Neda S Pelar, Ph.D.

Experience

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  Hospitals

  May 1994 - Aug 2000

  Certified Nurse-Midwife (CNM)

  • Provided full-scope midwifery care to women and neonates in hospital and at home;• Provided counseling and psycho-socio-emotional support; • Assisted with CQI program and initial set-up of two women centers for full-scope midwifery services and a center for Labor-Delivery-Recovery-Postpartum operation;• Successfully implemented educational public workshops, seminars, and presentations in order to increase women and targeted population general health, diseases, and prevention awareness;• Supervised the patient’s care team, identified, planed, implemented and evaluated the nursing care requirements for patients. Show less

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  Universidade de Brasília

  Jan 2001 - Nov 2010

  Graduate Researcher(MS and PhD)

  Successfully proved that the anti-cancer drug, magnetite nanoparticles (PAMF), is highly biocompatible and a strong candidate for a versatile cancer drug delivery system• Verified the biocompatibility, biodistribution, and anticancer effects of PAMF in healthy and tumor-bearing mice in the presence and absence of an alternate magnetic field to induce heat• Employed following methodologies to verify the drug’s biological effects: NMR, MTT, AgNOR staining for Fe, IHC, FACS, Blood analysis, Microsurgery, Histology, Light and Electron microscopy, Mitotic Index, Genotoxicity assay, Cell Death Assay, Solid tumor inoculation, and tissue culture• Analyzed data statistically using SPSS15 software including Means, t-test, ANOVA, Mann-Whitney• Developed and established new protocols and SOPs for fluid and solid tumor inoculation, processing, and staining for NMR and microscopic analysis• Participated in staff employment, student selection, lab management, and purchase of new devices • Taught Immunology and Histology to undergrads students Show less

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  UCLA Biomedical Research Dep. and MRF

  Mar 2012 - Jul 2012

  Translational Medicine Certification and Consultant

  • Evaluated the clinical drug development process from preclinical to phase III to marketing;• Inspected and reported the reasons for failure of 10 drugs developed in phase II and III;• Knowledgeable to design successful drug development plans by considering well-proposed hypotheses, biomarkers, methodologies, therapeutic PK/PD , target modulation, dose response, exposure response, and in vitro /in vivo/ in human interrelation;• Contributed to a non-profit organization, MRF, in accelerating time to market for new medicines. Show less

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  UCLA Medical School, Div. Cardiology

  Mar 2014 - Dec 2014

  Research Assistant

  Successfully conducted mutations on the LPL gene, contributing to potential treatments.

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  Chapman University School of Pharmacy

  Mar 2015 - May 2017

  Postdoctoral Fellow

  Led cancer field cancerization and NF-KB pathways projects. Contributed to the approval of a $50K grant by the DOD. • Built in-depth knowledge and insights of cGMP, GLP, GDP, ICH, ISO, and CFRs by attending FDA conferences.

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  Language Door, Inc

  Jan 2016 - now

  Freelance Project Manager
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  Chapman University

  Jun 2017 - Dec 2019

  Laboratory Operations Manager

  Managed several lab projects, secured a $250K NIH grant, and achieved Health Department approval.• Designed and executed innovative in vitro research projects that serve as drug delivery systems for cancer and infectious disease treatments. • Conducted data analysis, prepared SOPs, protocols, and manuscripts, and ensured regulatory compliance.• Provided leadership and mentoring to graduate students and lab personnel.• Prepared and presented weekly/monthly project updates to the team and cross-departmental seminars and conferences.• Ensured proper lab equipment and instrument functionalities by working closely with vendors and the facility department. Show less

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  AJK Biophatmaceutical LLC.

  Jan 2020 - Sept 2021

  R&D Project Manager

  Facilitated all aspects of the project management process from planning, initiation, execution, control, and closure. Contributed to the successful commercialization of a drug delivery PEGylated nanopeptide agent to the market from feasibility to pre-commercialization phases. • Planned the drug delivery lab projects’ activities including contracts, scope of work, documentation, and resource forecast.• Monitored project progress and represented the project by regularly providing updates to upper management.• Facilitated business development meetings with internal and external business owners and key stakeholders.• Identified project risks and created mitigation strategies with the project members.• Analyzed data and reviewed ICH guidelines to assess companion documents, APIs, and DS of new compounds accordingly. • Oversaw the scientific team, identified the action items holding the team accountable, and prepared reports and presentations for project owners and involved partners. Show less

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  Nitto Avecia Pharma Services

  Sept 2021 - Nov 2022

  Principal Scientist

  Surpassed assigned target performance goals in a pharmaceutical services company.• Planned and executed method development and validation for API / DS and DP in a cGMP environment based on ICH and FDA regulations and guidelines.• Served as subject matter expert (SME) in the projects to guide project managers.• Worked with cross-functional teams to meet milestones on schedule and within budgets.• Supported project lead in stakeholder communication and technical data presentation.• Prepared quality technical documentation, and reports, and conducted complex method testing. Show less

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  Hycor Biomedical LLC

  May 2023 - Feb 2024

  Manager R&D Biochem

  Led a high-performing protein chemistry team specializing in allergens (native and recombinant) production, supporting the Company’s medical device platforms for allergy diagnostics. Successfully transferred over 80% of extracted allergens to the Manufacturing Department on time, optimizing revenue flow. Strategically identified and onboarded qualified vendors offering quality raw materials at reduced costs and faster lead times, resulting in a significant 30% monthly cost reduction. • Established project’s phases timelines from development to validation and transfer to the manufacturing department, by diligently working with planning, procurement, project management, QA, and upper management. • Analyzed data and executed troubleshooting to optimize methods for extracts’ purification and downstream processing, enhancing efficiency and quality control.• Managed and ensured compliance with a range of regulatory standards including GMP, FDA, ICH, and 21 CFR, by closely collaborating with manufacturing, TechOps, QC, and QA. • Proactively identified and communicated risks to stakeholders in a timely and clear manner, mitigating potential project disruptions and ensuring smooth progress.• Drove cross-functional collaboration globally, engaging teams in China, the EU, and internal departments to ensure seamless project execution.• Assisted in preparing FDA, Due Diligence, POC, ICH, CFR 21, 510K, IVD, and IVDR documentation for NOVEOS and NOVEOS flex devices. Ensured Compliance for USA, EU, and China markets. Show less