Quality Assurance Control

Kamy Missaghi

“Delivers Successful Results”

************@*******.*** 860-***-****

QA Validation Specialist

Summary

Technically skilled Scientist with extensive experience in biopharmaceutical re- search and drug discovery covering multiple disease areas including Oncology and CNS research. Expertise in target validation, assay development, GMP and biologi- cal mechanism of action studies, contributing to hit-to-lead optimization. Core Competencies

• Expertise in Molecular Biology • IVD, ELISA, BCA, Binding assays

• Quality assurance and quality control • Western/Southern Blotting, qPCR

• Analysis of drug targets in protein therapeutics • Clone screening, Isotyping, FACS

• Protein purification and expression • In vitro diagnostics – Biomarkers For- mulation and emulsion experience • GLP/GMP. ISO and SOP guideline

• Development of Protocols and Experiments • Verification / Validation Immunoassays

• Working with Certificates of compliance • Pre-Clinical / Clinical Trials specialist

• Mammalian Cell culture –Electrophoresis • Technology transfer – Design control

• Identification and validation of targets • Human and Mouse assays

• Cell line development, cell line development • Real time Stability and Release study

• DNA and RNA assay development-Vaccine research • FDA submission / 510(K), ISO, GRP

• Multiplex bead array, MSD and B- and T-cell assays • Antibody based assays – Sequencing Soft Skills

• Deliver Results, Problem solver • Adaptability, Meet deadlines

• Dependable, Thorough, Ethical • Honest, Team player, Organized

• Lead Teams, Self-directed, Proactive • Always strive to improve Key Accomplishments

• Delivered double-digit gains in product quality

• Leading development on >100 products from concept to commercialization

• Creative thinking skills to challenge current understanding and help define process improvement and optimization opportunities

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Professional Experience

SERAPLEX BIOLOGICALS, Quality Assurance / Product Development Manager

• Developed, implemented and coordinated product assurance programs to set standards to ensure quality of delivery products.

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• Directed and coordinated quality inspection of supplies and vendors, and surveillance of suppliers quality assurance processes.

• Coordinated activities of Quality control personnel in order to control quality of product and to ensure compliance with legal standards.

• Assisted in the development of new product lines based on experience as well as provided the end users with product and technical support.

• Assisted with business development proposals and wrote quality assurance policies and procedures.

• Developed and analyzed data and product specification to determine present standards and establish proposed quality standards as well as inspection and testing materials, facilities, and products.

TAKEDA PHARMA. Sr Analytical Chemist (Contractor- Azzur Group) Since 10/21

Develop, qualify and implement analytical methods to support stability and various formulation development studies.

As a QA Validation Specialist I have hands-on experience with Process Validation/Process Performance Qualification, Sterile Injectables, Media-fills (Strategy, Protocol Review)

Review/approval of validation protocols and reports but not limited to steam sterilization, environmental monitoring, clean utilities, process equipment, temperature mappings, cleaning validation, and process validation.

Mentored and trained staff, and other resources as needed. as well as able to guide the validation team for developing applicable validation documentation.

• Write and review technical documents supporting analytical development and regulatory filings, including analytical method procedures (SOPs) and method development reports.

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• participate in general lab instrument maintenance and perform trouble shooting indepen- dently.

• Many years of experience in small and large Pharmaceutical Company.

• Working knowledge of cGMP requirements on validation methods and principals includ- ing ISPE, GAMP guidelines, and FDA, CFR Part 11 Electronic Records and Signatures requirements.

• Evaluate, interpret, and present data at group meetings.

• Bring in new ideas from the literature or external practices and propose alternative ap- proaches.

• Maintain accurate and complete laboratory record. Method and instrument validation.

• Provide training to junior analysts.

• Collaborate with other team members.

• Executed assays in Mixed mode/multi-modal chromatography (Hydroxyapatite) and UV Spectrophotometry (Protein Concentration).

• Developed IOQ, QP, QAV, SDCS, and SOP for SOLO VPE Spectrometer, Dionex ICS-6000 with different detectors and Waters HPLC.

• Validate analytical equipment, software and the process used in QC and Validation de- partment.

ATARA BIO. Sr. Quality Control Associate (Contractor) 2021 to 2021

• Supported manufacturing and technical operations by executing QC analytical as- says for product release with emphasis in cell-based bioassays.

• Performed testing on final product clinical and commercial lots.

• Draft and review laboratory SOPs, test methods, technical documents.

• Supports troubleshooting, investigations, technical reports, and protocol writing/ revision. Vector design and construction to clonal cell line.

