Ashley Williams
Burtonsville
Summary
Dedicated biotechnology professional with over 10 years as a Clinical Laboratory Technician and 5 years as a Certified Pharmacy Technician. Expertise in GLP specimen preparation and strong knowledge of HIPAA regulations. Proven skills in communication, relationship building, and critical thinking, enabling rapid adaptation to new methodologies and the development of effective technical solutions.
Overview
15
15
years of professional experience
Work History
Senior Biopharmaceutical Associate
Human Genome Sciences, Inc
Rockville
06.2023 - Current
- Monitored processes to ensure product quality and optimize manufacturing throughput for Benlysta and Nucala.
- Collaborated with upstream teams to troubleshoot process deviations and implement corrective actions, reducing downtime.
- Participated in process improvement initiatives, suggesting modifications to optimize cell culture conditions and media formulations.
- Executed batch records per GMP and site quality standards.
- Supported transfer of upstream processes from development to manufacturing, facilitating equipment qualification activities.
- Operated pharmaceutical manufacturing equipment, including incubators, wave reactors, bioreactors (1.6kl-10kl), and depth filtration skids.
- Maintained compliance with regulations, policies, and procedures for health, safety, and environmental standards.
- Prepared materials and operated production equipment according to established manufacturing practices.
Research and Development Technician
Adaptive Phage Therapeutics
Gaithersburg
06.2019 - 05.2023
- Manufactured and purified bacteriophages on scalable platforms and bioreactors, enhancing production for therapeutic applications.
- Performed experimental work on production, purification, and enumeration of bacteriophage therapeutics.
- Implemented standard operating procedures for phage manufacture and nebulization testing.
- Collaborated with commercial partners to develop phage therapeutics for cystic fibrosis infections.
- Collaborated with cross-functional teams to design and optimize research protocols.
- Prepared progress reports and presented findings to investigators and sponsors, facilitating informed decision-making.
- Supervised undergraduate projects and managed daily research activities, fostering skill development and research continuity.
- Ensured compliance with confidentiality and intellectual property agreements.
Production Technician
Tetracore
Rockville
01.2016 - 05.2019
- Manufactured and shipped Tetracore commercial and contracted products while adhering to USDA, FDA, and cGMP policies for diagnostic reagents and instruments.
- Operated in regulated lab environment, utilizing clean suits to perform complex procedures according to established SOP protocols.
- Executed stringent compliance with regulations, contributing to detection of infectious diseases and bioterrorism threat agents.
- Employed aseptic techniques throughout all laboratory processes to maintain product integrity.
- Collaborated within teams and independently to complete tasks promptly while meeting established quality standards.
- Created and managed shipments alongside inventory tracking for Tetracore products.
- Followed written protocols meticulously, ensuring alignment with industry standards in laboratory practices.
- Ensured high-quality output through effective time management and streamlined operational processes.
Research/Medical Laboratory Technician
Parexel International
Baltimore
01.2011 - 12.2012
- Streamlined GLP lab operations to enhance specimen handling, storage, centrifugation, and shipping processes.
- Executed GLP study-related tasks according to protocol and project specifications to maintain compliance and data integrity.
- Conducted competency training on EKGs, phlebotomy, IVs, and vital signs to ensure staff proficiency during admissions and discharges.
- Achieved promotion from research technician to laboratory technician due to organizational efficiency.
Education
Bachelor of Science - Biotechnology
University of Maryland Global Campus
Hyattsville, MD12-2021
Skills
- Quality control and process optimization
- GMP compliance
- Problem solving
- Protocol design
- Cell culture maintenance
- Microbiological testing
- Aseptic technique
- Data analysis
- Molecular virology
- PCR and ELISA testing
Timeline
Senior Biopharmaceutical Associate
Human Genome Sciences, Inc
06.2023 - Current
Research and Development Technician
Adaptive Phage Therapeutics
06.2019 - 05.2023
Production Technician
Tetracore
01.2016 - 05.2019
Research/Medical Laboratory Technician
Parexel International
01.2011 - 12.2012
Bachelor of Science - Biotechnology
University of Maryland Global Campus