Alexandra J Chandler
Newberry,FL
Summary
A versatile and hardworking manufacturing professional, consistently focused on achieving results and demonstrating self-motivation. Possessing extensive experience in manufacturing processes, team communication, quality systems, and fostering organizational teamwork within the pharmaceutical industry.
Overview
10
10
years of professional experience
Work History
Manufacturing Associate II
Kincell Bio
Gainesville, FL
01.2025 - Current
- Authored, reviewed, and maintained GMP documentation, including MBRs, SOPs, work instructions, and material specifications
- Train colleagues on GMP protocols, performance, and equipment usage
- Performed cell count and viability testing using Cellometer K2 and NC-202 systems
- Executed cell transfection and transduction processes
- Conducted cell processing using GatheRex, Rotea, Prodigy, MaxCyte, and Zip Thaw systems
- Reviewed and verified process logbooks to ensure documentation accuracy and compliance
- Created purchase requests and coordinated procurement of materials and supplies
- Escorted vendors and visitors in accordance with cleanroom and GMP requirements
- Performed post-campaign line and area clearance to maintain readiness and compliance
- Supported autologous and allogeneic cell therapy manufacturing in a GMP environment
Specialist II
National Resilience, Inc
Alachua, FL
01.2021 - 01.2025
- Perform chromatographic purification via programming, set-up, and utilization of AKTA Ready, AKTA XL
- Perform UF/DF techniques using Sartorius Flex Act, Sartopore, Repligen KR2i/KMPi/KTF systems
- Perform in sterile environment using aseptic manipulations in BSC during downstream processing
- Possess a full understanding and experience with downstream techniques and equipment, including clarification, bulk filtration, viral filtration, and buffer/media preparation
- Perform clarification, bulk filtration, viral filtration, buffer/media preparation, BOM preparation and verification, and cross-functional collaboration
- Compose and review GMP documentation including MBRs, SOPs, work instructions, and material specifications
- Train colleagues on GMP protocols, performance, and equipment usage
- Contributed to technical reviews, investigations, and process improvement projects
- Performed qualifications/trainings on VANRX for fill finish and assisted in preparing, crimping, fill, and stoppering
- Streamlined task times by setting specific personal schedules for tasks
- Conducted qualifications and training for VEEVA vault to perform and write deviations for minors and major deviations
- Optimizing the growth and productivity of cell or microbial cultures
- Controlled growth conditions such as temperature, pH, dissolved oxygen, and nutrient supply to achieve optimal cell growth and protein expression for adherent and suspension cells
- Performed upstream processing using small scale Bioreactors, Univercells, and iCELLis 500
Manufacturing Technician
Takeda Pharmaceutical Company
Social Circle, GA
01.2019 - 01.2021
- Complete all daily production functions including training, implementing company expectations, planning, and monitoring personal performance, and performing company policies and procedures
- Upholding quality assurance by adhering to GMP and EH&S standards
- Performing new processes of manufacturing methodologies, identifying faults in processes, and providing ideas for correction, and cooperating with Engineering and Quality departments to resolve equipment, process, and compliance issues
- Streamlined production task times by setting specific personal schedules for tasks, creating higher overall yields in production
- Act as a Delegate; perform in an interim position – performing departmental duties- in their absence of the area Lead
- Serve as an SME; participate in internal and external audits with numerous clients
- Consistently achieve company objectives by participating in technical reviews, investigations, and process improvement projects
- Conducted routine quality inspections to verify compliance with safety and regulatory standards.
Manufacturing Technician
General Mills
Covington, GA
01.2016 - 01.2018
- In consecutive roles, planned, performed, and oversaw numerous inspections and tests for products, outlined manufacturing policies and procedures, and conducted real-time floor production processes, guaranteeing the accurate production compliance to quality, documentation, and SOP standards
- Collaborated with the Production Supervisor, and internal support functions to accomplish tasks, influence positive change, and advance the company by way of consistent validation
- Served as a Subject Matter Expert, to production from manufacturing standpoint
- Acted as a Trainer; in charge of instructing new employees on general production operations
- Functioned as a facilitator from floor to management
- Operated as a Contributor; participated in multi-departmental projects
Education
Associate of Science - Health Sciences
Georgia State University
Covington, GA08.2018
High School Diploma -
Eastside High School
Covington, GA05.2016
Skills
- Regulations: GMP, FDA, GDP
Regulations: GMP, FDA, GDP
Summary of Qualifications
- General Manufacturing
- Internal Auditing
- Safety Regulations
- Technical Support
- Inventory Control
- Project Assistance
- Process Improvement
- Manufacturing Processes
- Problem Solving
- Data Analysis
- Teamwork
- Employee Training & Mentorship
- Time Management
- Interpersonal Skills
- Verbal/Nonverbal Communication
Timeline
Manufacturing Associate II
Kincell Bio
01.2025 - Current
Specialist II
National Resilience, Inc
01.2021 - 01.2025
Manufacturing Technician
Takeda Pharmaceutical Company
01.2019 - 01.2021
Manufacturing Technician
General Mills
01.2016 - 01.2018
Associate of Science - Health Sciences
Georgia State University
High School Diploma -
Eastside High School