• Designs and executes assays to evaluate target-specific T cell characteristics and function.

• Performs mammalian cell culture and production of recombinant transient and sta- ble mammalian cell lines.

• Experience with Immune cell-based assays including proliferation and cytotoxicity.

• Experience in data verification, Batch analysis, Instability and problem solving.

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• Supported the qualification of a GMP compliant QC bioanalytical laboratory.

• Experience in cGMP cell therapy manufacturing and testing facility.

• Knowledge of relevant regulations and FDA guidance.

• Assist with ongoing continuous improvement of LMS (CW).

• Performed Osmolality test of liquid sample materials or final products in quality control environment. Developed mammalian Cell lines.

• Highly organized, detail oriented and able to manage multiple projects.

• Performed Bacteria Endotoxin Test (BET) for the determination of bacterial endo- toxin in a sample using Endosafe.

• Experience in cell-based bioassay and cell culture UTAK LABORATORY. Lead Chemist/ Manager of Quality Control 2019 to 2020

• Responsible for all technical and operational activities within the QC Laboratory

• Overseas the execution of testing including routine analysis, stability and testing, technology transfer and analytical methodology.

• I have demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.

• Lead implementation of new analytical methods at QC, including qualification, transfer, and validation strategies.

• Product Classification, Classified UTAK products to ensure the correct product claim.

• Improved engineering and chemical process to create a efficient flow into manu- facturing.

• Train and execute analytical methods associated to method qualification, transfers and/or validations.

• Reviews and assess proposed changes to assays and/or QC equipment via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status.

• Resolved all; customers product performance complaints and technical questions related to product and instruments.

• Provider technical expertise/guidance to lab staff and within cross-function.

• Managed Daily operation, planning, critical reagent, equipment's and materials.

• Lead product development for new products and validation process.

• Analyzed and reported risk analysis on product development.

• Designed and improved new techniques for UTAK products.

• Process and interpret chromatographic, LC data to problem solve.

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• Design and replace new products and methods to improve and correct the current results.

• Owns and reviewed controlled documents, standards, methods, and protocols.

• Taking steps to bring UTAK in compliance with GLP and GMP as well as FDA visits.

• Ensured the Lab operations comply with applicable regulations, and we were ready for any internal or external audits or inspections.

• Responded and resolved all customer technical problems.

• Developed new ELISA method and filtration technique to accelerate and make the production more efficient.

• Created new formulation process to improve the production process Amgen Process Development. Sr. Associate (Contractor) 2018-2019

• Executed and documented Biophysical characterization analysis e.g., DLS, HIAC, MFI. Samples include cell culture supernatant, drug substance, drug product in sup- port of lead candidate selection, process development, process characterization, stabil- ity, and manufacturing comparability.

• Conducted cell-based assays for protein drug safety evaluation.

• Performed isolation, culture, immune assay of human PBMC.

• Participated early-stage molecular assessment activity.

• Operated automation instrument.

• Executed experiments in aseptic processes such as formulation, filtration, fill, stopper- ing, lyophilization and visual inspection.

• Conducted the study of aggregation for formulated protein drug product caused by Process Engineering. Developed mammalian Cell lines. Research and Development Associate Agensys Pharma (Contractor) 2017-2018

• Performed assay testing in the Hybridoma group using flow cytometry (multiplex cells (FACS), and beads), ELISA, Octet, and Luminex platform.

• Experience in assay transfer and qualification/validation; T-cell related experience is preferred. Vector design and construction to clonal cell line.

• Supports assay optimization, qualification, and validation

• Able to use IntelliCyt iQue, Accuri C6/HTFC, Luminex, Octet, and TECAN robotics and Hudson Crane systems.

• Tested Primary and secondary Clone Screening as well as bleed samples.

• Performed Isotyping and Quantitative testing using Luminex and Octet instruments.

• Skilled in MS office applications, FlowJo, and GraphPad.

• Participate in the evaluation of new and high-throughput technologies.

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• Experience with antibodies and antibody-drug conjugates (ADC)

• Knowledge of cGMP and regulatory compliance in biotechnology product develop- ment

• Summarize and report analytical results.

• Achieves goals consistently and completes work effectively and efficiently. Quality Control Scientist Kite Pharma (Contractor) 2016-2017

• Established specifications and testing process of raw materials

• Assay development and qualification of cell-based assay

• Experience with immunoassay technologies such as, standard ELISA, MSD, and Lu- minex

• Detail-oriented with strong organizational and record keeping skills.

