Ashley Souffrant
Baltimore,MD
Summary
Enthusiastic, eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Clear understanding of tasks given and training in work required. Motivated to learn, grow and excel.
Overview
6
6
years of professional experience
Work History
MS&T Engineer III
Catalent Pharma Solutions
Harmans, MD
06.2021 - 06.2024
- Work with GMP manufacturing and Process Development in one or more of the following areas: cell culture, purification and/or fill & finish
- Support client projects as the MS&T Lead for tech transfer of projects from Catalent Process Development and external clients into GMP manufacturing.
- Author tech transfer documents, including detailed process descriptions and scale-up documents
- Author Master Production Records and SOPs to support GMP manufacturing projects
- Working closely with project management to ensure MS&T project milestones are achieved
- Collect and trend process data for external (client) and internal review, and for support of client needs.
- With support of senior staff, draft and/or author technical reports, process tech transfer summary reports, and protocols in support of Tech Transfer and cGMP activities
- Assist with training GMP Manufacturing staff on Client processes
- Serve as team leader for process and product investigations and author investigation reports
- Evaluate and recommend equipment for client projects
- Working well in cross-functional team environment
- Result oriented and efficient
- Strong ability to complete tasks accurately and according to established timelines
- Experience in owning and investigating deviations
- Experience in implementing CAPAs
Manufacturing Associate II
Catalent Pharma Solutions
Harmans, MD
11.2018 - 06.2021
- Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps
- Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs
- Experience with cell culture expansion (centrifugation, filtration)
- Experience in Viral production
- Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays
- Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the person-in-plant (PIP) during manufacturing campaigns
- Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines
- Experience in aseptic processing
Laboratory Research Assistant
The Aslan Research Group
01.2018 - 11.2018
- Investigated how hepatitis C virus impacts the extrinsic and intrinsic pathway of apoptosis in the total peripheral blood mononuclear cell population and in plasmacytoid dendritic cell and natural killer cell subsets
- Investigated the role of pure amygdalin on HepG2 cell proliferation and apoptosis
- Maintenance of suspension and adherent human cells
- Whole cell lysis and protein quantification using the Bradford Assay
- Magnetic-bead isolation of specific cell subsets
- Enzyme-linked immunosorbent assay
Education
Master’s - Public Health Biology
Johns Hopkins University
Baltimore, MD2021
Bachelor of Science - Biology
Morgan State University
Baltimore, MD2018
Skills
- Microsoft Office Suite (ie, Word, Excel, and PowerPoint)
- Technical Documentation
Timeline
MS&T Engineer III
Catalent Pharma Solutions
06.2021 - 06.2024
Manufacturing Associate II
Catalent Pharma Solutions
11.2018 - 06.2021
Laboratory Research Assistant
The Aslan Research Group
01.2018 - 11.2018
Master’s - Public Health Biology
Johns Hopkins University
Bachelor of Science - Biology
Morgan State University