Erin K. Abbott
New Woodstock,NY
Summary
Results-driven Principal Scientist specializing in bioreactor process development and scale-down modeling. Led cross-functional teams to enhance project outcomes through innovative process characterization and validation. Expertise in DeltaV software and talent development, contributing to operational improvements in manufacturing sciences.
Overview
25
25
years of professional experience
Work History
Principal Scientist, Upstream Manufacturing Sciences and Technology/Process Development
LOTTE BIOLOGICS USA, LLC
Syracuse, N
08.2024 - Current
- Leads design, execution, and analysis of scale-down model cell culture studies in shake flasks, AMBR 250, cell bag bioreactors, various sized glass seed and production bioreactors, 50-L SUB, and primary recovery laboratory studies for process development, process characterization, process validation, and developed process control strategies
- Lead technical transfers from laboratory-scale or pilot-scale to manufacturing-scale, as well as process troubleshooting utilizing representative scale-down models.
- Led risk assessments using FMEA and other tools to establish design space and study designs for laboratory experiments.
- Collaborated with cross-functional teams to provide targeted process technical support, enhancing project outcomes.
- Author and review upstream documentation to capture experimental designs and results via protocols and other associated scientific documents
- Interact with global Health Authorities for site inspections and CMC review and lead authoring of regulatory filings (IND, IND amendment, BLA, MAA, PAS, etc.) and inquiry responses
- Trains, supervises and develops key talent.
Associate Director, Manufacturing Sciences and Technology/Process Development
LOTTE BIOLOGICS USA, LLC
Syracuse, NY
01.2023 - 08.2024
- Led a team of 15 scientists for Upstream and Downstream
- Provided scientific leadership for experimental design and analysis of results, including preparation and approval of study designs, protocols, data presentations, final reports, and technical documents
- Supported technology transfer of processes into laboratory and manufacturing space; provided process-related troubleshooting at laboratory and manufacturing scale through effective study designs and scale-down studies
- Establishes project priorities, timelines, and resource allocation
- Developed and implemented departmental procedures and practices; prepared and executed laboratory capital and staffing plans
- Trains and supervises staff, develops key talent, establishes and maintains well -established succession plans
- Collaborates with cross-functional site teams and representative from other functional groups outside of Manufacturing Sciences and Technology
- Interacts with global health authorities for site inspections, site tours, and support of CMC regulatory submissions
Associate Director, Manufacturing Sciences and Technology
Bristol-Myers Squibb
Syracuse, NY
03.2022 - 01.2023
- Led a team of 12 scientists for Upstream and Downstream
- Provided scientific leadership for experimental design and analysis, preparing and approving study designs, protocols, data presentations, final reports, and technical documents to ensure compliance and quality
- Supported technology transfer of processes into the laboratory and manufacturing space internally and externally. Provided process-related troubleshooting at laboratory and manufacturing scale through effective study designs and scale-down studies.
- Developed and implemented departmental procedures and practices, preparing and executing laboratory capital and staffing plans to enhance operational efficiency
- Establishes project priorities, timelines, and resource allocation
- Trains and supervises staff, develops key talent, establishes and maintains well -established succession plans
- Interacted with global health authorities during site inspections and tours, supporting CMC regulatory submissions to facilitate successful regulatory outcomes
- Collaborates with cross functional site teams and a representative from other functional groups outside of Manufacturing Sciences and Technology
Senior Manager, Manufacturing Sciences and Technology - Upstream
Bristol-Myers Squibb
Syracuse, NY
08.2021 - 03.2022
- Manage a team of 3 scientists
- Led cross functional teams
- Served as a Subject Matter Expert on several projects
- Authored, reviewed, and revised Health Authority submissions for multiple agencies
- Participated in Health Authority inspections for multiple agencies
- Authored responses to Health Authority inquiries for multiple agencies
- Authored and reviewed technical reports, Standard Operating Procedures, and critical documentation to ensure compliance and operational clarity
- Facilitated alignment between MS&T and other site functional areas
- Facilitated site-wide awareness of group projects to enhance collaboration and support
- Mentored, coached, and trained members of the team
- Support and technology transfer to CDMOs
Manager/Scientist II, Manufacturing Sciences and Technology - Upstream
Bristol-Myers Squibb
04.2020 - 08.2021
Scientist I, Manufacturing Sciences and Technology - Upstream
Bristol-Myers Squibb
06.2016 - 04.2020
- Led the design and execution of process optimization, investigation, and characterization studies in 5-L Finesse and Sartorius bioreactors of mammalian cell lines in support of commercial manufacturing
- Managed internal and external technology transfers of different processes
- Contributed to characterization and use testing of raw materials and consumables for commercial manufacturing, ensuring compliance and quality standards
- Utilized statistical analysis software and Microsoft Office tools to present small-scale and manufacturing-scale data to diverse audiences
- Authored, reviewed, and revised submissions to Health Authorities for multiple agencies, facilitating regulatory approval processes
- Engaged in Health Authority inspections for multiple agencies
- Authored and reviewed technical reports, Standard Operating Procedures, In-Process Control documents, and Master Batch Records
- Acted as a Subject Matter Expert on several projects
- Led cross functional teams
- Mentored, coached, and trained members of the team
Associate Scientist II, Manufacturing Sciences and Technology - Upstream
Bristol-Myers Squibb
08.2013 - 06.2016
- Executed process optimization, investigation, and characterization studies in 5-L Finesse, 5-L Sartorius, and 7-L Sartorius bioreactors in support of commercial manufacturing.