• Assist with ongoing continuous improvement of LMS.

• Plays supporting role in developing T-Cell killing assays and other assays for cell therapy product release and characterization.

• Supports assay optimization, qualification, and validation

• Experience writing and following Standard Operating Procedures (SOPs)

• Monitor and trend data and working collaboratively with cell culture manufacturing

• Performed various analytical bioassay

• Develop, revise and review SOPs, qualification/validation protocols and reports

• Address and managed deviations related to analytical procedures

• Select, install, and troubleshoot instruments devices Scientist Kerrington Corporation 2015-2016

• Designed and performed ELISA Immunoassays, qPCR and HPLC assays for new startup companies.

• Designs protocols established quality assurance standards and optimized assays.

• Interpreted, executed, and coordinated overall project assignments.

• Developed Human and Mouse assays as well as Verification and Validation Immunoas- says.

• Providing hands on assistant in Real time Stability and Release study as well as FDA submission, 510(K), ISO and GRP.

• Development of Protocols and Experiments.

• Design Specifications and Change Controls.

• Prepare Installation, Operation, and Performance Qualification Protocols.

• Generate Lifecycle documents: URS, FS, DS documents for QC Laboratory equipment/ instruments.

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Quest Diagnostics –Aerotek (Contractor) 2014-2015

Biomarker Clinical Trial Test Development Scientist II

• Investigated new technologies and testing systems for the Clinical Trials Laboratory.

• Determined methods and procedures on new assignments and provided guidance to labo- ratory personnel.

• Interpreted, executed, and coordinated overall project assignments.

• Performed complex or novel assignments requiring development of new or improved techniques and procedures.

• Interacted with technical departments and vendors to obtain validation samples, reagents, and instrumentation to achieve results.

• Generated, analyzed, and summarized data for test validation packages.

• Prepared Standard Operations Procedures (SOP’s) for new assays.

• Prepare Quality Control and Preventive Maintenance manuals for new test systems.

• Coordinated technical transfer of new procedures to appropriate department. Private consultant for a Startup company, Los Angeles, CA (Contractor) 2011-2014

• Designed, developed, and performed protein characterization and Immunoassays for new product and improved current product performance.

• Designed and conducted ELISA experiments and interpreted data.

• Development, qualification/validation of immunoassays in support of Preclinical and clinical studies in accordance with current GLP/GMP guidelines.

• Prepare documentations for FDA submission / 510(K). SIEMENS Healthcare Diagnostics, Los Angeles, CA 2007-2010 Scientist – Biochemist

• Specialized in validation of newly developed immunoassays from verification phase to full scale manufacturing phase by utilizing knowledge, experience, analytical statistic, inter-department communication and teamwork skills

• Extensive hands-on experience with staff and project management, interacting with mul- ti-functional groups to achieve business objectives. Successful in moving projects to market launch and managing for consistent high-quality outcomes. Strong organizational skills with excellent understanding of QA/RA processes as they related to the manufac- ture and support of IVD products.

• Responsible for liquid validation, method transfer and validation of reagents as well as hands on support to protocol design, documentation, validation, and execution of process cleaning validation process.

• Designed and conducted experiments and interpreted data to resolve product problems or to improve current product performance that meets or exceeds customers' needs.

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• Responsible for validating new and improved immunoassays to ensure that assay perfor- mance will address customer requirements.

• Responsible for development, qualification/validation of immunoassays in support of Preclinical and clinical studies in accordance with current guidelines and industry stan- dards for such assays. Create and prepare regulatory documents for domestic and in- ternational labeling.

• Implemented and validated multiple analytical methods to aid in the development and commercialization of automated diagnostics and biomarker assays

• Reviews and revises standard operating procedures (SOP) for technical accuracy and compliance with regulatory requirements.

• Ability to work in cross-functional teams on multiple projects simultaneously

• Designed, developed real time Stability study for assay components

• Designed Validation protocols for method comparison, Imprecision, reference range stud- ies in accordance with current guidelines and industry standards for such assays Ionian Technology Inc., Research Scientist, Upland, CA 2006-2007

• Development and optimization of assays for infectious disease organisms

• Design and performed DNA and RNA assays

• Develop and optimize the assays for Biothreat organism stimulants as well as background reduction for the department of defense and homeland security.

• Experience in product-oriented, infectious disease diagnostics development, and performance of nucleic acid amplification techniques

• Experience with Real time PCR, qPCR

• Extensive experience in HPLC, LC/MS-TOF / GC instrumentation for bio analytical analysis

• Basic maintenance preparing solvents and troubleshooting of LC/MS-TOF, HPLC instrument.

