• Supported the technical transfer and scale-up of biological processes from process developmentinto biologics/commercial and clinical manufacturing for both drug substance and drug product.• Authored facility fit reports and sample plans for both drug substance and drug product processes while providing training to the manufacturing group on these documents.• Reviewed and approved manufacturing batch records.• Authored manufacturing support SOPs.• Investigated and resolved process deviations, root cause investigations, CAPAs and implemented process improvements.• Conducted CAPA trainings for downstream operations group.• Authored, reviewed and approved change controls and risk assessments. • Reviewed and approved single-use consumable drawings required for the manufacturing facility.• Authored, reviewed, and approved manufacturing bill of materials• Worked with logistics group to forecast and acquire raw materials and consumables for processing.• Coordinated the submission and shipment of samples.• Analyzed data from manufacturing to track performance and optimize future processes.• Composed campaign summary reports• Assisted in drug product vial filling and vial visual inspections.

• Prepare large and small scale buffers and other solutions in disposable and non-disposable systems.• Pack, unpack, and clean Axichrom chromatography columns.• Operate spectrophotometers, autoclave, lancer, scales, and other meters.• Operate AKTA Ready and Process chromatography skids to purify monoclonal antibodies.• Perform Protein A filtration, CEX, and AEX column chromatography steps.• Perform both Viresolve and Planova virus filtration methods. • Utilize Pall Single Use Tangential Flow Filtration skids to concentrate and perform buffer exchange on in process product stream. • Formulate and bulk package drug substance• Routinely use SAP to monitor inventory and manage products that are produced.• Revise SOPs, author new solution and process MBRs and initiate document change requests in DCA.• Participated in Yellow Belt operational excellence and CPR trainings.• Utilize PD LIMS to acquire LIMS numbers and track in process and release samples• Trained in current GXP.• Collaborate with PD and the manufacturing support group in tech transfer meetings. • Trained as lead investigator for high and medium risk deviations.

• On site contact for IT, HR, and accounting departments.• Review national science test items for content.• Score high stakes English proficiency tests. • Write and review items for high stakes English proficiency tests• Manage Tausug language DLPT V item review• Trained in the ILR scale for listening and reading• Coordinate logistics for DLPT V consultant orientation• Recruit interns and place them with SLTI staff on projects that were closely matched to the intern’s skill set.

• Trained in aseptic technique and Good Laboratory Practice Standards• Trained in mammalian cell culture (L929 mouse cells)• Responsible for logging in test articles using Star Lims• Generated reports for companies utilizing IIVS in vitro testing programs• Trained in Bovine Corneal Opacity and Permeability Assay

• Performed quality control tests on HIV-1 Western Blot Kits• Collected data for HIV-1 & 2 rapid test stability study• Trained in HIV BED Incidence Test (Enzyme Immunoassay)