Technical Consultancy Services Pty Ltd

 

Technical Consultancy Services Pty.Ltd. Address: 20 King St., Rockdale NSW 2216 ph. 61 2 9597 7115 fax 61 2 9556 3361 ABN: 88 057 988 520 Contacts: Scientific Director : Dr. James Rowe Ph.D. CChem. MRACI, Scientific Director. C.V. jim@techconsult.com.au Commercial Director : Mr John A Staton M.A.I.P.(Dip). M.A.I. Ex. (Dip) C.V. john@techconsult.com.au Analytical Services: Craig Dennyson B.Sc. C.V. craig@techconsult.com.au Formulation Development Manager : Mr George Orban B.Sc. UNSW C.V. george@techconsult.com.au       Back to Top CURRICULUM VITAE Dr. James S. Rowe B.Pharm., M.Sc., Ph.D., M.P.S.,M.R.A.C.I., C Chem. EDUCATION: 1980 Graduated Doctor of Philosophy - The School of Pharmacy, University of London 1976 Graduated Master of Science - Chelsea College, University of London 1966 Graduated Bachelor of Pharmacy - University of Sydney 1962: Completed NSW Leaving Certificate - St. Joseph's College, Hunters Hill, Sydney MEMBERSHIPS: Pharmaceutical Society of Australia Royal Pharmaceutical Society of Great Britain Royal Australian Chemical Institute Australian Society of Cosmetic Chemists   EMPLOYMENT HISTORY: February 1967 - February 1969 PRODUCT DEVELOPMENT CHEMIST in the Research Division of Riker Laboratories Pty.Ltd., Sydney, Australia. Duties included the design and subsequent evaluation of a range of pharmaceutical dosage forms including tablets, capsules, liquids, creams and aerosols. Extensive work on stability testing was also undertaken. There was also an involvement in the preparation of clinical trial material and liaison with the marketing function on new product introduction. I was also involved in a manufacturing support role by undertaking "troubleshooting" activities in the manufacturing area. March 1969 - July 1971 QUALITY ASSURANCE ASSOCIATE at Eli Lilly & Co., Sydney, Australia. My duties consisted of the setting up and maintenance of all Quality Control procedures from receipt of raw materials to assay of final product. This included in process manufacturing controls, raw material and packaging standards as well as compliance with analytical specifications on the finished product. July 1971 - December 1972 I relocated to the UK during this period and was involved in various hospital and community pharmacy work. This included approximately six months in the dispensary of St. John's hospital for the diseases of the skin in London and nine months in St. Mary's Hospital, West London. December 1972 - December 1976 During this time I was employed by ER Squibb and Sons Ltd., Twickenham, Middlesex U.K in various positions including the following: PRODUCT PLANNING MANAGER, responsible for the marketing and profit contribution of the company's range of antibiotic and antifungal products. I was subsequently promoted to MARKETING PLANNING MANAGER and was responsible for the co-ordination of R&D, Marketing and Regulatory departments on the introduction of new products to the UK market. During my employment at ER Squibb & Sons Ltd. I successfully completed an M.Sc. degree at Chelsea College, University of London in Biopharmaceutics. December 1976 - April 1983: Having completed the M.Sc. degree, I accepted a position as a RESEARCH FELLOW at the School of Pharmacy, University of London working under the supervision of Prof. J.E. Carless. In February 1980 I was appointed to a LECTURESHIP in Pharmaceutics which involved lecturing and practical supervision of both undergraduate and postgraduate students in the following areas: Biopharmaceutics and Pharmacokinetics Pharmaceutical formulation Analysis of drugs and metabolites in body fluids Dispensing I was also involved in the setting up of the M.Sc. course in Clinical Pharmacy at the School of Pharmacy and Northwick Park Hospital and was responsible for giving a series of lectures in Clinical Pharmacy for the course as well as supervising research projects. During my employment at The School of Pharmacy, I completed a Ph.D. degree in Pharmaceutics. My thesis centred around the formulation and subsequent testing of more effective forms of non-steroidal anti-inflammatory agents, with particular emphasis on microencapsulated and sustained release formulations. My thesis was entitled "The bioavailability of microencapsulated indomethacin" which resulted in a product which has been granted international patent rights. April 1983 - September 1986 I left academia to setup a consultancy business (HR Health Care Ltd) specialising pharmaceutical formulation, novel dosage form design, stability testing and marketing for various clients in the UK and Europe. I was a joint DIRECTOR of this company. During this time I was also a partner in a community pharmacy in Hereford, U.K. September 1986 - August 1990 I returned to Australia in September 1986 and was appointed TECHNICAL MANAGER at Abbott Laboratories, Sydney in September 1986. In this position I was responsible for new product and process development for affiliated companies in the Pacific, Asian and African areas of the world. In this position I was manager of the Area Technical Centre and the position involved the supervision of the work of eight scientists involved in the design, evaluation and testing