Product Line Manager

Posted on: 2006-01-24

Tara Lakatos 37 N. Passaic Ave. Apt. 1 Chatham, NJ 07928 973-507-9060 [email protected] EDUCATION: Cedar Crest College, Allentown, PA. Bachelors Degree in Biology received August, 1999. EXPERIENCE: Progenitor Cell Therapy, Hackensack, NJ 8/03-Present Cellular Therapy Specialist/ Product Line Manager This position encompasses all phases of clinical manufacturing of cellular products for therapeutic use. I am involved in the processing and cryopreservation of peripheral blood stem cells, donor leukocytes and bone marrow used for infusion into cancer patients. I am also responsible for a Phase II clinical trial cellular manufacturing for spinal cord injuries using manipulated macrophages, Phase III clinical manufacturing of manipulated antigen presenting dendritic cells for prostate cancer treatment, and Phase I dendritic cell production for a melanoma vaccine. Included in these manufacturing processes I am also responsible for performing QC assays such as endotoxin testing, sterility testing, manual cell counts, trypan blue viability and gram stain. These processes are all under GMP/GTP/ guidelines in class 10,000 and 100,000 clean rooms. Managerial duties include staff scheduling, training staff to SOP's and manufacturing procedures, attending weekly management meetings to report on upcoming patient processing schedules, staffing issues and general operations. Other duties include reviewing log books and batch records prior to and after completion for accuracy and content and investigating Deviation Reports, including issuing follow up actions and closure. I am also the company liaison to our clients to which I am responsible for. Celgene Cellular Therapeutics, Cedar Knolls, NJ. 5/2002 - 10/2002, Research Associate 11/2002 - 8/03, Laboratory Manager Research Associate for the Department of Research and Development. Major projects included isolation and culturing of placental stem cells, genetic profiles of non-differentiated and differentiated placental stem cells by way of RT-PCR, neurogenesis and chondrogenesis of placental stem cells by chemical induction and HLA halo typing. Techniques employed are stem cell isolation from placental perfusate, tissue culture, DNA and RNA isolation from whole blood and purified cultured stem cells, PCR primer design, RT-PCR, agarose gel electrophoresis, and HLA halo typing via PCR. Laboratory Supervisor for the Placental Processing Team. Responsibilities include performing these skills as well as the training of personnel on specified techniques, safety and maintenance. Specialized techniques include cannulating the vein and arteries of the umbilical cord, placental stem cell isolation via perfusion through placental vessels, the preparation of transplantable stem cells by way of red blood cell reduction techniques such as hetastarch separation and Ficol Paque , cell viability via flow cytometry, use of a Cel Dyn for blood cell counts, and stem cell cryo preservation. Managerial duties also included creating and maintaining processing documentation, SOP development, inventory control, scheduling, data tracking and compilation and generating daily and weekly production reports. Thomas Jefferson University, Philadelphia, PA. 8/2001- 4/2002 Research Assistant Assistant research molecular biologist for the Department of Pathology. Major responsibilities were to devise recombinant SV40 constructs that were to be used as a vaccination modality to express HIV proteins other than envelope proteins for immunization purposes. Techniques employed were cloning, competent cell preparation, immunostaining, cell based ELISA, mammalian tissue culture, transfection and transdution of viral constructs into mammalian cell lines, virus production, purification and titering of viral constructs, western and northern blotting and PCR. Also certified to work in bio-safety level-3 and with radio-isotopes. United States Department of Agriculture, Wyndmoor, PA. 1/2001-8/2001 Biological Laboratory Technician Microbiological laboratory technician for the Microbial Food Safety unit. Tasks include media preparation, set up and active participation in probing for surface Listeria contamination on hot dogs. As well as, culturing swine fecal material to probe for Shiga-toxin producing E.Coli by way of colony hybridizations and immunoblots. Techniques employed are DNA isolation, PCR, Taqman PCR, bacterial plating, liquid bacterial cultures, serial dilutions, immunoblots and DNA hybridizations from bacterial colonies. Also responsible for maintenance, calibration and cleaning of equipment, notebook maintenance, maintaining organized spreadsheets of collected data, updating protocols and maintain inventory of needed supplies. DuPont, Newark, DE. 7/2000-11/2000 Assistant Molecular Biologist Molecular biology assistant scientist for the crop protection unit. Tasks included plant gene transformation, bacterial gene transformation, vector construction, plant maintenance, RT-PCR, PCR, DNA and RNA isolation, agarose gel electrophoresis, notebook maintenance. Lehigh University, Bethlehem, PA. 1/2000-5/2000 Laboratory Technician/Manager Responsible for the junior level molecular genetics laboratory. Responsibilities included the preparation of media and solutions, isolation of plasmid DNA , genomic plant DNA , and bacteriophage for laboratory stocks as well as the maintenance of bacterial and plant cultures . Managerial responsibilities encompassed the entire molecular biology department: duties included maintenance of core facilities equipment, making service calls, and ordering all supplies for the molecular genetics laboratory and core facility rooms. Also, responsible for the supervision and training of work study students.