Derakhshandeh (Doki) Dezfuly

** ******* **, **********, ** 01545

Cell: 847-***-****

Email: adxu1y@r.postjobfree.com

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SUMMARY

• Chemist with 24 years of pharma experience in biologics development and microbial fermentation; 5 years of hospital clinical experience. Possess strong technical skills, providing analytical testing and manufacturing support to various products and third party manufacturing (TPM) projects.

• Extensive scale-up and lab experience of chromatography and filtration unit operations. Evaluate downstream purification process technologies.

• Troubleshoot process-related issues for early- and late- stage products (Phase I to Commercial)

• Support recovery & purification of biologics/ proteins from cell culture, and natural products from fermentation under cGMP/cGLP guidelines.

• Hard working with dedication, self-motivation and a quick learner with critical thinking. Handle multiple tasks and assignments. Team player and focus on deliverables. PROFESSIONAL EXPERIENCE

Scientist II, Protein Analytics, Science & Technology, Operations, AbbVie Bioresearch Center, Worcester, MA 01/2019-present

• Provided analytical testing and TECAN liquid handling for late-phase products and the control chart tracking for commercial products.

• Main scientist contributed significantly analyzing over 3000 samples for biological products.

• Used Excel macro and Chemstation applications to process analytical data and increased assay throughput, delivered the results accurately and efficiently.

• Trouble-shot instrument issues; ensured accurate reporting of testing results for better efficiency.

• Effectively resolved ELN issues in linking data with result summaries. Scientist I, Technical Operations, Downstream Group Abbvie Bioresearch Center, Worcester, MA 01/2013-12/2018

• Developed a high-throughput method using PreDictor plate and evaluated its application to purify protein A eluate samples with limited material for understanding of acid species (ARs) formation.

• Performed DOE studies to evaluate the effect of pH, temperature, sugar, salts, amino acid and vitamins on formation of extracellular ARs and variability correlation with minimum material.

• Conducted a lab scale Vmax study to determine filter capacity and size estimation.

• Supported multiple projects including commercial biologic next generation, TPM contract projects, cell culture and analytical support simultaneously.

• Improved lab operation by working with the vendor to trouble shoot AKTA Pilot and assembled components for IT to work on software maintenance.

• Supported an immunological-therapeutic product, completed charge variant assays and data analyses of over thousands of samples to support process development, process characterization, comparability, scale-up studies, GMP, PPQ and post-PPQ campaigns per schedule. Associate Scientist II, Manufacturing Sciences, Downstream Group Abbott Bioresearch Center, Worcester, MA 01/2010-12/2012

• Designed and performed experimental plans to evaluate product quality improvement at a capture process step using three protein A resins (Fractogel, Nuvia and HS). Developed salt gradient Derakhshandeh (Doki) Dezfuly

61 Lebeaux DR, Shrewsbury, MA 01545

Cell: 847-***-****

Email: adxu1y@r.postjobfree.com

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methods and successfully reduced acidic species and enriched lysines, resulting in achieving a group goal of four invention disclosures.

• Characterized and quantified aggregate profiles of clarified harvest produced by hydrolysates vs. chemical-defined media (CDM) via SEC assay, and examined sources of aggregates and impurities.

• Performed process optimization studies for anti-TNF mAb high concentration process development.

• Generated source materials of clarified harvest and Protein A eluate at lab and pilot scales to support 2nd generation downstream process development for an anti-TNF monoclonal antibody (mAb).

• Performed feasibility study and demonstrated use of simulated moving bed (SMB) as a capture step for antibody purification platform process development.

• Performed harvest acidification of various pipeline products, evaluated dynamic binding capacity of capture resins for yield improvement, and analyzed residual protein A and host-cell proteins (HCP) in process streams for quality improvement.

• Initiated and supported execution of 300L-scale runs to demonstrate process capability in chemical- defined media and protein A purification to reduce acidic species by 3% for greater improvement.

• Performed analytical testing of incoming cell lines and supported cell bank qualification process for internal and TPM cell culture operations.

Research Associate II, Technical Operations, Downstream Group Abbott Bioresearch Center, Worcester, MA 10/2005-12/2009

• Performed bench- and pilot-scale process scale-up studies to determine effects of improvements on downstream process steps and final drug substance

• Performed Protein A purification of cell culture harvest, analyzed oligosaccharide species and charge variants in support of anti-TNF mAb high titer cell culture process

• Evaluated UF/DF operation to support a high concentration process for an anti-TNF mAb.

• Evaluated pH range studies and contributed to robustness and efficiency of 2nd generation process.

• Performed DOE and contributed to yield improvement at hydrophobic interaction chromatography

(HIC) for mAb ambient temperature process development.

• Contributed to commercial manufacturing process robustness by improving greater HCP clearance.

• Evaluated closed processing system and various filter membranes to determine the best clarification filter by studying parameters such as volume and pressure.

• Supported manufacturing execution of Engineering and PV runs for TPM projects.

• Performed process mapping for mAb engineering and PV runs performed at CDMO. Process Support & Development Scientist, Biologics Technical Operations, Specialty Products Division, Abbott Laboratories, North Chicago, IL 1999 to 2005

• Performed process validation and justification studies to meet FDA requirements.

• Supported three internal commercial products and external TPM operations.

• Supported urokinase isolation and purification to achieve quality and compliance

• Supported initial assessment and experimental design for determination of ion exchange chromatography ability to remove human serum albumin impurity at operational extremes.

• Designed and troubleshot a rouge experiment for urokinase and r-UK potency assay.

• Supported temperature effect study on urokinase production.

