Greg Pennypacker Email & Phone Number

San Diego, Ca, Us

San Diego, California, Us

• Lead Scientist overseeing a team of five upstream process development associates.• Partnered with the Wellcome Trust to advance development of ZAC3, a cost-effective mAb treatment for Cholera.• Served on the Joint Monitoring and Advisory Group, working with Mapp Biopharmaceuticals and the Coalition for Epidemic Preparedness Innovations (CEPI) to facilitate communications and interactions between both organizations as well as review project activities in terms of timelines and budget as they work to advance a mAb treatment for Nipah virus through manufacturing and clinical trials. • Planned and executed runs to produce GLP Tox material from thaw through final fill.• Design and execute process development studies to establish and scale up mAb production processes utilizing shake flasks and Wave single-use bioreactors.• Perform Fed-Batch and Perfusion studies to evaluate different approaches to mAb production and optimize processes. • Authored, Edited, and Reviewed SOPs and Master Batch Records to establish a quality system.• Utilized quality documents to compile a Tech Transfer package for laboratory and manufacturing processes and equipment utilization.• Utilized and maintained CHO suspension cell lines of various clones at numerous scales.

San Diego, California, Us

• Worked as a member of a cross-functional team to develop a platform manufacturing process to support IND-enabling studies • Performed process development studies to establish and scale up an AAV platform processes utilizing shake flasks, Sartorius AMBR 250, Biostat B-DCU, and Biostat STR200 systems• Organized a Bill of Materials for final scaled up 200L process to project costs, and explore avenues to maximize effective purchasing, timelines, and inventory.• Maintained HEK293 suspension cell line at various scales• Utilized JMP to execute and analyze a DOE to select optimal plasmid ratios in platform process. • Analyzed in-process samples utilizing Vi-Cell Blu, Nova pHOx, and Roche Cedex• Performed ddPCR analysis on samples utilizing Biorad QX200 and QXOne systems• Performed ELISA assays on samples• Authored, Edited, and Reviewed SOPs and Master Batch Records for laboratory and manufacturing processes and equipment utilization.• Performed Tech Transfer of platform process with various CDMOs• Acted as Person In Plant to oversee Tech Transfer and pilot runs on-site at CDMOs • Planned and executed pilot run for new in-house STR200 GLP manufacturing lab• Executed manufacture of 200L GLP lots for Toxicology studies.• Produced in-house working cell bank from master cell bank

Cleveland, Oh, Us

• Managed project to evaluate leachable/extractable risks in GMP process• Managed purchase of GMP grade plasmids and conduct of stability studies of master cell bank and plasmids for GMP AAV production with CDMO• Performed process development studies to improve AAV manufacturing processes utilizing shake flasks, Eppendorf Bioflo 320 H05/H10/H50, Eppendorf DASGIP, and PALL STR-200 reactors.• Wrote SOP's, Master Production Records, and Specs for laboratory and manufacturing processes and equipment utilization. • Designed and executed GMP Aseptic Process Simulations for AAV manufacturing • Performed GMP process lock validation lots for AAV manufacturing in ISO 6 environment • Maintained HEK293 suspension cell lines in shake flasks and bioreactors.• Performed qPCR, ELISA, and SDS Page analysis • Utilized Vi-CELL XR and Vi-CELL MetaFlex instruments to analyze cell cultures• Maintained department inventory tracker/ submit POs for controlled inventory suite• Performed TFF on GMP produced AAV product

Warwick, Us

• Performed Process Development on downstream purification of insulin analogs utilizing reverse phase HPLC and HIC chromatography.• Analyzed protein concentration and purity in purified samples utilizing Waters UPLC and ThermoFisher UHPLC• Conducted Mass Spec analysis on samples utilizing ThermoFisher LC-MS• Maintained and Utilize Tangential Flow Filtration systems• Performed enzymatic digestions of in-process proteins• Maintained CHO cell line at bench scale• Performed Semi-Synthesis reactions• Collaborated on development of activity and solubility assays• Maintained daily notebook of laboratory procedures and data • Maintained the master department production database/inventory log• Authored and organized documents and reports necessary for process Tech-Transfer to CRO • Conducted ELISA assays on insulin analogs

Waltham, Ma, Us

• Performed protein purifications utilizing FPLC (BioRad)• Formulated liquid reagents necessary across all Affymetrix portfolio products varying in volume size from uL-2,600 Lt.• Performed in-process quality analysis on manufactured reagents utilizing tools such as UV-Vis, SDS-Page, pH and conductivity meters, thermocyclers, NanoDrop, etc.• Performed regular equipment validations for both daily use and long-term certification• Wrote, reviewed, and executed Operations Batch Records• Formulated reagents using cGMP in an ISO 13485 environment• Maintained up to date records using JDEdwards software • Followed SOPs and DOPs in daily functions• Applied Lean Tools to maintain a consistent 5S work space • Utilized Good Documentation Practices to maintain lab notebooks and company databases

Santa Clara, California, Us

• Formulated large scale reagents for products for Axiom and CytoScan Dx product lines• Dispensed reagents using cGMP in an ISO 13485 environment• Utilized M&O Perry and Filamatic machines to perform automated product dispensing• Maintained up to date records using JDEdwards software • Followed SOPs and DOPs in daily functions• Applied Lean Tools to maintain a consistent 5S work space • Used Good Documentation Practices

Bachelor Of Science (Cum Laude), Biology

Education record