BETHELHEM ADEM
Falls Church
Summary
Highly-motivated employee with desire to take on new challenges. Strong worth ethic, adaptability and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Associate Quality Control Chemist
GSK
10.2023 - Current
- Conduct routine testing for in-process, release, and stability drug product samples according to Standard Operating Procedures (SOP).
- Experience in various analytical methods, such as HPLC (Ion Exchange, Size Exclusion Chromatography, Affinity Titer), Protein concentration determination using Solo-VPE and Absorbance at 280 nm,
- Develop a deep understanding of cGMP and other regulatory guidelines to ensure laboratory and procedure compliance.
- Basic understanding of instrument operations and troubleshooting skills in multiple techniques
- Knowledge of LIMS, M-ERP, Agilent Openlab/Chemstation, and Alliance WATERS
- Monitored production processes to ensure compliance with established quality control standards.
- Maintained records of inspection results, test methods used and other relevant information regarding quality assurance activities.
Scientist I
Eurofins Lancaster Laboratories
02.2022 - 10.2023
- Possess cGMP and GLP experience
- Experience in bioassay activities such as passaging different CHO cell lines, preparing media, and reviewing logbooks
- Determine relative potency using a CRE reporter gene
- Participates across multiple analytical disciplines
- Perform analytical testing for lot release, stability, and method qualification according to the written procedure
- Perform tests using affinity chromatography (LAMBDA/Protein A), pH, Osmolality, Moisture estimation, and Protein concentration determination using Solo-VPE and Absorbance at 280 nm
- Analyze and report data following GxP requirements
- Review documentation (batch records, SOPs, Logbooks) for completeness, clarity, accuracy and submit edits to documents
- Independently perform sample management responsibilities and provide routine support to sample management, including receiving, logging, and dispatching samples
- Experience working in Labware Laboratory Information System (LIMS) and Chemistry electronic laboratory notebook (eLN)
- Proficient in using MS Office suite and other data analysis software such as DLIMS and Agilent OPENLAB.
Research Assistant I - Specimen Processor
Henry M. Jackson Foundation
02.2020 - 02.2022
- Receive and accession biospecimens following standard operating procedures (SOPs)
- Processed HIV, Influenza, Yellow fever, and Covid-19 biospecimens to isolate high volume PBMCs using Vi-Cell Analyzer
- Inspected and determined specimens for quality and documentation for data accuracy based on specimen rejection criteria
- Proficient in Freezer-works
- Managed specimen processing and all laboratory activities (Preventative maintenance on laboratory equipment) in compliance with GMP regulation
- Prepared specimens and related data for shipment/transfer to outside laboratories, collaborators, and investigators/Institutions
- Received, documented, and stored biological specimens in appropriate conditions
- Followed GxP standards for operations in a biorepository and the laboratory.
Education
Graduate Certificate program - Personalized Medicine
George Mason University
05-2022
Bachelor of Science (B.S.) - Biotechnology
James Madison University
Harrisonburg, VA05.2019
Skills
- Strong organizational skills, time management, attention to detail, and accuracy The ability to work independently and in a team environment
- Knowledge of the CGMP regulations and working in a GMP environment for five years
- Knowledge of Good Documentation Practices
- Preparation of media and solutions for cell culture
- Proficient in communicating in English and Amharic
- Knowledge of ACS Software, SPSS, Freezer work, ELN, and OpenLab CDS, QLIMS, MERP, EMPOWER
- Excellent Verbal and written communication skills
- knowledge of Chemical Handling (Safety Data Sheets (SDS)
- Knowledge of sterilization techniques and equipment
Certification
- National Certified Phlebotomy Technician through NHCO
- American Heart Association BLS CPR and AED Certification
- First Aid Certification
Timeline
Associate Quality Control Chemist
GSK
10.2023 - Current
Scientist I
Eurofins Lancaster Laboratories
02.2022 - 10.2023
Research Assistant I - Specimen Processor
Henry M. Jackson Foundation
02.2020 - 02.2022
Graduate Certificate program - Personalized Medicine
George Mason University
Bachelor of Science (B.S.) - Biotechnology
James Madison University
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