Victoria Butler
West Greenwich,RI
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Demonstrates strong analytical, communication, and teamwork skills, with proven ability to quickly adapt to new environments. Eager to contribute to team success and further develop professional skills. Brings positive attitude and commitment to continuous learning and growth.
Overview
15
15
years of professional experience
Work History
Sr. Scientist Attribute Sciences
Amgen
07.2023 - Current
- Lead for Immunoassay/DNA team-3 FTE staff and 1 EW
- Supports High Mass Programs for Manufacturing including qualifications of new samples and methods as applicable
- ARI PD Forensics Site business owner
- Enabled capability of new equipment in Forensics for alignment to network and enhanced support of investigations including SEM/EDS and LUMOS FTIR
- Developed staff member on Process Development compliance to take over as AS Compliance lead in 2025
- Mentored staff member to take over as the point of contact for AS stability studies
Scientist, Attribute Sciences
Amgen
09.2021 - 07.2023
Sr. Associate Scientist, Attribute Sciences
Amgen
04.2019 - 09.2021
- Lead a team of 7 contract staff in the Commercial AS group to support analytical testing
- Prioritize and schedule work for the Commercial AS group and communicate with process teams and customers to support testing and results
- Lead the ARI PD Compliance Team for internal and external audits
- Trained new staff on forensics process and techniques including FTIR and microscopy
- Lead incoming method transfers for new Amgen products
Associate Scientist, Attribute Sciences
Amgen
06.2017 - 04.2019
- Compliance Lead for Process Development supporting audits and inspections including responding to inspection requests and writing audit reports
- Supporting stability programs for process improvements and comparability studies supporting ARI site and Amgen network
- Business owner for Forensics and lead analyst: setting up new equipment in lab to support ARI manufacturing investigations
- Supporting new method transfers into ARI lab, co-validations with Quality
- Writing reports and technical documents in support of investigations, stability studies and commercial programs
- Ambassador for new graduate rotational program at ARI
- Mentor new level 3 staff member throughout 2 year rotational program in 3 departments
Senior Associate Attribute Sciences
Amgen
03.2013 - 07.2017
- Business owner for Forensics group in AS: Analyze extraneous matter samples from Manufacturing and PD using FTIR and microscopy techniques
- Compliance representative for AS team
- Attend monthly meetings, support compliance decisions, support audit and audit findings as needed
- Testing and method qualification for Anion Exchange HPLC method
- Set up and running of fraction collection for SE-UPLC characterization
- Create overlays using Empower software for multiple molecules to support FDA filings
- Safety representative for ARI AS on the global Safety Action Team for AS
- Attend meetings, complete safety walkthrough’s, follow up on action items for the team
Associate Attribute Sciences
Amgen
06.2010 - 03.2013
- Routine testing and Method Transfer of in process and drug substance samples using ELISA methods, Gel methods, columetric methods, and HPLC methods
- Utilize FTIR analysis and microscopy techniques for Manufacturing forensic analysis to determine particle make up
- Coordinated Stability studies and manage Stability samples for Analytical Sciences
- Author reports and technical spreadsheets in EDMQ documenting the Stability data
- Use PD LIMS to log in new stability studies and samples
- Coordinate with Quality on stability studies
- Safety lead for Analytical Sciences
- Attend monthly meetings, follow up on safety observations, coordinate and write Job Hazard Assessments for department
TWA-Process Development Cell Sciences
10.2009 - 06.2010
- Responsible for building and setting up 2L, 3L and 7L Bio-reactors for designed experiments in the Cell Culture Lab
- Calibrate pH and Do probes using buffer solution
- Passage cell culture shake flasks with media under Fume Hood using aseptic technique
- Sample reactors/wave bags as needed using Cedex, Nova, YSI, BGA equipment
- Operational Excellence projects
Education
Bachelor of Science - Business Administration
University of Rhode Island
Kingston, RI08-2005
Bachelor of Arts - Biological Sciences
University of Rhode Island
Kingston, RI08.2005
Attended -
IPAG University
Nice, France01.2004
Attended -
Salve Regina University
Newport01.2000
Skills
- Immunoassay
- Gel electrophoresis
- HPLC/HPLC
- UV concentration
- Polysorbate liquid and solid phase extractions
- FTIR techniques
- Optical microscopy
- Scanning Electron Microscope
- UV spectrophotometer
- Laboratory Information Management System
- Empower Chromatography Data System
- Softmax Pro Software
- Biovia electronic laboratory notebook system
Instrumentation
- FTIR techniques and optical microscopy
- Scanning Electron Microscope
- UV spectrophotometer
Attributes
- Excellent communication and organizational skills
- Ambitious
- Hardworking
- Team player
- Detail oriented
Timeline
Sr. Scientist Attribute Sciences
Amgen
07.2023 - Current
Scientist, Attribute Sciences
Amgen
09.2021 - 07.2023
Sr. Associate Scientist, Attribute Sciences
Amgen
04.2019 - 09.2021
Associate Scientist, Attribute Sciences
Amgen
06.2017 - 04.2019
Senior Associate Attribute Sciences
Amgen
03.2013 - 07.2017
Associate Attribute Sciences
Amgen
06.2010 - 03.2013
TWA-Process Development Cell Sciences
10.2009 - 06.2010
Bachelor of Arts - Biological Sciences
University of Rhode Island
Bachelor of Science - Business Administration
University of Rhode Island
Attended -
IPAG University
Attended -
Salve Regina University
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