Vojko T.

RESUME Personal Details Vojko Tomasic Adress : Vojko Tomasic, Sokolovac 17, 10000 Zagreb; Croatia Phone : 003853722373; email: Qualifications and Education : Master of Engineering- Biotechnology Education : Faculty of Biotechnology; Zagreb Faculty of Chemical Enginnering; Zagreb-postgarduate study (one year) Career History : Work 15 years R&D of production process; laboratory development of new experience products and better process solutions. (production of pharmaceuticals and active pharmaceutical ingredients) Work 13 years as Productiin Technologist in production of active pharmaceutical ingredients (API) Application of good manufacturing practice principles (GMP) Validation of various processes for the production of API I have great experience in translating documents for Food and Drug Inspection (FDA) from Croatian to English language and vice versa Current Dates: Company Name Pliva Croatia Ltd Job role : Research and development Production Technologist Description of Achievements: Production of ascorbic acid- 1000 T/year (development process of crystallization of ascorbic acid; development process of drying of the wet ascorbic acid crystalls;development process of production of ascorbic acid from Na ascorbate water solution using ion exchange; development process of biomass coagulation and flocculation(fermentative solution of one intermediate in ascorbic acid production process ) (All procedures where developed on laboratory,scale up; equipment and instruments selected and purchased; developed procedures are tested on industrial scale. We have get the award for quality of a product from Abbott Laboratories. Production of Na-ascorbate (USP, BP) (own developed production procedure on laboratorium scale, scale up; equipment and instruments selection and purchasing;developed procedures are tested on industrial scale) Production of S-adenosyl,methionine (development of fermentation process,extraction, extract purification by filtration, product isolation using ion exchange,product concentration using membrane filtration) (own developed production procedure, scale up; equipment and instruments selection and purchasing; developed procedures are tested on industrial scale) Free flow oxytetracycline hydrochloride crystals (semitechnical- own developed production procedure; development procedure on laboratory scale; scalle up-Semitechnical; production of 100 kg/batch) Procedure development according customer rerquirements. Oxytertracycline calcium (own developed production procedure, scale up; equipment and instruments selection and purchasing; production according customer requirements. Acarbose(purification of water solution and crystalline acarbose isolation)- own developed procedure. Sorbitol (70% w/w solution and crystallinre sorbitol) procedure development (own developed procedure) Mupirocin (production procedure; development of fermentation; biomass separation, purification of water solution of mupirocin, crystallization, isolation and drying; development tested on industrial scale) Monoacetoneglucose(MAG) (own developed production procedure on laboratorty, scale up; instruments selection and purchasing; application in production process) Product is produced according customer requirements Diacetoneglucose (DAG) (own developed production procedure on laboratory scale, scale up; Semitechnical production procedure) Energy saving (reduction of water consumption in fermentation and isolation of mupirocin by using cooling towers and water chilers in cloosed loop) Sulfate and chloride waste water treatment (own developed procedure; neutralization and sulfate isolation as Na sulfate; crystallization, isolation and drying of crystalls; application in production). Optimization of various procedures (filtration, crystallization, evaporation, distillation, ion exchange) in production of ascorbic acid, oxytetrcycline and mupirocin All above mentioned production procedures excluding S-adenosylmethionine, Monoacetoneglucose, Diaccetoneglucose and waste water treatment where made according the requirements of GMP. +Description of responsibilities : Responsible for production process analysis, laboratory experiments for research and development suggestion, reporting of results, application of results on industrial scale. Responsible for scale up of processes , projects suggesstions , managing of the whole or part of the project,application, reporting of results. Responsible to contact equipment producers, raw material producers. Responsible for tzhe purchased equipment qualiofication design,instalation and operation. Responsible for processes (procedures) validation and GMP regulative in production of API application. Responsible for raw material testing and reporting the results Six Sigma process exellence principle application. Description of the role : Ascorbic acid production process research and dvelopment-team member Sodium ascorbate production process research, development and application - team managing S-adenosylmethionine production proces research, development and application -team member Free flow oxytetracycline hydrochloride crystals-team managing Oxytertracycline calcium-team managing Mupirocin-team member Monoacetoneglucose-team member Diacetoneglucose-team member Waste water treeatment (isolation Na sulfate) -team managing Energy saving (reducing water consumption in production of mupirocin)-team member (Six Sigma) Certificates : -FDA 21 Code of Federal regulations Part 210,211 (2007) -The rules governing Medicinal Products in EU; GMP vol.4, Medicinal products for human and vetrerinary use EudraLex 2005, Part Iand II with relevant annexes (2007) -:FDA ICHQ7A (GMP Guidance for API) (2007) - EU GMP Part II (Basic requirements for API and starting materials) (2007) -ICHQ7(GMP Guidance for API) (2007) -Cleaning validation (2007);Process analytical technology (PAT) (2007) -Rouging, Passivation (2007);Total organic carbon method(TOC)-2007 -Clean room (2007);Cleaning in Pharmaceutical industry (2007) -Domnick Hunter (Filtration process validation;OillX -evolution (new generation of compressed air filters, compressed air preparation,sterile filtration of compressed air and gasses,filtration of liquids (2006) - Water preparation for laboratory use (Milipore 2005) -Generic pharma business (Pliva 2006) -Authorized for dealing with toxical substances (Croatian Institute of Toxicology -2007) Personal Interests : To be with familly and friends in free time; gardening (flowers), sport watching on TV,walking,swiming, dancing, cycling, table tenis, voleyball,reading good book, going to theatre, concerts (classic, gospel, country) visit museum,going to the church on Sunday . My inteterests are also organic food, alternative energy sources, clean water, soil and air.