Angelly Peralta
Summary
Innovative engineer with background in diverse engineering projects, including design optimization and process improvement. Strong analytical skills, adept at problem-solving and implementing efficient solutions to enhance productivity. Proven ability to lead teams towards achieving project goals within deadlines, significantly improving operational efficiency and reducing costs.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Engineer/Scientist II (Bioanalytical Purification)
Thermo Fisher Scientific
11.2022 - Current
- Subject Matter Expert (SME) in UPLC, AKTA PURE (FPLC), FT-IR, Particle Size Analyzer, Varioskan (Immunoassays), and Spectrophotometers.
- Proficient in Measurement Systems Analysis, Data Mining, Design of Experiments (DOE), Quality by Design (QbD), and Failure Mode and Effects Analysis (FMEA) using Minitab.
- Developed Standard Operating Procedures (SOPs) and provided technical support for MSAT/QC teams.
- Led method development, validations, risk assessments, feasibility studies, second source raw material qualifications, Validation cross-over from obsoleted instruments, and quality product improvements.
- Managed method transfers from R&D to QC Lab for GMP release, including training for QC analysts and supporting investigations and CAPAs
- Directed the POROS Stability program for Chelmsford/Bedford
- Prepared customer reports and coordinated internal audits in compliance with ISO 13485
Research Associate II Analytical Chemistry
Greenlight Biosciences
03.2022 - 11.2022
- R&D Platform Development: Contributed to mRNA vaccine research and development within GLP/cGMP frameworks
- Analytical Expertise: Subject matter expert in HPLC/UPLC, Ion Chromatography (IC), FTIR, and CE-SDS systems
- Bioanalytical Techniques: Conducted bioanalytical assays including nucleic acid quantification, qPCR, purity assays, ELISA, bioburden testing, endotoxin testing, and activity assays
- SOP Development: Developed and reviewed Standard Operating Procedures (SOPs) to ensure compliance with quality control standards
- Method Development & Validation: Supported the development and validation of analytical methods for future quality control and manufacturing applications
- Data Analysis & Communication: Analyzed and presented technical data effectively to internal R&D teams and external stakeholders
Chemistry Production Scientist
PETNET RADIOPHARMACEUTICALS
03.2021 - 03.2022
- Production of PET pharmaceuticals by performing complex compounding, manufacturing cGMP (cyclotron and chemistry module operation)
- Quality control testing (utilizing analytical equipment TLC, HPLC, GC, LC, bioburden, endotoxin)
- Participate in complex inspections (FDA, OSHA, EPA), troubleshooting to support manufacturing and testing processes
- Implement approved SOP changes to production and quality control processes
Lab Technician II (Micro/Molecular biology)
Cambridge Health Alliance
Cambridge, USA
07.2020 - 03.2021
- Experience with diagnostics and theories of microbiology and molecular biology including quantitative Real-Time PCR, Liquid Handling, and bioassays
- Media preparation, specimen processing, aseptic techniques
- Maintain well documented records of analytical data and laboratory notebooks
- Performs troubleshooting of instruments, QC and inventory
Clinical Lab Tech
Beth Israel Deaconess Medical Center
Boston, USA
06.2017 - 08.2020
- Raw material quality inspections, and inventory management
- Perform point of care immunoassays, Spectrophotometry, qPCR, Flow-cytometry (CSF)
Independent Research
University of Massachusetts Lowell
- Using functional genomics to characterize consequences of a mutation in MFGE8 on mammary cell function
- In vitro mammalian cell culture, protein quantification, and modeling genetic disease conditions in cell lines
- Assay development for protein quant
- Techniques used: Fluorescent/colorimetric reporter assays, Immunoblot, RNA isolation, qPCR, Fluorescence microscopy, transfection, cell culture, LC/MS, and UPLC.
Education
MS - Biomedical Engineering and Biotechnology
University of Massachusetts Lowell
Lowell, MA12-2024
BS - Applied Biomedical Sciences in Clinical Lab Sciences and Biotechnology
University of Massachusetts Lowell
Lowell, MACertification
- Green belt certification, in progress
- ISO 13485, certified
Publications
Approach to the registration of Analytical Methods -Implementation of ICH Q2& R2 and Q14 for Biologics., BioPhorum
Affiliations
- ESL tutor
Languages
Spanish
Native/ Bilingual
Portuguese
Native/ Bilingual
Timeline
Engineer/Scientist II (Bioanalytical Purification)
Thermo Fisher Scientific
11.2022 - Current
Research Associate II Analytical Chemistry
Greenlight Biosciences
03.2022 - 11.2022
Chemistry Production Scientist
PETNET RADIOPHARMACEUTICALS
03.2021 - 03.2022
Lab Technician II (Micro/Molecular biology)
Cambridge Health Alliance
07.2020 - 03.2021
Clinical Lab Tech
Beth Israel Deaconess Medical Center
06.2017 - 08.2020
Independent Research
University of Massachusetts Lowell
MS - Biomedical Engineering and Biotechnology
University of Massachusetts Lowell
BS - Applied Biomedical Sciences in Clinical Lab Sciences and Biotechnology
University of Massachusetts Lowell
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