Meron Kidanemariam
Houston,TX
Summary
Experienced Biotechnology professional with 5 years of expertise in GMP-regulated clinical processes, quality assurance, and laboratory operations. Seeking to leverage my skills in compliance, material management, and technical leadership to contribute to innovative solutions and operational excellence in a forward-thinking organization.
Overview
5
5
years of professional experience
Work History
Cell Therapy Core Technician III
Lonza
11.2021 - Current
- Responsible for carrying out clinical processes in an FDA regulated GMP facility
- Conducts real time on the floor logbook review, reviewing of cGMP records, and change control process forms
- Usage of the Track wise system to open, investigate, and resolve pending deviations to support lot release
- Materials point of contact for commercial grade client products & project orange liaison
- Perform SAP transactions for materials and associated equipment to align with both company policy and federal regulations
- Qualified reviewer and trainer of clients executed batch records
- Monitored QA procedures for adherence by employees, notifying personnel of non-compliance issues to avoid applicable deviations
- Qualified in environmental monitoring for clinical processes, ensuring optimal conditions for patient safety, infection control, and compliance with healthcare regulations.
Instructional Assistant
Univeristy Of Houston
06.2020 - 06.2021
- Assist lab manager in prepping chemical reagents and solution required for an experimental session for Bioprocessing and Biotech Research Method classes
- Perform plasmid isolation & DNA quantification, Gel Electrophoresis, Restriction digestion, and PCR
- Assist Bioprocessing students in the Upstream process using BioFlo 115 Bioreactors and Downstream process using AKTA PrimePlus for Size- exclusion chromatograph, Ion- exchange chromatography & Diethyl Amino Ethyl chromatography and Bradford assay
- Assist students to confirm lab result by running spectrometry with Tecan SPARKS, SDS PAGE, Enzyme activity assay
- Organized laboratory supplies, documents and equipment
- Prepared chemical samples, proper chemical containers and labels
- Maintained laboratory hygiene
- Analyzed and documented all supply request forms, supported online laboratory operations
Education
Masters Degree - Biotechnology
University of Houston
Houston, TX12.2021
Bachelor's Degree - Biotechnology
University of Houston
Houston, TX12.2019
Skills
- Trackwise
- Error Prevention System (EPS)
- CAPA
- Train the Trainer
- Safety Committee Chair Member
- CGMP Compliance Knowledge
- Lean Sigma Qualified
- Team Leader
- CPR Certified
Timeline
Cell Therapy Core Technician III
Lonza
11.2021 - Current
Instructional Assistant
Univeristy Of Houston
06.2020 - 06.2021
Masters Degree - Biotechnology
University of Houston
Bachelor's Degree - Biotechnology
University of Houston
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