• Generating quantitative and qualitative data of small oligonucleotide candidates in support of DARPA grant studies.

• Conduct analytical analysis with LC-MS, HPLC / GC by extraction of samples, chromatographic and spectroscopic. Cedars-Sinai Medical Center Research Institute

Prostate Cancer Center Department of Drug development Research Associate II 2005-2006

• Clinical and Pre-clinical drug development.

• Developed BCA Assay to determine total protein in sample.

• Transformation and Transfection.

• Developed, performed, and analyzed assays using RAW and HEP 3B Cells for various projects using ELISA.

• Developed, performed, and analyzed Hypoxia assays.

• Coordinate the activities associated with the evaluation, initiation, and management of Clinical Development clinical trials.

• Protein Purification

• PSA and B2M ELISA

• Dose Response

• Immunodepletion of B2-Microglobulin

• Development of new prostate cancer marker

• Cell culture, ProteinChip SELDI

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Memorial Sloan Kettering Cancer Center. New York, N.Y. Department of Gene Transfer and Somatic Cell Engineering Research Associate 2003-2005

• Molecular biology (like PCR, real-time PCR, Cloning, Mutagenesis, Chimeras).

• Preparation of plasmid DNA and packaging cell lines.

• Phase I clinical trials and vaccine production under cGMP

• Writing and revising SOPs.

• Performed studies of new drug candidates, e.g., Solubility, stability, and excipient com- patibility.

• Coordinate the preparation of Monitor Workshops and Investigator Meetings

• Immunology, Biochemistry (bioassays, protein assays, affinity purification).Cell Biology

(transfections, transductions).Gene Transfer, Gene Expression, and vector Design.Clini- cal productions-Under GMP environment (vaccines, Cell Banks).

• Tissue Culture- Maintenance of cell lines growing as suspension culture or as monolayer, Transfection, Transduction, qPCR.

• Production of Clinical Human and Murine Tyrosinase plasmid under cGMP.Cell Biology- Immunofluorescence, Immunoperoxidase, FACS

• Making Master cell banks under cGMP

• Performing QA/QC tests for stability and release of DNA vaccines.

• Generation of producer cell lines for clinical production of dendritic cells expressing ty- rosinase genes.

• Development and characterization of mouse Monoclonal antibodies to leukemic cells.

• Injecting, bleeding, dissecting mouse for different studies. Curagen Pharmaceutical - Senior Research Scientist 1998-2003

• Managed the group of six people in the Gene Isolation, data analysis and SNPCalling group.

• Independently performed a full range of tasks for assigned research project.

• Coordinate the activities associated with the evaluation, initiation and management of Clinical Development clinical trials

• Designed R&D projects and methods using HPLC.

• Designed DNA primers, and other reagents for production.

• Troubleshooting and operating HPLC and TLC instrumentation and data acquisition.

• Participated in the selection of Single Nucleotide Polymorphism (SNP).

• Provided training in SOPs, GCPs, and Good Regulatory Practices (GRP).

• Applied genetic and molecular biology methods towards identifying single-nucleotide polymorphisms.

• Identification, validation, and high put screening of disease related targets.

• Performed studies of new drug candidates, e.g., Solubility, stability, and excipient com- patibility.

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• Determined the antigen-antibody reaction by using enzymatic activities this was achieved by using ELISA to examine whether substances mainly proteins serving as indicators of some diseases are detected in blood or not, which is helpful for making a diagnosis.

• Wrote and executed qualification protocols on process equipment and other production processes.

Science Teacher - Wellspring foundation, Connecticut Teaching all science subjects

Science Teacher - Manchester Community College Manchester, Ct Teaching Biology, Anatomy, physiology, organic, and inorganic Chemistry. Hartford Hospital/American Heart Association. Hartford, Ct Research Assistant

Assist in Laboratory research project concerning Immunoenhancement of neonatal host defense and in vitro effect of pentoxifylline on human neonatal PMN function by apply- ing analytical methods.

Education and Certificates

Quinnipiac College, Hamden Connecticut

Master of Science in Laboratory Science with Concentration in Chemistry (Candidate) Bachelor of Science, Radiology Science with Concentration in Management Manchester Community College. Manchester Connecticut Associate Degree in Science

College of Art and Technology. Newcastle England

“A” level Degree, Chemistry, Physiology, and Biology

“O” level Degree, Chemistry, Mathematics, and Biology

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