of new formulations and processes in the pharmaceutical industry. The work also involved conducting "in house" bioavailability studies on new and reformulated products. A considerable time was spent visiting affiliated companies in The Phillipines, India, Pakistan, South Africa and New Zealand solving technical problems associated with process and product development. August 1990 - Present My present position is SCIENTIFIC DIRECTOR of Technical Consultancy Services Pty.Ltd. This company was jointly founded by myself and a colleague in 1990 to provide consultancy services to the pharmaceutical and allied industries. Areas of consultancy work include new product concepts, formulation and dosage form design, stability testing, regulatory affairs and marketing. All aspects of product development required to carry products from initial concept to marketing are covered. Facilities include a well equipped laboratory with HPLC, GC, UV, GC-MS, AA and pilot manufacturing and testing equipment for most pharmaceutical dosage forms. I have been a past member of the Pharmacy Graduate Training Committee of the NSW branch of the Pharmaceutical Society and also a TUTOR for graduate students. I am also currently a DIRECTOR of Dermatest Pty. Ltd. which is engaged in providing an extensive range of dermatological tests for the pharmaceutical and cosmetic industries. Tests include a full SPF testing facility, Repeat Insult Patch Tests and Cumulative Irritancy Tests. PUBLICATIONS "Comparisons of the in vitro dissolution behaviour of various indomethacin formulations with their in vivo bioavailability. " J Pharm Pharmacol 1981; 33: 561-564 "The use of the critical flicker fusion frequency for evaluating some central nervous effects of two indomethacin formulations." J Pharm Pharmacol 1981; 33 :336-337 "The influence of the microcapsule wall on the assay of indomethacin microcapsules in the presence of antacids -implications for product stability." Int j Pharm 1982; 13:313-320   "Investigations on the in vitro dose related metabolism of indomethacin in four laboratory species." European Journal of Drug Metabolism & Pharmacokinetics 1982; 7: 159-163   Formulating for Effect. in "Tea Tree Oil - The Genus Melaleuca" Ed. Southwell I. & Lowe R. 1999: 207 - 212. Harwood Academic Publishers.   Melaleuca Oil - a natural healthy alternative. Cosmetics, Aerosols & Toiletries in Australia 1999; 11: (5) 12-15. PATENTS I am the joint inventor of thee international patents relating to the potentiation of the antibacterial action of melaleuca oil in the treatment of acne, A novel preservative formulation and a novel dosage form for oral non-steroidal anti-inflammatory agents.   Back to Top CURRICULUM VITAE   John Alexander Staton M.A.I.P.(Dip). M.A.I. Ex. (Dip)   EDUCATION:   1963 Completed NSW Leaving Certificate Sydney Boys High School, Sydney   1969 Graduated Biology Certificate Sydney Technical College   1973 Graduated Packaging Diploma Sydney Technical College   1985 Graduated Diploma in Export Management Australian Institute of Export   MEMBERSHIPS   Australian Society of Cosmetic Chemists - Life Member and Past President Australian Institute of Packaging (Diplomate Member) Australian Institute of Export (Diplomate Member)   Past Chairman and Member Technical Committee - Proprietary Association of Australia Past Member NH&MRC GMP Sub-committee. Member TGC TGO Sub-committee on Child Resistant Packaging. Chairman - Standards Association Committee on Child Resistant Packaging. Member - Standards Australia Sunscreen Testing Committee Member - ASMI Sub-Committee - Sunscreens Member - ACCORD Sub-committee - Sunscreens Australain Standards Delelgate to ISO Sunscreen Workimg Group   EMPLOYMENT   August 1990 - Present I am presently COMMERCIAL DIRECTOR of Technical Consultancy Services Pty.Ltd. (T.C.S.) and Director of Dermatest Pty Ltd (Dermatest) . T.C.S. was jointly founded by myself and a colleague in 1990 to provide consultancy services to the pharmaceutical and allied industries. Areas of consultancy work include new product concepts, formulation and dosage form design, stability testing, regulatory affairs and marketing. All aspects of product development required to carry products from initial concept to marketing are covered. Facilities include a well equipped laboratory with HPLC, GC, UV, GC-MS, AA and pilot manufacturing and testing equipment for most pharmaceutical dosage forms.   I am also currently a DIRECTOR and 50% owner of Dermatest Pty. Ltd. which is engaged in providing an extensive range of dermatological tests for the pharmaceutical and cosmetic industries. Tests include a full SPF testing facility, Repeat Insult Patch Tests and Cumulative Irritancy Tests.   PREVIOUS EMPLOYMENT 1989 - 1993 SciPharm Pty Ltd - Consultant Chemist Developed GMP Training software and conducted GMP training in Pharmaceutical plants throughout Australia. Prepared Standard Operating Procedure (SOP) documentation and GMP control documentation. Conducted audits and assisted with therapeutic facility design 1986 - 1989 General Manager - Soul Pattinson Laboratories Pty Ltd Reporting to CEO and responsible for all aspects of therapeutic manufacturing facility. 