BAHAR GHOBADI
Canoga Park,CA
Summary
Results-driven project management professional with extensive experience in cGMP, sterile techniques, and biotechnology operations. Proven track record in successfully managing projects, ensuring quality assurance and control, and driving process improvements to enhance drug substance and drug product operations. Expertise in technical documentation, problem-solving, and cross-functional collaboration, consistently delivering high-quality outcomes in dynamic environments. Eager to apply strategic process enhancements and project management skills to contribute innovative solutions within the biotechnology industry.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Manufacturing Associate - Filling/ Formulation Drug Products
TAKEDA
Thousand Oaks
04.2024 - Current
- Conducted multiple projects focused on enhancing drug product department operations.
- Developed new ideas and continuously revised SOPs through engaging presentations.
- Designed and delivered professional presentations to communicate project progress, key milestones, and deliverables to internal teams and cross-functional teams.
- Executed activities within a cGMP aseptic environment (Grade A and B areas), ensuring strict adherence to aseptic processing standards and protocols.
- Qualified in cGMP aseptic gowning and performed Quality Assurance duties, ensuring compliance with regulatory guidelines and maintaining sterile environments.
- Collaborated with cross-functional teams, including Quality Control, Environmental Monitoring, Analytical Quality Control, and Validation teams, to ensure seamless operation and regulatory compliance.
- Maintained and reviewed product run sheets, Standard Operating Procedures (SOPs), and manufacturing reports to ensure alignment with current Good Distribution Practices (GDPs).
- Monitored critical production processes in real-time using SCADA HMI, PROCON, Pi Vision, and Delta V, ensuring continuous compliance and product quality.
- Coordinated and validated hygiene-critical drug product processes, including lyophilization, vial washing, isolators, and aseptic material transfer chambers (MTC), before, during, and after filling operations.
- Conducted integrity testing for filters and aseptic isolator gloves, ensuring system integrity and maintaining a sterile environment before and after production.
- Set up and calibrated equipment for filling and capping operations according to run-sheets and schedules, optimizing production efficiency and reducing downtime.
- Oversaw and validated sterilization-in-place (SIP), cleaning-in-place (CIP), and vaporized hydrogen peroxide (VHP) processes to ensure compliance with sterile standards and prevent cross-contamination.
- Proactively identified process inefficiencies and collaborated with relevant teams to implement improvements, increasing overall production quality and reducing operational risks.
Lab Associate - Pre-Pivotal Drug Substance
AMGEN
Thousand Oaks
03.2022 - 06.2023
- Led cross-functional project teams in the planning, coordination, and execution of protein purification processes, including chromatography, viral filtration, and ultrafiltration/ diafiltration, ensuring timely and high-quality sample delivery.
- Managed and tracked project milestones related to sample collection, analysis, and coordination with internal teams (Quality Control, Rapid Analysis, Process Development, Warehouse, Supply Chain) to ensure alignment with project timelines and deliverables.
- Acted as the Subject Matter Expert (SME) for sample plan creation, New Product Introduction (NPI), and quality checks, overseeing the preparation and testing of buffers/media, and ensuring compliance with rigorous GxP guidelines.
- Led the transition from paper-based documentation to a fully electronic QMS database, improving efficiency, and ensuring compliance with industry standards and regulatory requirements.
- Reviewed, authored, and updated GMP SOPs, calibration reports, and protocols to ensure alignment with current processes and regulatory changes, maintaining documentation accuracy, and compliance.
- Utilized advanced data analysis tools (Unicorn, Delta V, Chrom-Lab, PI Vision) to monitor and troubleshoot operations, ensuring successful execution of daily tasks, and effective resolution of issues encountered.
- Implemented CAPA and process improvement strategies (Kaizen and Kanban) to address operational obstacles, ensuring continuous improvement in workflows, and maintaining high standards of product quality and safety.
- Coordinated calibration, installation, and troubleshooting of pH probes and chromatography skids, ensuring optimal functionality, and seamless integration into operations for successful project execution.
Microbiology Research Assistant
University of Wisconsin- Madison
Madison
01.2020 - 05.2020
- Demonstrated expertise in microbiology techniques, performing precise cell culturing, smearing, and staining of various bacteria strains, contributing to the identification and characterization of microbial samples
- Responsible for preparing assorted formulations such as agar plates and selective media, ensuring optimal conditions for microbial growth and facilitating future experiments while enumerating the number of colonies
- Expert in aseptic and sterile techniques to maintain a controlled laboratory environment, enforcing Good Lab Procedures and ensuring adherence to rigorous quality standards
- Excelled in detailed documentation and reporting of experimental procedures, observations, and results, ensuring accurate record-keeping and facilitating data analysis for research purposes
Education
Takeda Yellow Belt Certificate -
Takeda Pharmaceutical
Thousand Oaks, CA04.2025
Project Management Professional (PMP) Certificate -
Project Management Institution (PMI)
Los Angeles, CA11-2024
Bachelor of Science - Biology
University of Wisconsin-Madison
Madison, WI05.2021
Associate - Liberal Arts and Sciences
Madison Area Technical College
Madison, WI05.2018
Skills
- CGMP and sterile techniques
- Project Management Professional (PMP) techniques
- Quality assurance and quality control
- Team collaboration
- Team leadership
- Continual improvement
- Problem solving
- Technical documentation, SOP, and GDP
- Manufacturing software (EBR, LIMS, Word, Excel, PowerPoint, Smartsheet, Outlook)
- Excellent writing, Verbal and communication skills
- Detail-oriented
- Protein Purification
- Chromatography skids/HPLC
- Research and Development
- Cell culture and Filtration
- Aseptic Techniques
- Lab/ Data Analytics
- Operations management
- Automation Tools
- Microbiological Techniques/ Testing
Certification
- Project Management Professional (PMP) Training Certificate, 08/01/23, 11/01/23
- Six Sigma Yellow Belt Training Certificate, 08/01/24, Current
Extracurricular Activities
Innovation challenge, Fall-Spring 2016-2017, Winner of competition organized through the Center for Entrepreneurship Woman Soccer team, Fall-Spring 2016-2018 Involved in an Engineering invention project, 11/01/23, Entrepreneurship
References
Available upon request.
Timeline
Manufacturing Associate - Filling/ Formulation Drug Products
TAKEDA
04.2024 - Current
Lab Associate - Pre-Pivotal Drug Substance
AMGEN
03.2022 - 06.2023
Microbiology Research Assistant
University of Wisconsin- Madison
01.2020 - 05.2020
Takeda Yellow Belt Certificate -
Takeda Pharmaceutical
Project Management Professional (PMP) Certificate -
Project Management Institution (PMI)
Bachelor of Science - Biology
University of Wisconsin-Madison
Associate - Liberal Arts and Sciences
Madison Area Technical College
Similar Profiles
Zoé ValiquerZoé Valiquer
Apprenti technicienne en production pharmaceutique at TakedaApprenti technicienne en production pharmaceutique at Takeda
Anthony MundayAnthony Munday
Senior Research Associate II at TakedaSenior Research Associate II at Takeda
Clarissa AngClarissa Ang
Quality Control and Raw Material Intern at TakedaQuality Control and Raw Material Intern at Takeda