Aquilla E Scott
Patterson,CA
Summary
Sharp and focused professional offering skills in a GMP, GLP, GDP, Tech Transfer, Quality Assurance, Quality Control and Downstream processing. Determined and well-rounded individual with more than 15 years experience in the biotech industry having worked with start-up and large sized companies.
Overview
23
23
years of professional experience
Work History
Associate Scientist
Tenaya Therapeutics
01.2022 - Current
- Followed and maintained quality assurance standards in the biotechnology industry.
- Development and scale up SME of purification unit operations using chromatography and various filtration methods for Gene Therapy products.
- Provide technical support for ongoing manufacturing downstream processes including critical information.
- High throughput production and characterization techniques.
- Conducted experiments in laboratory environments for product development purposes.
- Documented all processes during experiments, keeping meticulous notes of changes that were unexpected.
- Trained newly hired employees on processes and procedures relevant to lab tasks at hand.
- Worked with cross-functional project teams to support productions of assay work (SDS-PAGE, capsid titer ELISA) with the Analytical Development team.
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
- Read literature related to scientific area of expertise to remain current in knowledge of gene therapy products.
- Conducted experiments in laboratory environment for product development purposes in purifying various cell culture systems.
Lead Manufacturing Associate
IGM Biosciences
12.2019 - 12.2020
- Reviewer of IOQ binders and documentation for various equipment of a GMP Facility.
- Proficient in authoring and rapid reviews of standard operating procedures and batch production records.
- Knowledge of 21CFR Part 11 compliance guidelines and responsibilities.
- Supported documentation readiness required for facility release to begin GMP production.
- Supported new production facility start-up by authoring IOQ and other GMP process documents.
- Coordinated lesson plans with field engineers and training teams.
- Excellent with team projects, demonstrating an ability to work collaboratively and effectively.
- Developed and maintained courteous and effective working relationships.
- SME of single use technology for downstream protein purification processes.
- UNICORN recipe creation for AKTA systems.
MSAT Scientist
Lonza Pharma And Biotechnology
01.2011 - 10.2017
- Responsible for conducting training sessions to quality assurance and manufacturing associates on platform projects and processes.
- Responsible for authoring standard operation procedures (SOP's) process descriptions.
- Experience in CAPAs and change controls.
- MSAT Lead and primary customer contact for processes produced and demonstrated in the GMP facility.
- Presented information about specific projects to internal partners and customers.
- Supported and cross-functionally collaborated with manufacturing, quality control, quality assurance and supply chain stakeholders.
- SME of monoclonal antibody purification processes scale-up and tech transfers.
- Provided on floor downstream support for Phase I and II GMP clinical manufacturing of monoclonal antibodies.
- Experience with authoring of New Product Introduction (NPIs) and various reports for scaling new processes.
Research Associate III
Baxalta US Inc
07.2015 - 09.2017
- Support of clinical manufacturing during technical transfer for various projects.
- Support of analytical group with various testing and reporting out data for tests run on each project.
- SME for UNICORN recipe creation for AKTA purification platform systems.
- Laboratory lead for small-scale protein purification experiments.
- Set up equipment, organized inventory and maintained facilities.
- Produced actionable information that improved the process development lab.
- Developed data collection strategies and monitored data quality for optimal research results.
Research Associate II
Baxter BioScience
06.2011 - 06.2015
- Requested or acquired equipment or supplies necessary for projects.
- Proactively addressed challenges of initiating a purification process working as an independent contributor and within a team environment.
- Performed technical transfers from small scale process models designed by process development teams to manufacturing scale in a GMP manufacturing suite.
- Working knowledge of Unicorn Software on the AKTA purification systems.
Research Associate I
Baxter BioScience
10.2007 - 06.2011
- Working knowledge of Unicorn Software on AKTA purification systems.
- Knowledge of method/recipe authoring for Unicorn system.
- Exercised diligence and strong work ethic to quickly learn a 20 step process in 3 days; achieved top candidacy for a permanent position.
- Executed and developed small-scale purification processes for proteins and therapeutic antibodies.
- Maintained laboratory notebooks giving strong recognition to detail.
- Communicated with manufacturing and analytical groups to conduct investigations and troubleshoot challenges with the process.
- Working knowledge of SDS-PAGE, Western Blotting and some ELISA's.
Clinical Production Technician
Berlex Biosciences
01.2001 - 03.2007
- Environmental Monitoring (EM) testing of gowning procedures for entry into the GMP facility.
- Buffer/media prep for downstream and upstream processes in a GMP Setting.
- Calibrated machines to maintain required productivity levels and adherence to quality standards.
- Inspected finished products for quality and adherence to quality standards.
- Promptly documented and reported all defective equipment and hazardous conditions.
- Performed setup of Tangential Flow Filtration (TFF) production equipment to establish optimal performance.
- Trained and supervised production personnel to properly use production equipment and apply best practices.
- Inspected equipment and systems to identify issues, immediately reporting problems to repair technicians.
Education
Master of Science - Healthcare Administration
California State University - East Bay
Hayward, CA2010
Bachelor of Science - General Biology
Alabama State University
Montgomery, AL2000
Skills
- GMP, GDP and GLP Documentation
- Deviation investigation and CAPA implementation
- Standard Operating Procedure Development
- Raw material specification and Lab Equipment Calibration
- Single Use Technology Experience
- AKTA Unicorn Software
Timeline
Associate Scientist
Tenaya Therapeutics
01.2022 - Current
Lead Manufacturing Associate
IGM Biosciences
12.2019 - 12.2020
Research Associate III
Baxalta US Inc
07.2015 - 09.2017
Research Associate II
Baxter BioScience
06.2011 - 06.2015
MSAT Scientist
Lonza Pharma And Biotechnology
01.2011 - 10.2017
Research Associate I
Baxter BioScience
10.2007 - 06.2011
Clinical Production Technician
Berlex Biosciences
01.2001 - 03.2007
Master of Science - Healthcare Administration
California State University - East Bay
Bachelor of Science - General Biology
Alabama State University