• Isolated an enzyme protein from fed-batch and perfusion harvests and performed comparability studies.

• Tech transferred purification processes of an enzyme product from TPM client to Abbott

• Initiated range finding, assessed and optimized strong anion exchange chromatography capture step. Derakhshandeh (Doki) Dezfuly

61 Lebeaux DR, Shrewsbury, MA 01545

Cell: 847-***-****

Email: adxu1y@r.postjobfree.com

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• Troubleshot capture step for process change from perfusion to fed-batch cell culture and trained cell culture personnel in HPLC method.

• Performed testing of incoming urokinase cell lines and support mammalian cell line qualification process. Associate Scientist, Fermentation Development R&D, Specialty Products Division Abbott Laboratories, North Chicago, IL 1997 to 1999

• Improved recovery processes for a series of fermentation-based antibiotics.

• Supported scale-up and recovery process implementation for commercial products

• Troubleshot manufacturing activities and provided process support for Amonoethoxyvinylglycin

(AVG), cyclosporine and glycol-peptide antibiotic using analyses for metabolites and pH

• Performed process validation and justification on macrolide antibiotic using Lab MAX reactor. R&D Chemist (Manpower), Cardiac Team, Abbott Diagnostics Division, Abbott Laboratories, Abbott Park, IL 1995 to 1997

• Performed various IMX, TDX and Axsym assays: rate matching, calibration curve, linear dilutions, stability tests, and specification studies.

• Performed Axsym reagent kit stability.

• Provided product support including troubleshooting of diagnostic test kits.

• Re-launched several products in clinical phase.

• Performed NAPA/PROC dropper bottle equivalency study on Axsym. Laboratory Technician

Central DuPage Hospital, Winfield, IL 1990 to 1995

• Blood Chemistry, Urinalysis, and EKG, Phlebotomy.

• Supervised, trained and mentored technicians, and medical students. TECHNICAL SKILLS

Protein purification process operations: cell lysis, centrifugation, preparative column chromatography, fraction collection, depth filtration, ultra-filtration/ diafiltration (UF/DF)-TFF, aseptic microbiological and cell culture techniques, dialysis, filter sterilization, sonication and sterile technique. Gel filtration, scale-down steps, viral clearance, clearance (impurity, endotoxin, HMW species, etc.), hold time and process justification

Chromatography and method development: Ion exchange, Affinity, Hydrophobic Interaction Chromatography HIC, Size-exclusion Chromatography (SEC), HPLC (normal and reverse phase). Equipment & Instruments: AKTA (Explorer, Pilot, Cross-Flow models), Shimadzu, Hewlett Packard, Agilent. GE Cross-Flow, Millipore M12, Pall Minim

Analytical assays: TECAN-SSP, TECAN N/D, SEC, CEX/ WCX-10, ELISA, Protease Activity Assay, CE-SDS, SDS-PAGE, Immunoblotting, Southern Blotting, Lowry and Bradford Assay, β-Glucan, Poros A, DNA, Oligosaccharide, Insulin assay, ELISA, Enzyme Assays, Impurity Assays (Protein A, HCP, antifoam C, Poloxamer, Methotrexate) and other product quality assays Others: microscopy, osmolarity, spectroscopy (plate reader, UV-Vis, fluorescence), thin layer chromatography. Computer skills for data analysis and reports: Microsoft Word, Excel, PowerPoint, instrument operating systems (e.g. Unicorn, Empower), Electronic Laboratory Notebook (ELN), SAP and sample management systems (LIMS).

Derakhshandeh (Doki) Dezfuly

61 Lebeaux DR, Shrewsbury, MA 01545

Cell: 847-***-****

Email: adxu1y@r.postjobfree.com

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EDUCATION

Bachelor of Science, Chemistry, Northeastern Illinois University, Chicago, IL 1993 SELECTED AWARDS

• Excellence Award for Accomplishment of CMC2.150.HIC PPQ campaign – 2020

• Recipient for Plant of the Year Excellence Award All for One AbbVie – 2019

• Silver Award Global Pharmaceutical Operations for outstanding performance on and lasting contribution to TPM process Validation – 2015

• Gold Award for outstanding performance in supporting TPM antibody drug conjugate product – 2013

• Silver Award for outstanding performance for development of simulated moving bed for tech transfer – 2009, for monoclonal antibody capture – 2011.

• Gold Award Global Pharmaceutical Operations for outstanding performance and lasting contribution on CDMO tech transfer– 2009

SELECTED PRESENTATIONS and REPORTS

1. D. Dezfuly, “Dynamic Binding Capacity Studies of three chromatography resins (Mabselect, MabSelect Sure and Prosep Ultra Plus) for three molecules” presented at Abbvie Bioresearch Center Process Research symposium 2015.

2. D. Dezfuly, “Next Gen Capture Process aligned with the platform approach” 2012. 3. D. Dezfuly, et al “Feasibility Study of Continuous Chromatography on Monoclonal Antibody Capture Processes” poster, Process Research symposium, Abbott Bioresearch Center 2011. 4. S-M. Lau, D. Dezfuly, et al “The Effect of Harvest Acidification on HCP Clearance by Protein A Chromatography” poster, Process Research symposium, Abbott Bioresearch Center 2011. 5. S-M. Lau, D. Dezfuly “Protein A Resin Dynamic Binding Capacity Study with Hydrolysate and Chemically-Defined Media”, 2011.

6. D. Dezfuly, Report “HCP Reduction Control Strategy for the anti-TNF mAb Campaign”, 2011. 7. D. Dezfuly, Report “Clearance of Cell Culture Components by Downstream Process in Process Validation Campaign” 2010

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