Aseptic processing of lipoaspirated adipose for the generation of stem cells. Cultured stem cells to achieve prescribed dosage for autologous use. Generate and revise SOPS and batch records. Part of the Risk Analysis Assessment team created to bring previously non functioning cleanroom suites and associated systems into compliance. Serve as SME for mfg processes. Mentor and train junior associates.

Upstream manufacturing of biosimilars. CIP and COP of stainless steel equipment, mixers, and tanks. Culturing of CHO and Ecoli cells.

Perform aseptic cell culture activities of iPSC, iNK, and iCD34 cell line such as cell thaws, passaging, expansion, cell differentiation, and harvests in a clean room environment. Completed deviations and CAPAs. Participated in the revising and creation of batch records and SOPs. Maintain cleanroom to be in a constant state of inspection readiness.

Generated human dermal fibroblasts (thaws, cell passages, and harvests in smooth surface roller bottles) for use in downstream processing for the generation of Dermagraft, a cell based living bandaid for the treatment of diabetic foot ulcers.

Preparation of serum and non-serum containing media. Expansion of fibroblasts in roller bottles then 3L bioreactor. Maintenance of 10L reactors. Collection, clarification, concentration, sterile filtration, and filling of cell conditioned media.

Supervised the production of ELAD, a bio-artificial liver derived from human liver cells for the treatment of acute alcohol poisoning. Monitored and trouble-shooted the semi-automated bioreactor systems; CP3000 AND 4800. Performed mammalian cell culture, media preparation, building and sterilization of tubing assemblies all while gowned in class 10,000 cleanrooms. Trained and mentored new hires. Revised/generated SOPs and batch records. Addressed CAPAs, deviations and NCMRs.

Supervised the Clinical Production of hair stimulating complex (HSC), develop and implement procedures and records integral to the production of HSC, and ensure regulatory compliance through proper training and adherence to established procedures. Optimized production using 10L bio-reactors to maximize product volume.

My core responsibility was the optimization of extra-cellular matrix (ECM) and cell-conditioned media (CCM) from research to pre-production via micro-carrier beads in 3L bioreactors. Additional responsibilities include serum and serum free media preparation, bioreactor assembly, autoclaving, ordering supplies, aseptic processing, and all phases of cell culture: thawing cells, passages, cell counting, seeding, and harvesting. Tracked and recorded the stages of cell development, cell doubling times, and ECM development. Performed data analysis to determine optimum feed rates for cultures.

Perform manufacturing tasks as an operator and/or verifier in the production of human mesenchymal stem cells (hMSC) and other cell related cell lines including; media preparation, cell seeding, media change, harvest, aliqouting and freezing of intermediate and final product. Also process fetal specimens for the collection and growth of fetal fibroblasts.

Optimized extra-cellular matrix (ECM) and cell-conditioned media (CCM) from research to pre-production via micro-carrier beads in 1L and 3L bioreactors. Additional responsibilities include serum and serum free media preparation, bioreactor assembly, autoclaving, ordering supplies, aseptic processing, and all phases of cell culture: thawing cells, passages, cell counting, seeding, and harvesting. Tracked and recorded the stages of cell development, cell doubling times, and ECM development with MS Excel and Word. Performed data analysis to determine optimum feed rates for cultures.