Hired to oversee process and analytical development of lentiviral and retroviral vectors.Developed a novel manufacturing process in one year for lentiviral vectors using suspension cell line in serum-free medium.Functioned as the technical lead for GMP production of lentiviral vectors and plasmid DNA at CMOs.

Led process development for manufacturing of lentivirus vectors in suspension cell cultureGuided assay development to support process development for lentiviral vectorsManaged CMO for GMP vector production and T cell processingDirected research vector core, providing lentiviral, retroviral and AAV vectors for Kite Pharma

The company was acquired by Gilead/Kite.

Developed process for manufacturing of lentivirus vectors in suspension cell cultureLead development of stable packaging and producer cell lines for lentiviral vectors productionProvided support for CAR-T cell product manufacturing process development Directed assay development to support process development for lentiviral vectorsParticipated in non-viral vector development for gene editing (CRISPR/Cas9)

Lead process development and GMP manufacturing of lentiviral vectors.

 Founded Biotech Experts as a consulting company in order to accelerate development of new biological therapies for life-threatening diseases through providing expert services to the biotech community. Signed consulting agreements with several companies, including Omnia Biologics (see press-release at http://biotechexperts.net/news.aspx). Provided advice in process development for clinical manufacturing of lentiviral and AAV vectors.

Reporting to CEO, supervised adenovirus vectors and stable cell lines manufacturing for high throughput assays. Set up manufacturing and QC laboratories, including facility, equipment, and staff.Led process development for manufacturing of adenovirus vectors and stable lentivirus-transduced cell lines at commercial scale.Directed QC assay development, qualification and validation.Responsible for the review and approval of SOPs, forms, protocols and reports.

Vice President of Operations (2006-2007)Reported to CEO, lead the design, evaluation, and development of systems to produce lentivirus vectors, including the cell culture, purification and analytical characterization of these vectors.Served as a liaison between the Company and facility construction engineer for the 10,000 sq. ft. facility build-up. Two class 10,000 clean rooms were built-in within the office building.Led process development for manufacturing of lentiviral vectors using stable producer cell line cultured in bioreactors at scale needed for phase III clinical trials (up to 1000 L).Directed assay development, qualification and validation. All (100%) of critical assays were qualified Optimized processing of patient T cells. About 50 patients were successfully treated with VRX496-modified T cell product in phase II clinical trials.Senior Director of Operations (2004-2006)Was responsible for manufacturing of VRX496-transduced autologous T cell product for HIV-infected patients. (No product failures due to manufacturing errors).Directed clinical grade lentiviral vector production for phase II clinical studies in adherence to cGMP’s. (90% success rate).Director of Vector Production (2001-2004)Has been responsible for manufacturing of clinical grade lentiviral vector for clinical studies in adherence to cGMP’s. Successful production of several clinical lots of the vector allowed VIRxSYS to accomplish phase I clinical trials.Production Manager (2000-2001)Responsible for process development of clinical grade lentiviral vector manufacturing. Manufacturing process was successfully developed.Senior Scientist (1999-2000)Responsible for a development of a transient transfection production method for lentiviral vectors.

Responsible for retrovirus vector production for the University.* Maintained and developed retrovirus vector producer cell lines.* Investigated possible use of envelope proteins from different viruses to pseudotype retrovirus vectors.

Responsible for development of new liposomes for the delivery of DNA and chemotherapeutics into cells.* Developed novel sterically stabilized pH-sensitive liposomes for the delivery of drugs in vivo.* Prepared and investigated different cationic liposomes for efficient transfection of primary human cells.