- Supported technology transfer teams by facilitating knowledge transfer and ensuring alignment with project goals
- Delivered expert guidance on specialized topics in technology transfer, enhancing team understanding and execution of complex processes.
- Authored comprehensive responses to Health Authority inquiries, addressing compliance and regulatory requirements from multiple agencies
- Authored and revised Standard Operating Procedures
- Authored technical reports and memos
- Trained members of the team
Associate Scientist I and Associate Scientist II, Process Development - Upstream
Bristol-Myers Squibb
10.2007 - 08.2013
Lab consultant, Process Development - Upstream
Bristol-Myers Squibb
05.2006 - 10.2007
- Executed process development studies for manufacturing processes in 7-L Sartorius, 5-L Braun, 1-L Dasgip, and 20-L Applikon bioreactors and shake flasks.
- Conducted investigation studies, providing critical insights to optimize the commercial manufacturing process.
- Expanded inoculum in T-flasks, shake flasks, and wave bags, facilitating collaborative efforts across multiple labs.
- Prepared media for multiple labs.
- Entered data into Excel spreadsheets for accurate record keeping.
- Authored work instructions for other team members
- Trained new employees and consultants in accordance with SOPs and best practices
- Represented the team on the Laboratory Safety and Health Committee.
Assistant Scientist II, Transfectoma Development
Medarex
Bloomsbury, NJ
07.2004 - 04.2006
- Performed transfection via electroporation
- Colony selection from 96 well plates
- Maintenance and culturing of Mammalian cell lines in shaker flasks and spinner flasks
- Performed Single Cell Cloning using limiting dilution techniques
- Cryopreserved and thawed cell lines to ensure viability for ongoing experiments
- Selected specific cell clones for further research and development.
- Experienced using plates and T-flasks
- Conducted Elisa assays to evaluate clone productivity and identify optimal candidates for development
- Introduced Wave bag system to streamline generation of reference material for research
Assistant Scientist I
Medarex
07.2001 - 07.2004
- Cultivated and maintained mammalian cell lines in spinners under cGMP conditions to support research and production needs
- Executed media preparation tasks following established cGMP protocols to support cell culture needs. according to established cGMP procedures
- Executed cGMP documentation in accordance with Standard Operating Procedures and Master Batch Records to ensure compliance and traceability
- Executed sterile gowning procedures to maintain contamination-free environments in compliance with cGMP standards, according to cGMP procedures
- Conducted regular maintenance on equipment to ensure optimal performance and longevity. to maximize operational efficiency and reliability.
Education
Bachelors of Science - Biology
William Paterson University of New Jersey
Wayne, NJ01-2001
Skills
- Scale-down modeling
- Bioreactor process development
- Process characterization
- Process validation
- Automation system knowledge
- Electronic lab notebook
- Regulatory compliance systems
- Manufacturing resource planning
- Microsoft Office Suite expertise
Timeline
Principal Scientist, Upstream Manufacturing Sciences and Technology/Process Development
LOTTE BIOLOGICS USA, LLC
08.2024 - Current
Associate Director, Manufacturing Sciences and Technology/Process Development
LOTTE BIOLOGICS USA, LLC
01.2023 - 08.2024
Associate Director, Manufacturing Sciences and Technology
Bristol-Myers Squibb
03.2022 - 01.2023
Senior Manager, Manufacturing Sciences and Technology - Upstream
Bristol-Myers Squibb
08.2021 - 03.2022
Manager/Scientist II, Manufacturing Sciences and Technology - Upstream
Bristol-Myers Squibb
04.2020 - 08.2021
Scientist I, Manufacturing Sciences and Technology - Upstream
Bristol-Myers Squibb
06.2016 - 04.2020
Associate Scientist II, Manufacturing Sciences and Technology - Upstream
Bristol-Myers Squibb
08.2013 - 06.2016
Associate Scientist I and Associate Scientist II, Process Development - Upstream
Bristol-Myers Squibb
10.2007 - 08.2013
Lab consultant, Process Development - Upstream
Bristol-Myers Squibb
05.2006 - 10.2007
Assistant Scientist II, Transfectoma Development
Medarex
07.2004 - 04.2006
Assistant Scientist I
Medarex
07.2001 - 07.2004
Bachelors of Science - Biology
William Paterson University of New Jersey