Lead Product Compliance Scientist

• Apr 2016 - Present

Product Compliance Scientist

• May 2015 - Apr 2016

Senior Manager Quality Assurance & Technical Services

• Aug 2010 - Feb 2015

Conduct QA compliance audits of products and processes. Direct and coordinate compliance with all applicable standards and other applicable customer requirements. Ensure that all personnel are trained to perform their jobs effectively. Establish the overall requirements for QA specifications and standards for materials, processes and finished products. Review product and process non-conformance and recommend remedial actions including but not limited to modifications of processes, products or QA standards where warranted. Develop QA plans and other required process control procedures to insure processes, work in progress and finished goods meet the specified quality and cGMP standards. Show less

Manager, Manufacturing Operations Cell Production

• Oct 1995 - Feb 2010

LONZA WALKERSVILLE, INC. / CAMBREX, INC/Poietics: Manager, Poietics Cell Production/ Hepatocytes Cell Production / Cells on Demand Managed direct reports over two/split shifts; completed annual merit reviews, set and achieved individual and team goals aligned with corporate initiatives and departmental directives; budgets; hands on manager; provided technical guidance; set production schedules based upon forecasted sales, actual sales, and inventory levels; product timelines included same day, 24 hour, and spanned several weeks; chaired monthly team meetings and weekly lab meetings; conducted market research, perform cost analysis, created Bills of Materials (BOM), label formats, Quality Assurance Control Sheets (QACS), Device Master Records (DMR), Device History Records (DHR), and Standard Operating Procedures (SOP); completed deviations, Corrective and Preventative Actions (CAPA), attended Material Review Board (MRB); provided technical support to customers and managed customers’ orders working closely with sales and marketing; facilitated Pre-Production Quality Assurance (PQA) for new products; Participated in New Product Introductions (NPI); R&D; tissue acquisition. •Cell isolation and cell culture include hematopoietic stem cells, CD34+, CD133+, T cells, B cells, NK cells, monocytes, dendritic cells, hepatocytes, mesenchymal stem cells, pre–adipocytes, neural progenitors, stromal cells, NPC’s, adipose derived stem cells, osteoclast precursors, and erythroid progenitors. Show less

Lab Manager

• Oct 1995 - Dec 1998

•Instrumental in the launch of the company and its subsequent success. •Coordinated all aspects of laboratory procedures and services. •Coordinated the scheduling of cord blood and fetal liver procurement and processing and involved with tissue acquisition •Provided technical support to clientele; gained exposure to sales and marketing. •Purified CD34+ progenitors and other hematopoietic cell types from cord blood, fetal liver, and bone marrow. •Isolated T cells and various subsets from cord blood, peripheral blood, and bone marrow. •Colony assays and hematopoietic assays, lineage Marker Assays (ELISA). •Screened compounds in vitro and assessed proliferative and differentiative effects upon progenitor cells. •Developed laboratory standard operating procedures Show less

Research Associate II

• 1992 - 1995

•Collected and purified CD34+ progenitor cells from cord blood, fetal liver, bone marrow, and peripheral blood. •Hematopoietic Assays; Developed methods to direct lineage differentiation and proliferation. •Screened compounds in vitro and assessed proliferative and differentiative effects upon human progenitor cells. •ELISA’s (cytokine production and lineage marker) and MTT assays, Immunofluorescence staining of cells for flow cytometry. •Developed and produced monoclonal antibodies. •Served as alternate chairperson and member of the animal care and use committee Show less

Sr. Research Technician

• 1990 - 1992

ADVANCE BIOSCIENCE LABORATORIES: Sr. Research Technician 1990-1992 •Involved in all aspects of the development, production, purification, characterization, and cryopreservation of monoclonal antibodies. Characterization techniques of monoclonal antibodies included protein gels, western blots, Dot Blots, ELISA’s, and immunoprecipitations. Produced virus and viral proteins utilizing the Baculovirus system. ADVANCE BIOSCIENCE LABORATORIES: Sr. Research Technician 1990-1992 •Involved in all aspects of the development, production, purification, characterization, and cryopreservation of monoclonal antibodies. Characterization techniques of monoclonal antibodies included protein gels, western blots, Dot Blots, ELISA’s, and immunoprecipitations. Produced virus and viral proteins utilizing the Baculovirus system.

Research Technician

• 1989 - 1990

•Developed and produced monoclonal antibodies. Characterized monoclonal antibodies utilizing ELISA and Dot blotting techniques. Performed HPLC purification, concentration, and protein estimation of monoclonal antibodies. •Managed all aspects of the animal facility (mice, rats, hamsters). •Developed and produced monoclonal antibodies. Characterized monoclonal antibodies utilizing ELISA and Dot blotting techniques. Performed HPLC purification, concentration, and protein estimation of monoclonal antibodies. •Managed all aspects of the animal facility (mice, rats, hamsters).

Research Assistant

• 1987 - 1989

•In vivo and in vitro drug screening assays; Immunological assays included: natural killer, blastogenesis, IL-1 and IL-2 production, interferon production, cell stimulating factor, and cytotoxicity. Co-managed the animal facility (mice and rats). •In vivo and in vitro drug screening assays; Immunological assays included: natural killer, blastogenesis, IL-1 and IL-2 production, interferon production, cell stimulating factor, and cytotoxicity. Co-managed the animal facility (mice and rats).

Lead Biological/Animal Technician

• 1986 - 1987

•Coordinated in vivo cytogenetic studies including chromosomal aberration, sister chromatid exchanges, micronucleus assays, cell cycle kinetics, dominant lethal assays, and LD50. Produced S-9 product and performed quality control assays, bone marrow harvest and preparation, surgical subcutaneous implants, chromosomal preparation, slide smears and staining. •Managed the genetic toxicology portion of the animal facility (mice, rats, hamsters). Supervised and trained lower level personnel in SOP’s and GLP’s. Show less

Biological Lab Technician II

• 1984 - 1986

PROGRAM RESOURCES, Inc.: Biological Laboratory Technician II, 1984-1986 •Established, maintained and cryopreserved in vivo and in vitro human and murine tumor cell lines from cryopreserved lines and fresh resections. Performed various tumor genetic studies including cell titrations, immunological studies, drug dose response, and developed in vivo metastatic models. PROGRAM RESOURCES, Inc.: Biological Laboratory Technician II, 1984-1986 •Established, maintained and cryopreserved in vivo and in vitro human and murine tumor cell lines from cryopreserved lines and fresh resections. Performed various tumor genetic studies including cell titrations, immunological studies, drug dose response, and developed in vivo metastatic models.