Neda Sadeghiani Pelar
Irvine,CA
Summary
Experienced and collaborative Project Manager with a proven track record in R&D and drug product development. Skilled in successfully managing complex projects within budget and regulatory constraints. Adept at team leadership, risk management, and stakeholder communication to deliver exceptional results. Currently enhancing leadership skills through the 'Dynamic Leadership Path' by the International Toastmasters and contributing to community initiatives as a PR member of the Iranian American Chamber of Commerce event planning management committee since 2015. Passionate about nature and outdoor activities, with extensive leadership experience organizing hiking and camping expeditions as a Sierra Club Leader. Seeking opportunities to leverage project management expertise to support local small businesses and nonprofit organizations.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Manager R&D
Hycor Biomedical, INC
01.2023 - 03.2024
- Directed high-performing protein chemistry team for allergen production, supporting allergy diagnostics.
- Achieved project milestones within established timeframes.
- Supervised and motivated employees for productivity and engagement.
- Facilitated onboarding of new employees with training and documentation.
- Executed timely transfer of 80% of extracted allergens to Manufacturing, optimizing revenue flow.
- Negotiated and onboarded qualified vendors, reducing monthly costs by 30%.
- Defined project phases and timelines through cross-department collaboration.
- Conducted data analysis and optimized methods for efficiency and quality.
- Ensured regulatory compliance with GMP, FDA, ICH, and 21 CFR.
- Mitigated risks by communicating with stakeholders, ensuring smooth project progress.
- Coordinated global cross-functional collaboration for seamless project execution.
Principal Scientist
Nitto Avecia Biopharma Services
09.2021 - 11.2022
- Delivered performance goals and ensured revenue flow for the biochemistry department.
- Planned and executed method development and validation for API/DS and DP in a cGMP environment based on ICH and FDA regulations.
- Acted as subject matter expert (SME) to guide the project manager.
- Collaborated with cross-functional teams to meet milestones on schedule and within budget.
- Assisted project lead in stakeholder communication and technical data presentation.
- Prepared quality technical documentation/reports, and conducted complex method testing.
- Managed department budget of 50k per year for equipment and supply and 5 full-time employees.
R&D Project Manager / Senior Scientist
AJK Biopharmaceutical, LLC
01.2020 - 09.2021
- Managed all aspects of the project management process from planning to closure.
- Contributed to the commercialization of a PEGylated nanopeptide drug delivery agent from feasibility to pre-commercialization.
- Planned drug delivery lab projects, including contracts, scope of work, documentation, and resource forecasting.
- Monitored project progress and provided regular updates to upper management.
- Facilitated business development meetings with internal and external stakeholders and contractors using virtual communication tools.
- Identified project risks and developed mitigation strategies with team members.
- Analyzed data and reviewed ICH guidelines to assess companion documents, APIs, and DS of new compounds.
- Oversaw the scientific team of 3 scientists, identified action items, held the team accountable, and prepared reports and presentations for stakeholders.
Scientist / Lab Manager
Chapman University
06.2017 - 12.2019
- Managed lab projects, secured a $250K NIH grant, and achieved Health Department approval.
- Designed and executed innovative in vitro research projects for drug delivery systems targeting cancer and infectious diseases.
- Conducted data analysis, and prepared SOPs, protocols, and manuscripts, ensuring regulatory compliance.
- Provided leadership and mentoring to graduate students and lab personnel.
- Prepared and presented project updates at weekly/monthly team meetings and cross-departmental seminars and conferences.
- Ensured proper lab equipment functionality by collaborating with vendors and the facility department.
Academic Research Scientist
Chapman University
03.2015 - 05.2017
- Led prostate cancer field-cancerization and NF-B pathways projects, fostering a collaborative environment among team members to achieve research milestones.
- Contributed to the approval of a $50K grant by the DOD through effective communication and collaboration with grant-writing team members.
- Built in-depth knowledge and insights of cGMP, GLP, GDP, ICH, ISO, and CFRs by actively engaging in discussions and knowledge-sharing sessions with peers at FDA conferences.
- Networked and built a strong presence with peers to facilitate professional relationships, fostering an environment of mutual support and collaboration.
