Michael Bain
Goldsboro,NC
Summary
Passion for the manufacturing sector drives a commitment to continuous learning and knowledge sharing. Leveraging expertise to train and mentor colleagues fosters a collaborative environment that enhances team performance. Strong dedication to improving processes and efficiency contributes to overall organizational success. Eager to embrace new challenges and further develop skills within the industry.
Overview
9
9
years of professional experience
Work History
Manufacturing Tech IV (Cell Culture/Fermentation/Gene Therapy)
Fujifilm Biotechnologies
Morrisville
02.2019 - Current
- Managed and led a five-person team in Cell Culture.
- Performed in-process testing (pH, conductivity, visual inspection)
- Maintains training to perform all required manufacturing activities.
- Assists and/or lead cycle counts and manage materials for the assigned manufacturing functional area.
- Performed cell culture sterilization techniques.
- Supports mammalian cell culture manufacturing processes.
- Sustaining purification of bio-pharmaceuticals
- Documenting daily manufacturing operations in a cGMP environment
- Working with single use bioreactors, fermentation, and/or filtration
- Produce pharmaceutical components and products by setting-up, cleaning, operating, and maintaining equipment following aseptic procedures
- Produces requirements by operating and monitoring equipment, observing varying conditions, adjusting equipment controls, calculating concentrations, dilutions, and yields, adhering to aseptic procedures.
- Prepares equipment by performing sterile cleaning-in-place (CIP), servicing-in-place (SIP), and manual cleaning.
- Revised SOPs along with work instructions for old and new processes
Formulation Technician III (Aseptic Operator)
Thermo Fisher Scientific
Greenville, NC
01.2017 - 02.2019
- Ensured pharmaceutical products in manufacturing are in accordance with Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMPs) and other batch related activities.
- Verified and documented production activities in batch records, logbooks, etc.
- Promoted to trainer
- Assisted in troubleshooting operational and production problems to identify appropriate corrective actions.
- Troubleshooted and resolving issues with products and systems.
- Ensured compliance with safety regulations and company policies.
- Attempts to troubleshoot any issues, using technical knowledge.
- Maintained production machines and equipment, cleans equipment, and ensures the work floor is clean, safe, and well maintained.
Education
Bachelor of Science - Industrial Technology with concentration in Bio-Manufacturing and minor in Industrial Management
East Carolina University
Greenville, NC05-2022
Associate of Applied Science - Bioprocess Technology
Johnston Community College
Smithfield, NC05-2016
Skills
- Sampling
- Microsoft Office & Team
- Delta V
- SAP /SOP’s
- Trainer
- Application Launcher
- Access
- Trackwise
- LIMS
- Documentation Review
- Cleanroom/ Gowning
- Electronic Batch Record
- RF Scanner
- Creating logs /CAPA
- CDA/ FDA Regulations
- Team player
- DCS
- Material Quality Inspection
- HIPAA & OSHA trained
- In process checks/ verification
- Quality Control Analysis
- AGV trained
- GDP/ CFR’s
- Team lead
Accomplishments
Promoted to Lead Technician and trainer.
Timeline
Manufacturing Tech IV (Cell Culture/Fermentation/Gene Therapy)
Fujifilm Biotechnologies
02.2019 - Current
Formulation Technician III (Aseptic Operator)
Thermo Fisher Scientific
01.2017 - 02.2019
Bachelor of Science - Industrial Technology with concentration in Bio-Manufacturing and minor in Industrial Management
East Carolina University
Associate of Applied Science - Bioprocess Technology
Johnston Community College