Alex Thomas Raynor
Greenville,NC
Summary
Diligent Senior Microbiologist with robust background in microbiological research and managing and coordinating projects for the team. Highly proficient in SOP development, validations/tech transfer, audit leadership, and cross-functional collaboration to ensure compliance and operational efficiency. Proven ability to train and mentor peers and collaborate effectively to achieve operational efficiency. Demonstrated ability to raipdly acquire new skills/knowledge with a strong commitment to continuous learning and professional growth.
Overview
18
18
years of professional experience
Work History
Senior Microbiologist (Level III)
Catalent Pharma
Greenville, NC
01.2020 - Current
- Responsible for overseeing a 150% increase in contract testing for the micro group w/in a 5 year period
- Successfully coordinated and managed projects for new clients and incoming testing for the group, overseeing compliance, prioritization, and on-time delivery
- Supported quality and compliance activities through hands-on use of Trackwise, IntelliLims, SLIM, Master Control, EDMS and others
- Led regulatory audits for the microbiology laboratory, coordinating documentation, responses, and follow-up actions
- Prepared, reviewed, and maintained SOP’s, protocols, risk assessments, validation reports, and deviations to support and ensure compliance; performed Root Cause Analysis & developed CAPA's to ensure compliance
- Served as Quality Assurance liaison/lead reviewer for our group and led group to the highest RFT on site
- Trained/supervised incoming members on responsible curriculum and all methods of analysis
Senior QC Scientist (Level II)
Mayne Pharma, Inc.
Greenville, NC
06.2017 - 01.2020
- Collaborated with clients and project managers to meet deadlines and ensure drugs would be available to patients
- Perform a variety of laboratory tests including, but not limited to, microbial limits test, method validation, USP water testing (bioburden, TOC, conductivity, etc.), environmental monitoring, water activity, sterility/sterility validations, particulate matter, microscopic particle count test, antimicrobial (preservative) effectiveness test, bacterial endotoxin testing (LAL)/BET validations, growth promotion testing of media and agars, and potency assay testing
- Led investigations involving non-compliance, as well as authored and reviewed SOP’s, protocols, validation reports and methods, deviations, etc.
Microbiologist/QC Scientist (Level I)
Metrics, Inc.
Greenville, NC
10.2013 - 06.2017
- Performed a variety of laboratory tests for the micro lab
- Managed spreadsheets to keep track of all of the transactions and stability studies on test
Laboratory Technician
Metrics, Inc.
Greenville, NC
07.2011 - 09.2013
- Perform a variety of laboratory tests including microbial limits test, USP water testing (bioburden, TOC, conductivity, etc.), water activity, sterility, particulate matter, microscopic particle count test, antimicrobial (preservative) effectiveness test, growth promotion testing of media and agar
Delivery/Warehouse
A C Controls
Greenville, NC
09.2007 - 05.2011
- Manage inventory to determine when supplies are needed, check orders and quotes and efficiently organize them, ship orders and receive inventory, deliver inventory to customers, clean warehouse
Education
Bachelor of Science - Biology
East Carolina University
Greenville, NC12.2010
Skills
- Microsoft Office (Word, Excel, PowerPoint, etc)
- Project Coordination/Management & Communication
- Regulatory Compliance & Auditing
- Problem Solving & Strategic Thinking
- QMS & GMP Documentation
- LIMS, Trackwise, Master Control
- Statistical data analysis & interpretation
- Lean/Six Sigma Certified
Timeline
Senior Microbiologist (Level III)
Catalent Pharma
01.2020 - Current
Senior QC Scientist (Level II)
Mayne Pharma, Inc.
06.2017 - 01.2020
Microbiologist/QC Scientist (Level I)
Metrics, Inc.
10.2013 - 06.2017
Laboratory Technician
Metrics, Inc.
07.2011 - 09.2013
Delivery/Warehouse
A C Controls
09.2007 - 05.2011
Bachelor of Science - Biology
East Carolina University
Activities
- Chancellor’s List, Dean’s List, and Honor Roll during various semesters at ECU
- Received Ardee C. and Myra L. Borders Scholarship