- Collaborated closely with team members to optimize workflow and achieve project objectives, leveraging interpersonal skills to navigate challenges and ensure successful outcomes.
- Contributed valuable specialist input to research activities based on professional expertise, actively engaging with colleagues to share insights and perspectives.
- Engaged in scientific research on multiple projects, collaborating with interdisciplinary teams to drive innovation and achieve research goals through effective teamwork and communication.
Research Associate
UCLA Medical Center
03.2014 - 12.2014
- Successfully conducted 8 mutations on the LPL gene, contributing to potential treatments.
- Conducted comprehensive literature reviews to inform study designs and methodology decisions.
- Prepared samples for analysis by performing complex sample preparation tasks.
- Learned and performed complex molecular biology techniques to provide valuable contributions.
Education
Ph.D. - Molecular Biology & Genetics
University of Brasilia
Brasilia, Brazil01.2009
Master of Science - Molecular Biology & Genetics
University of Brasilia
Brasilia, Brazil08.2004
Bachelor of Science - Nursing
Shahid-Beheshti University
Tehran, Iran02.1995
Certification - Project Management
University of Irvine (UCI)
Irvine12.2022
IACUC Certification -
Collaborative Institutional Training Initiative
Menphis, TN2018
Introduction To The Principles And Practice of Clinical Research (IPPCR) - Clinical Research
NIH Clinical Center
Maryland, NY12.2013
Translational Medicine Certification - Translational Medicine
University of Los Angeles & MRF
Los Angeles, CA12.2012
Skills
Areas of Expertise & Knowledge
- Project Management & Execution: Project Planning & Execution; Risk Management & Mitigation saving up to 100k/y by choosing the qualified vendors offering cheaper raw materials and shortest lead time; Stakeholder Communication & Relationship Management; Cross-Functional Team Leadership
- Soft Skills & Adaptability: Teamwork & Collaboration; Adaptability & Decision-Making in Complex Environments; Problem-Solving & Innovative Thinking; Interpersonal Skills; Leadership Abilities; Empathy and Understanding; Mentoring and Coaching; Self-Awareness; Ethics & integrity; Customer Service Orientation
- Regulatory Compliance & Quality Assurance: FDA Regulations & Compliance Standards; Quality Control & Assurance Processes
- Bioinformatics Skills: Microsoft Office; Smartsheet; LIMS; SharePoint; Metronome
- Biotechnology Research & Development: Experimental Design & Optimization; Biologic Testing & Analysis; Technology Implementation in R&D Projects
- Scientific Proficiencies: Animal Studies & Cell-Based Assays; Molecular Biology Techniques; Cancer Treatment; Biochemical Assays & Analysis Methods; Technical Documentation
Certification
Project Management Certificate Program
Personal Interests
My passion for nature has given me significant leadership experience organizing and leading hiking and camping expeditions. I am actively involved in sports such as volleyball and biking. My future goals include participating in "The Amazing Race" and mastering pickleball. I thrive on challenges and am committed to continuous learning, particularly in project management roles. Currently, I am a freelance project manager, assisting local small businesses in initiating and executing projects with a strong foundation in project management processes.
Timeline
Manager R&D
Hycor Biomedical, INC
01.2023 - 03.2024
Principal Scientist
Nitto Avecia Biopharma Services
09.2021 - 11.2022
R&D Project Manager / Senior Scientist
AJK Biopharmaceutical, LLC
01.2020 - 09.2021
Scientist / Lab Manager
Chapman University
06.2017 - 12.2019
Academic Research Scientist
Chapman University
03.2015 - 05.2017
Research Associate
UCLA Medical Center
03.2014 - 12.2014
Ph.D. - Molecular Biology & Genetics
University of Brasilia
Master of Science - Molecular Biology & Genetics
University of Brasilia
Bachelor of Science - Nursing
Shahid-Beheshti University
Certification - Project Management
University of Irvine (UCI)
IACUC Certification -
Collaborative Institutional Training Initiative
Introduction To The Principles And Practice of Clinical Research (IPPCR) - Clinical Research
NIH Clinical Center
Translational Medicine Certification - Translational Medicine
University of Los Angeles & MRF
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