Lia Yang
Durham,NC
Summary
Results-driven Biomanufacturing Professional with over 4 years of experience in cGMP environments, specializing in tech transfer, process improvement, and regulatory and regulatory compliance (GMP, GLP, GDP) within ISO-classified cleanrooms and BSL-2 environments compliance. Expertise in mammalian and bacterial cell culture, protein purification, Next Generation Chromatography, Western blotting, and HPLC. Demonstrates strong adaptability and collaboration in team settings, contributing to efficient manufacturing operations.
Overview
5
5
years of professional experience
Work History
Bio-Manufacturing Associate II
Avion, Inc
Durham, NC
07.2022 - 09.2025
- Cultivated and maintained multiple mammalian (HEK-293, Hybridoma) and bacterial cultures for Internal/External and CDMO use.
- Executed cell culture operations and material handling within Biological Safety Cabinets (BSCs) under cGMP standards.
- Purified recombinant protein through Size Exclusion Chromatography (SEC) and Immobilized Metal Affinity Chromatography (IMAC), ensuring quality and integrity of final product.
- Programmed, computed, and analyzed protein purifications using Next Generation Chromatography (NGC).
- Characterized manufactured biomaterial's using SDS-PAGE, Western blot, densitometry, Reverse Phase HPLC, and BCA protein assay.
- Facilitated tech transfer from R&D to GMP by monitoring processes and developing methods to enhance GMP compliance and process efficiency.
- Guided co-workers on GMP standards and regulatory guidelines.
- Performed aseptic techniques in ISO-classified cleanrooms, following gowning procedures to maintain sterility and prevent contamination.
- Conducted experimental and manufacturing activities in BSL-2 laboratory environments, ensuring compliance with biosafety protocols.
- Executed routine and action limit testing using aseptic techniques in accordance with GMP, GDP, and GLP regulations, supporting contamination control and identifying process limitations.
- Performed environmental monitoring of air, surfaces, temperature, and pressure to ensure compliance with cleanliness requirements in cleanroom and non-cleanroom settings.
- Managed inventory of raw materials and finished products by overseeing ordering, storing, and tracking processes.
Manufacturing Associate I
Avioq, Inc
Durham, NC
02.2021 - 07.2022
- Manufactured materials following Manufacturing Directions (MDs) and GMP regulations.
- Calibrated and performed routine maintenance on test equipment, cleaned and sterilized laboratory equipment for equipment and log documentation.
- Measured raw materials and maintained inventory.
- Practiced ISO gowning procedures and aseptic handling inside Biological Safety Cabinets (BSCs).
- Worked routinely in BSL-2 classified spaces following biosafety and contamination control guidelines.
- Executed buffer and media preparation to ensure accurate and consistent experimental conditions. with complete process documentation.
Education
Bachelor of Science - Biochemistry
The University of North Carolina At Greensboro
Greensboro, NC05-2020
undefined
Skills
- Protein purification and chromatography
- Analytical and aseptic techniques
- Compliance and operations
- Manufacturing and quality control
- Data management and software
- Professional skills development
- Environmental monitoring
- Cell culture operations
- GMP compliance
- Inventory management
- Process documentation
- Biosafety protocols
- Problem solving and troubleshooting
- Attention to detail
- Effective communication and active listening
- Team collaboration and safety awareness
- Adaptable learning and technical training
- Time management abilities
- Organizational skills
- Cell culture
- Protein purification
- Chromatography techniques
- Aseptic technique
- Manufacturing compliance
- Process improvement
- Quality assurance
- Team collaboration
- Technical documentation
- Problem solving
- Regulatory guidance
- Effective communication
- GMP and GLP adherence
- Time management
- GMP regulations adherence
- GMP regulations
- cGMP compliance
- CGMP regulations
- Compliance with gmps
- Aseptic techniques
- Manufacturing operations
- Quality control testing
- Documentation practices
- Technical training
- GLP and GCP compliance
- GLP compliance
- GLP adherence
- GLP and GMP knowledge
- Good laboratory practices (GLP)
- Cell culture techniques
- Chromatography application
- Aseptic processing
- Regulatory compliance
- GMP guidelines
- Equipment calibration
- Teamwork and collaboration
- Excellent communication
- Communication
- Collaboration
- Multitasking
- Leadership
- Team building
- MS office
- Analytical
- PPE compliance
- Training and mentoring
- Documentation and reporting
- Verbal and written communication
- SOP enforcement
Core Competencies
Mammalian & bacterial cell culture, monoclonal antibodies (mAbs), recombinant protein expression, NanoDrop analysis, Size Exclusion Chromatography (SEC), Immobilized Metal Affinity Chromatography (IMAC), Next Generation Chromatography (NGC) programming & data analysis, Reverse-phase HPLC, ELISA, immunoassays, chromatography, SDS-PAGE, Western blotting, densitometry, spectrophotometry, BCA assays, GMP, GLP, GDP, ISO gowning (Grade A–D cleanrooms), BSC operations, BSL-2 practices, aseptic technique, Tech transfer, SOPs, representative sampling, Quality Control (QC), root cause analysis, manufacturing procedures (MPs), process development (PD), Electronic Batch Records (EBR), Job Hazard Analyses (JHAs), process qualification (PQ), operational qualification (OQ), inventory management, Data and statistical analysis, LIMS, Microsoft Office Suite, Leadership, training, clear communication, problem-solving, adaptability, cross-functional team collaboration
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
swipe to browse
Timeline
Bio-Manufacturing Associate II
Avion, Inc
07.2022 - 09.2025
Manufacturing Associate I
Avioq, Inc
02.2021 - 07.2022
Bachelor of Science - Biochemistry
The University of North Carolina At Greensboro