Erin Abbott Email and Phone Number

• Leads design, execution, and analysis of scale-down model cell culture studies in shake flasks, AMBR 250, cell bag bioreactor, various sized glass seed and production bioreactors, 50-L SUB, and primary recovery laboratory studies for process development, process characterization, process validation, and to develop process control strategies• Collaborates with cross-functional teams and provides process technical support• Leads risk assessments using FMEA and other tools, as well as Quality by Design to establish design space and study designs to execute laboratory experiments for development of scalable processes across the process lifecycle• Leads technical transfers from laboratory-scale or pilot-scale to manufacturing-scale, as well as process troubleshooting utilizing representative scale-down models.• Develops process optimization, process robustness initiatives, process troubleshooting, process yield improvements, and process-related investigations through scale-down models• Establishes project priorities, timelines, and resource allocation• Author and review upstream documentation to capture experimental designs and results via protocols and other associated scientific documents.• Documentation of experimental results and presentation to clients• 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.

• Led a team of 15 scientists for Upstream and Downstream• Develops and implements departmental procedures and practices. Prepares and executes laboratory capital and staffing plans• Establishes project priorities, timelines, and resource allocation• Trains and supervises staff, develops key talent, establishes and maintains well -established succession plans• Ensures laboratory maintenance to sustain a safe, effective, and productive environment and ensures that appropriate procedures are followed• Provides scientific leadership for experimental design and analysis of results and preparation and/or approval of study designs, study protocols, data presentations, final reports, and all relevant technical documents• Supports technology transfer of processes into the laboratory and manufacturing space internally and externally. Provide process related troubleshooting at laboratory and manufacturing scale through effective study designs and scale-down studies• Interacts with global health authorities for site inspections, site tours, and support of CMC regulatory submissions• Collaborates with cross functional site teams and representative from other functional groups outside of Manufacturing Sciences and Technology

• Led a team of 12 scientists for Upstream and Downstream• Develops and implements departmental procedures and practices. Prepares and executes laboratory capital and staffing plans• Establishes project priorities, timelines, and resource allocation• Trains and supervises staff, develops key talent, establishes and maintains well -established succession plans• Ensures laboratory maintenance to sustain a safe, effective, and productive environment and ensures that appropriate procedures are followed• Provides scientific leadership for experimental design and analysis of results and preparation and/or approval of study designs, study protocols, data presentations, final reports, and all relevant technical documents• Supports technology transfer of processes into the laboratory and manufacturing space internally and externally. Provide process related troubleshooting at laboratory and manufacturing scale through effective study designs and scale-down studies• Interacts with global health authorities for site inspections, site tours, and support of CMC regulatory submissions• Collaborates with cross functional site teams and representative from other functional groups outside of Manufacturing Sciences and Technology

*Managed a team of 3 scientists*Mentored, coached, and trained members of the team*Authoring of technical documents and responses to health authority inquires*Authoring, reviewing, and revision of Health Authority submissions (CMC) to multiple agencies*Participated in Health Authority inspections as an SME*Led cross functional teams

• Responsible for internal and external technology transfers of different processes• 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• Supported process validation activities performed in manufacturing• Utilized statistically analysis software and Microsoft office tools to create presentations of small-scale and manufacturing-scale data for various audiences• Participated in the raw material and consumable characterization and use testing in support of commercial manufacturing• Authored, reviewed, and revised Health Authority submissions for multiple agencies• Authored responses to Health Authority inquires for multiple agencies• Participated in Health Authority inspections for multiple agencies• Authored and reviewed technical reports, Standard Operating Procedures, In-Process Control documents, and Master Batch Records• Served as a Subject Matter Expert on several projects• Led cross functional teams • Mentored, coached, and trained members of the team• Managed 1 direct report• Participated as an active member of the building evacuation team as a searcher, area coordinator, and door guard•Manufacturing and investigation support

• Responsible for internal and external technology transfers of different processes• 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• Supported process validation activities performed in manufacturing• Utilized statistically analysis software and Microsoft office tools to create presentations of small-scale and manufacturing-scale data for various audiences• Authored responses to Health Authority inquires for multiple agencies• Participated in Health Authority inspections for multiple agencies• Authored and reviewed technical reports, Standard Operating Procedures, In-Process Control documents, and Master Batch Records• Served as a Subject Matter Expert on several projects

Manufacturing Sciences and Technology: Upstream- Responsible for managing all daily operations of 7-L SartoriousBioreactor lab including but not limited to: maintenance of all equipment, scheduling of runs,ordering, medium preparation, cell culture maintenance, and troubleshooting-Technical Writing of Protocols, Final reports, and memos-Study design-Safety

Process Sciences Upstream; Syracuse, New York Associate Scientist II • Responsible for managing all daily operations of 7-L Sartorious Bioreactor lab including but not limited to: maintenance of all equipment, scheduling of runs,ordering, medium preparation, cell culture maintenance, and troubleshooting • Designing and execution of shaker flask experiments • Writing of technical documents such as Development reports and memos • Primary group representative on the Devlims and Symyx electronic notebooking. Responsible for training, role-out, and adoption of the systems. • Served as primary area safety representative • Responsible for 6S in several labsProcess Sciences Upstream; Syracuse, New York Associate Scientist I • Maintenance and culturing of Mammalian cell lines in both shaker flasks and small scale bioreactors • Troubleshooting, ordering of laboratory supplies, and media preparation. • Experience with Bellco control systems, Applikon control systems, and Wave bioreactor control systems. • Experienced in the maintenance and usage of Wescor Vapro Osmometers, Innovatis Cedex Cell Counting equipment , and Nova Bioprofile 400 analyzer. • Responsible for data entry, data and document review, maintaining a proper laboratory notebook, and GMP documentation

Transfectoma Development, Bloomsbury NJAssistant Scientist II• Maintenance and culturing of Mammalian Cell Lines in large and small scale spinner flasks and shaker flasks.• Single Cell Cloning, expansion of best producing cell lines and clones.• Transfections using Electoporation techniques.• Performing cryopreservation and thawing of selected cell lines • Performing Elisa Assay for Antibody and Protein Quantification. • Experienced in the usage of Innovatis Cedex Cell Counting equipment and ViCell Cell Counting Equipment. • Introduced Wave Bioreactor Technology to the lab, and trained lab personnel to properly use it. • Experienced with Writing and following Lab Protocols.• Experienced with Writing Technical Reports for transfer to other groups.• Worked closely with other functional groups as a team.• Adhered to strict timelines. • Maintained a clear and accurate Laboratory Notebook.

Biopharmaceutical Production,Annandale, NJ Assistant Scientist I• Responsibilities included maintaining and cultivating mammalian cell lines.• cGMP record keeping.• Sterile gowning. • Bioreactor experience includes 40L Belco Glass bioreactors and Bioengineering 350L stainless steel and associated controllers. • Maintenance of the bioreactors and the other laboratory equipment .• Experienced with Cell Counting using a Hemocytometer.• Media Preparation.