Gabriella Mireles Email and Phone Number

• Hands on execute and collaborate on process design laboratory studies to support process development, optimization and characterization and essential process improvements.• Perform hands on work in a cell culture lab and process training for GMP clinical production.• Participate and influence a cross-functional development team to advance CMC activities• Perform process analysis and trend process performance• Develop manufacturing processes for cell therapy products• Design and execute process development studies to develop a thorough understanding of operating and performance parameters• Write and review technical documentation from writing technical SOPs, draft manufacturing batch records, technical reports and summary reports.• Create slides and supporting data to communicate results to senior leadership.• Lead a team through development studies and activities through IND filing.• Ability to meet deadlines for developmental milestones

• Responsible for mammalian cell culture process development to produce recombinant proteins, monoclonal antibodies (mAbs), and antibody drug conjugate (ADC) intermediates. • Media screening, adaptation to suspension, adaptation to serum free, comparing growth and productivity in various media, growing and maintaining cells utilizing aseptic techniques in T-flasks, spinner flasks, and shake flasks.• Worked with many different kinds of mammalian cell lines.• Applied a good understanding of the effect of general metabolic pathways, physical as well as mechanical parameters on cell growth and production.• Operated and troubleshot cell culture equipment such as controllers, bioreactors, and bioprocessing analyzers.• Optimized lab, pilot, and manufacturing scales process for technology transfer to Manufacturing department. • Researched and implemented new methods and technologies to enhance operations. • Clarification filter sizing. Culture media and supplement/feed preparation. • Analyzed growth, production and nutrient usage data. • Excellent documentation of data and findings for traceability and regulatory requirements.• Technical and Summary Report writing.

• Implemented operations relative to the Design of Experiment (DOE) development, optimization, and scale-up of upstream process for large-scale plasmid DNA and protein production in microbial systems including E.coli, yeast, and Corynebacterium glutamicum (Corynex®/ gram positive bacterium).• Installed and setup with working knowledge of the DAGIP GA4 Exhaust Analyzer and CEPA LE Continuous centrifuge• Demonstrated Sartorius Ambr 250 modular system as scale-down model for higher throughput SUF/SUB DOE development and optimization. • Designed and executed performance and cost analysis of Roche Cedex Bio Analyzer• Working knowledge of Sartorius Sartoflow® Smart and Sartoflow® Advanced TFF System

• Developed scalable processes with improved yield and reduced costs for manufacturing systems • Authored technology transfer reports, standard operating procedures (SOPs), and raw material specifications• Evaluated 50L and 300L Thermo Scientific single-use fermentor (SUF) / bioreactor (SUB) as well as GE/Cytiva 50L Xcellerex (XDR-50) systems• Edited, reviewed, and approved master cell bank and fermentation production batch records • Executed host/strain selection and expression system feasibility screening

• Independently planned and executed fermentations, updated clients on process development results, and generated research cell banks (RCBs). • Experienced with the following assays: Qiagen manual Mini/Midi/Maxiprep, Qiagen QIAcube, densitometry using agarose gel electrophoresis, and western blot.• Performed heat/chemical and electroporation (Bio-rad Gene Pulser Xcell System) transformation • Cross trained in cGMP upstream biologics with support in Master Cell Bank (MCB) production, 100L and 1000L Abec fermentor clean in place (CIP), steam in place (SIP), setup, and operated. • Operated and maintained NOVA BioProfile 300B Analyzer.• Experienced with alkaline cell lysis, microfiltration, and ultrafiltration / diafiltration (UF/DF) (flat sheet and hallow fiber)• Trained new personnel and interns in upstream and downstream process development procedures.

• Setup, operated, and maintained autoclavable glass 5L Applikon fermentor and 5-10L New Brunswick Bioflow 3000 fermentor.• Experienced with the following lab equipment: biological safety cabinet, laminar hood, fume hood, pH/ conductivity meter, spectrophotometer, and centrifuge.• Densitometry based on SDS-PAGE analysis.• Lab support for Upstream and Downstream Process Development activities: maintain stockroom, wash glassware, autoclave, depyrogentation oven, biohazard waste disposal, and prepare fermentor / bioreactor components, media, buffers, and other solutions as needed.

• Trained in proactive learning and study strategies, attended lectures, recorded notes, and completed assigned reading for Molecular Biotechnology.• Conducted review sessions for Molecular Biotechnology that helped students integrate course content and learning/study strategies.