Assay Development Ph D

Leila Jamalizadeh, Ph.D.

Beverly, Massachusetts, 01915 208-***-**** *.***************@*****.*** https://www.linkedin.com/in/leila-jamalizadeh Scientist Molecular Biology qPCR, Nucleic Acid Extraction Assay Development Ph.D.-trained molecular biologist with 2+ years of industry experience in PCR-based assay development and validation under GLP/ISO 13485 standards. Demonstrated expertise in nucleic acid extraction, qPCR, gene expression analysis, and protein/enzyme quantification. Skilled in designing and optimizing molecular assays from concept to validation, with strong attention to documentation and regulatory compliance. Known for adaptability, data accuracy, and contributing effectively to fast-paced, cross- functional teams.

Technical Skills

Molecular & Analytical Techniques:

PCR, RT-qPCR, nucleic acid/protein extraction, gel electrophoresis, enzyme activity assays, ELISA, LC- MS/MS

Assay Development, Validation & QC:

Method development, buffer optimization, LoD, linearity, specificity, precision, robustness, stability studies, quality control

Regulatory & Data Analysis:

GLP, ISO 13485, FDA compliance, SOP writing, QuantStudio™, JMP, Excel, Primer3, BLAST Professional Experience

QuidelOrtho, Beverly MA Scientist – Assay Development 06/2022 – 01/2025

(Position concluded due to company site closure)

Led the development of multiplex PCR assays for an automated IVD platform by supervising a team of four scientists, resulting in robust assay performance that supported FDA submission

Improved assay sensitivity 100-fold by refining target selection, redesigning the mastermix, and optimizing the thermocycler profile, enabling reliable performance for clinical validation

Engineered a custom in-house transport buffer to eliminate PCR inhibitors from complex clinical matrices, resulting in consistent amplification across diverse sample types and reducing assay failure rates

Validated qPCR assays by establishing LoD, linearity, specificity, and precision in accordance with ISO 13485 and GLP standards, enabling successful internal audits and regulatory progress

Collaborated cross-functionally with automation and hardware teams to align assay workflows with system requirements, reducing integration issues and improving platform reliability University of Idaho, Moscow, ID Research Assistant 01/2018 – 05/2022

Investigated a barley mutant exhibiting high mixed-linkage glucan (MLG) accumulation in grain to determine the molecular basis of this phenotype

Designed and conducted a comprehensive study integrating gene expression analysis (RT-qPCR), enzyme activity assays, and LC-MS/MS-based sugar metabolite profiling

Discovered that the mutation altered carbon flow in the glucan and starch biosynthesis pathways, uncovering a regulatory mechanism underlying MLG accumulation

Generated and presented research data that supported the selection of barley cultivars with tailored glucan content for brewing and food industry applications University of Idaho, Moscow, ID Teaching Assistant 01/2018 – 05/2018

Supervised and trained students in lab techniques and safety protocols

Prepared materials and assessed lab report to enhance student technical understanding Education

Ph.D. Plant Biochemistry University of Idaho, Moscow, ID 01/2018 – 05/2022

Focus: Molecular Biology, Gene Expression Analysis, Enzymatic Activity Assays

Dissertation: Biochemical Characterization of a Barley Mutant with High Mixed-Linkage Glucan Content

Professional Development

Mammalian Cell Culture & Biomanufacturing: (40-hour Hands-on Training, scheduled July 2025) Topics include aseptic techniques, cell thawing, passaging, and cryopreservation; bioreactor operation; transfection; cell harvest; antibody purification (AKTA Pure); and chromatography analysis (HPLC, UNICORN software)

Getting Started in 3D Cell Culture: Thermo Fisher Scientific (Certified February 2025) Drug Hunting: The Science of Making New Medicines Specialization: (6-course series), Coursera/Novartis (Certified April 2025)

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