NAKISHA MELENDEZ
Piscataway,NJ
Summary
Dynamic Cell and Gene Therapy Associate at Minaris Advanced Therapies, skilled in GMP compliance and sterile techniques. Successfully led team operations to enhance production quality, while collaborating cross-functionally to achieve targets.
Overview
6
6
years of professional experience
Work History
Cell and Gene Therapy Associate
Minaris Advanced Therapies
Allendale, New Jersey
01.2025 - Current
- Operated and maintained equipment in controlled clean-room environment under strict GMP, SOPs, FDA regulations, and compliance protocols, ensuring high product quality and patient safety
- Handled patient blood products with precision and strict sterile technique to maintain sample integrity
- Performed aseptic processing, labeling, and documentation to ensure full traceability of patient samples
- Collaborated with cross-functional teams (QA, QC, management) to achieve production and quality targets, enhancing workflow efficiency
- Led and coordinated team operations as process verifier during production runs and capacity runs
- Trained to review Master Batch Records following processing to ensure accuracy, completeness, and compliance with established procedures and quality standards
Lab Technician Assistant/Insurance Verification Specialist
ENT And Allergy Associates LLP
07.2020 - 12.2024
- Led transition to paperless system by organizing and scanning patient charts, enhancing accessibility and efficiency
- Diluted, labeled, and packaged vials of allergen extract.
- Verified insurance benefits for allergy immunotherapy patients, ensuring accurate patient care and coverage
- Explained insurance benefits and out-of-pocket expenses to patients, facilitating informed treatment decisions
Education
Master of Science - Bioinformatics and Genomics
NJCSTM Kean University
Union, NJ08-2022
Bachelor of Science - Cell and Molecular Biology
Kean University
Union, NJ05-2019
Skills
- GMP Compliance
- Sterile Procedures and Techniques
- Cleanroom Gowning and Manufacturing
- Cell Culture and Transduction Processing
- CD34 Cell Isolation and Enrichment
- Lentiviral Vector Handling
- Final Product Formulation and CryoPreparation
- Sepax, CliniMacs, Centrifuge
- ELISA
- PCR
- Western Blot
- Cell lines: THP-1, HeLa, HepG2
Timeline
Cell and Gene Therapy Associate
Minaris Advanced Therapies
01.2025 - Current
Lab Technician Assistant/Insurance Verification Specialist
ENT And Allergy Associates LLP
07.2020 - 12.2024
Master of Science - Bioinformatics and Genomics
NJCSTM Kean University
Bachelor of Science - Cell and Molecular Biology
Kean University