•Provides regulatory support for client submissions to domestic and international healthauthorities.•Serves on panel of auditors for internal GMP audits of various departments.•Conducts Regulatory Assessment of Change controls for impacts to facility, manufacturingprocesses, procedures, and equipment.•Conducts Regulatory Assessment of Vendor Change Notifications for impacts to internal andclient material specifications and validated manufacturing processes.•Generates Annual Product Quality Reviews that cover the manufacturing data associated withthe production of commercial products throughout the evaluation period, including QualityEvents (Deviations, CAPAs, Change Controls, EM Excursions,OOS events), in-process andrelease test data trending for product IPC’s, CPP’s, and CQA’s.•Conducts regular review of regulations and regulatory guidance documents to contribute tothe company's regulatory intelligence program (including 21CFR, ISO, and ICH guidelines).•Maintains regulatory licenses and registrations•Front and back room support during health authority inspections

•Lead all aspects of Upstream Manufacturing including scheduling, material procurement, andhands-on operation in GMP Manufacturing of Phase I and Phase II production•Worked cross-functionally with QA, QC, Facilities, MS&T, and Supply Chain to ensureoperational readiness for manufacturing timeline•Responsible for initiating and managing quality events (Change Control, Deviation, CAPA, andEffectiveness Check)•Responsible for developing and reviewing batch production records, material specifications,SOPs•Served as primary contact for the qualification and procurement of GMP materials•Developed design of experiments to evaluate potential process improvements, subsequent dataanalysis, and presentation of findings•Provided guidance and training for junior team members

•Performed hands-on operations in Upstream Cell Culture including viral infection, viral harvest,cell banking, and cell culture (adherent and suspension)•Assisted with Upstream processes including bioreactor set up, media batching, inoculation, andharvest clarification.•Supported the systematic monitoring of bioreactor parameters such as temperature, cellviability, cell density, pH and other parameters to ensure high product quality.•Performed media preparation to support Upstream processes

•Cell culture: maintained adherent and suspension cell lines, performed viral infection, harvest,and cell banking•Minimal experience with bioreactors including bioreactor set up and batching, inoculation, andclarification•Drafted batch production records, material specifications, and qualified cGMP materials•Generated documents/ workflows in an electronic document management system

-manufactured foot orthotics: fabricated plaster molds for foot orthotics, foot ankle orthotics, above and below the knee sockets, made and modified foot orthotics according to practitioner instructions -logged incoming and outgoing shipments into company database, responsible for ordering materials for the lab/ orthotic devices for patients, maintained lab inventory, and maintained records of vendor, company, and patient transactions

-Preparing and aliquoting solutions for cell culture -Performing mutagenesis and fluoresence assays for identifying and isolating algae mutants within a population for high value metabolite production-Aided in establishing protocol for growth media required for recently isolated Chlorella-like algae