductive amination, reaction quenching, and downstream purification of the conjugated product.
- Contributed to Liraglutide production using preparative HPLC-based purification and lyophilization processes.
- Processed E. coli fermentation batches through cell disruption using high-pressure homogenizers, followed by inclusion body isolation, solubilization, and refolding prior to chromatographic purification.
- Prepared inoculum through seed culture, stepwise scale-up, and cell counting / viability checks across mammalian, insect, and bacterial systems; supported upstream operations across bioreactor scales from 5 L to 4500 L, including cell culture and harvest.
- Operated disc-stack centrifuges for clarification of mammalian cell culture and E. coli harvest; performed depth filtration to reduce bioburden and turbidity ahead of column loading.
- Ran multistep chromatography purification trains (Protein A affinity, IEX, SEC, HIC) on ÄKTA Pilot/Process and NOVASEP HPLC systems per validated SOPs; documented all runs in UNICORN software with real-time in-process testing (pH, conductivity, UV absorbance).
- Performed viral inactivation (low-pH hold) and operated viral filtration (nanofiltration) steps as part of validated mAb purification trains, following time-point sampling and hold confirmation protocols.
- Executed UF/DF operations using TFF cassette systems for protein concentration and diafiltration-based buffer exchange; documented operational parameters and volume reductions in strict adherence to batch records.
- Performed CIP/SIP procedures, packed and qualified chromatography columns, and managed resin storage, sanitization, and lifetime tracking; prepared buffers and media at production scale using calibrated equipment.
- Conducted final filtration and bulk preparation of drug substance per validated SOPs; performed yield and mass balance calculations and QC sample collection.
- Collected environmental monitoring samples (viable/non-viable particles, surface contact plates) and documented all activities in BPRs and SCADA/iFIX systems; troubleshot production-scale equipment and trained new production staff.
Earlier Experience
Microbiology Laboratory Intern
Shahid Madani Hospital | Karaj, Iran
Oct 2018 – Sep 2019
- Completed a clinical laboratory internship across microbiology, biochemistry, hematology, and sample reception departments.
- Worked in the reception department, collecting and processing incoming specimens including labeling, routing, and preparation for analysis across laboratory sections.
- Performed phlebotomy on adult and pediatric patients; supported CBC/FBC analysis in the hematology department.
- Supported the biochemistry section with routine blood chemistry panel analysis using automated laboratory analyzers.
- Performed urine analysis and processed urine cultures; conducted antibiogram testing to assess antimicrobial susceptibility.
- Prepared and handled diverse culture media (blood agar, EMB, MacConkey, Sabouraud, thioglycolate broth) under sterile conditions; performed sample plating and streaking.
- Conducted Gram staining and microscopic examination for organism identification, including bacteria and molds; performed differential testing across various sample types.
Biotechnology Laboratory Apprentice
Amol University of Special Modern Technologies | Amol, Iran
2018 – 2019
- Supported academic research projects under faculty and graduate student supervision, applying core molecular biology and cell culture techniques.
- Performed plant tissue culture and subculturing, including work with African violet (Saintpaulia ionantha), under sterile conditions.
- Conducted PCR, SDS-PAGE, and agarose gel electrophoresis for DNA and protein analysis of plant samples.
- Assisted in nucleic acid extraction, DNA sequencing preparation, and gene expression assays on plant cell material.
- Operated laboratory equipment including centrifuges, microscopes, and gel documentation systems; maintained lab records in compliance with biosafety protocols.
Technical Skills & Systems
Chromatography & Purification
ÄKTA Pure/Pilot/Process (UNICORN), NOVASEP HPLC, Protein A affinity, IEX, SEC, HIC; preparative HPLC; resin screening, column packing and qualification.
Filtration & Concentration
TFF/UF-DF, depth filtration, viral filtration (nanofiltration), final filtration.
Specialized Bioprocessing
Viral inactivation, viral vaccine manufacturing (Sf9/viral vector), PEGylation, cyanoborohydride-mediated reductive amination, lyophilization, inclusion body processing (solubilization & refolding).
Upstream & Cell Platforms
Mammalian (CHO, HEK) cell culture; insect cell (Sf9); E. coli fermentation; inoculum preparation, seed culture, cell counting, harvest; bioreactor scales 5 L – 4500 L.
Manufacturing & Equipment
Disc-stack centrifuges, high-pressure homogenizers, glass-lined reactors, vacuum dryers, mills, filtration skids, CIP/SIP and COP systems, TFF cassette systems.
Chemical Processing
API manufacturing, crystallization, distillation, solvent recovery, Class 2 solvent handling (THF), high-potency intermediate handling, scrubber preparation.
Quality & Validation
Process Validation (PVP/PVR), Cleaning Validation (MACO, recovery studies, hold-time), Equipment Qualification (IQ/OQ/PQ) review, FMEA, deviation/CAPA, change control, non-conformance management, ALCOA+ data integrity.
Compliance & Documentation
EU GMP, ICH Q7, cGMP, GDP, Annex 1, Annex 15, BPRs, SOPs, technical reports, environmental monitoring, batch reconciliation.
Analytical & Software
In-process testing (pH, conductivity, UV/Vis), SDS-PAGE, yield/mass balance. Software: UNICORN, LIMS, SCADA/iFIX, Minitab.
Education
Bachelor of Science in Biotechnology
University of Amol, Iran | WES Certified
2015 – 2019
Certifications
BioReady™ Certified
Process Development Technician
Issued by BioTalent Canada (2026)
View Certificate- GMP Certificate
- WHMIS 2015
- Working toward CAPM (Certified Associate in Project Management), targeted 2027
Languages
English (fluent)
Persian (native)
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