MARGI DARJI
Burlington,USA
Summary
Detail-oriented and results-driven Manufacturing Associate with extensive expertise in cell therapy, microbiology, and GMP-compliant manufacturing. Proficient in aseptic processing, meticulous documentation practices, and data analysis within FDA-regulated environments. Proven track record of supporting deviations, CAPA initiatives, and continuous improvement of SOPs to enhance operational efficiency. Dedicated to maintaining quality, compliance, and continuous improvement in manufacturing processes.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Manufacturing Associate I
Minaris Advanced Therapies (formerly WuXi AppTec)
Philadelphia, PA
06.2024 - 07.2025
- Executed manufacturing processes for commercial and clinical cell therapies under FDA, Annex 1, CFR Title 21, and cGMP guidelines.
- Performed TIL Cell Therapy operations including thawing, cell passage, expansion, harvesting, and aseptic documentation.
- Collected, reviewed, and interpreted scientific data in compliance with GDP; identified trends for quality and process improvement.
- Operated, cleaned, and maintained complex bioprocess equipment; prepared media and cleaning solutions.
- Participated in deviation investigations, root cause analysis (RCA), and Corrective and Preventive Actions (CAPA).
- Supported validation efforts and trained on new processes and documentation systems.
- Collaborated cross-functionally and actively communicated in team huddles to support seamless operations.
Medical Billing Process Associate
Integrity Healthcare Solution Pvt. Ltd.
Gujarat, India
10.2022 - 03.2023
- Specialized in cardiology (heart-related) medical billing, managing claims for 3 cardiologists with high-volume processing.
- Processed insurance claims using accurate CPT/ICD-10 codes and obtained authorizations for procedures.
- Maintained patient billing documentation in Excel and ensured audit readiness.
- Communicated with physicians and insurance providers to streamline approval and resolve claim issues.
- Collaborated in a team of 6 specialists; escalated and resolved billing discrepancies.
Education
Master of Science (M.Sc.) - Microbiology
Gujarat University
India05.2021
Bachelor of Science (B.Sc.) - Microbiology
Gujarat University
India05.2019
Skills
- Aseptic Techniques & Cleanroom Practices
- GMP and GDP compliance expertise
- Tumor-infiltrating lymphocyte therapy
- DNA/RNA extraction, qPCR
- SOP & Batch Record Documentation
- Viable and non-viable particle assessment
- Equipment Operation & Maintenance
- Sample Collection & Analytical Testing
- Deviation, RCA & CAPA Participation
- Microsoft Office: Word, Excel, PowerPoint
Certification
- Proteomics Workflow: Sample Preparation to Sequencing – Online
- Medical Bacteriology (Phase 3) – Sacred Heart College, Tamil Nadu, India
Timeline
Manufacturing Associate I
Minaris Advanced Therapies (formerly WuXi AppTec)
06.2024 - 07.2025
Medical Billing Process Associate
Integrity Healthcare Solution Pvt. Ltd.
10.2022 - 03.2023
Bachelor of Science (B.Sc.) - Microbiology
Gujarat University
Master of Science (M.Sc.) - Microbiology
Gujarat University
ACADEMIC RESEARCH EXPERIENCE
- Gujarat University — Ahmedabad, India
- M.Sc. Research Project: Phenol Degradation by Bacteria September 2020 – May 2021
- Isolated and characterized phenol-degrading bacteria from environmental spill sites.
- Conducted microcosm studies and phenol degradation assessment through absorbance at 375nm.
- Verified 2-hydroxymuconic semialdehyde production as a phenol breakdown product.
- Analyzed data using spectrophotometry and presented results in technical reports to faculty panels.