1977 - 1986 Operations Manager - British Medical Laboratories Pty Ltd Reporting to CEO and responsible for operation of manufacturing plant. Included product development and production. 1969 - 1977 Development Manager - Soul Pattinson Laboratories Pty Ltd Product development of over 200 formulations, packaging development and design. Development of product range for the AMCAL pharmacy franchise group. Technical support and development of products for export to S.E. Asia and Middle East. Technical support for manufacturing operations in Malaysia and Hong Kong. 1966 - 1969 Senior Chemist - Soul Pattinson Laboratories Pty Ltd Management of Quality Control and Assurance functions. Development of analytical techniques and methodology using U.V. and I.R. Spectroscopy and Gas Liquid Chromatography. 1966 Field Assistant - Merck Sharpe & Dohme Evaluation of veterinary formulations in animal trials. 1994 - 1996 Laboratory Assistant - Dept of Pharmacy Sydney University Preparation of pharmaceutics and organic chemistry laboratories for student practical sessions. Assistance of development of newly established laboratories for practical pharmacognosy and dispensing.   PUBLICATIONS and PATENTS Patent : US Patent 5,801,214 - Dental Retaining Composition - 1998 WO 2005081673 - Topical Polymeric Antimicrobial Emulsion AU 20032181745 - Insect Repellant WO 2004010783 - Insect Repellant EP 0983092 - Preservative Composition Containing Tea Tree Oil AU710919B - Acne Treatment   Software: The INhouse Trainer : GMP Training Software for Therapeutic and Food Industry.   Papers : "Melaleuca Oil - a Healthy Natural alternative." Cosmetics, Aerosols & Toiletries in Australia 1999; 11: (5) 12-15. Winner Best Presentation and Best Scientific Content Australian Society of Cosmetic Chemists Conference 1998   "Australian Tea Tree Oil - A Versatile Natural Material for Cosmeceuticals" ASCS 3rd Scientific Conference Taipei, Taiwan 1997   "Instrumental (In-vitro) UVA Measurement and Validation" WSMI Word Self-Medication 4th Asia Pacific Regional Conference 2000   "Determining the Contribution of Individual Active to SPF - a Proposed Methodology " Poster at IFSCC Congress, Orlando Florida, USA 2004   "Insecticides don't kill lice but Formulations of Insecticides do!". Symposium on the "Biology and Control of Lice" at the XXII International Congress of Entomology, Brisbane 15-21 August 2004.   "Country by Country Comparison of Key Parameters in National SPF Testing Protocols"  International Symposium on Photoprotection Test Methodologies Sydney 2006   Back to Top CURRICULUM VITAE   Formulations Development Manager : Mr George Orban B.Sc. UNSW   EDUCATIONAL QUALIFICATIONS   1978 Higher School Certificate (De La Salle College, Ashfield)   1983 Bachelor of Science (Industrial Chemistry - UNSW)   WORK EXPERIENCE 1999 (March 8) &endash; Present: TECHNICAL CONSULTANCY SERVICES Technical Consultancy Services (TCS) is a consulting laboratory assisting many large and small companies in Research and Development, stability studies and analytical method development, specialising in pharmaceutical, veterinary and therapeutic products. Through its associated company Dermatest, sunscreens are developed and tested for their Sun Protection Factor (SPF). TCS does not market its own products nor does it have a production facility.   Formulation Development Manager: Responsibilities include formulation of new products, preparation and monitoring of stability batches, liaison with clients and suppliers, organisation of external testing as required (e.g. microbiological testing and efficacy studies) and maintenance of documentation. 1995 (November 20) - 1998 (November 13) : C.P. TECHNOLOGIES PTY. LTD. C.P. Technologies was a contract filler of aerosol and liquid products. Two of its major customers were Sabre Corporation ("Fudge" brand of products) and Pearson's Products. CPT was also a supplier of hair care products to a number of different salons. It won an industry award in 1997 for its use of "Pecap" technology. The company appointed an Administrator to handle its financial affairs in July 1998 and went into liquidation in November 1998. Technical Manager Responsibilities included Research and Development, generation of all documentation relevant to batch manufacture and production runs, troubleshooting of batch and production problems, providing assistance to customers on regulatory affairs (e.g. Poisons Schedules, Dangerous Goods Codes), regular liaison with customers and suppliers on Technical and Quality issues as well as various "routine" Quality Control functions. Major achievements include the formal establishment of the technical function at C.P. Technologies and successful launches of products in compressed gas and "Bag-In-Can" systems.   1994 (April 18) - 1995 (November 10): AEROPACK AUSTRALIA PTY. LTD. Aeropack Australia is also a contract filler of aerosol and liquid products. Some of its major customers included, at the time, Helene Curtis, Lever-Rexona, Australian Grocery Holdings (Coles Supermarkets) and Bristol Myers. Technical Manager: Responsible for all technical functions including Quality Control of batch concentrates and finished products, troubleshooting of batch and production problems, some Research and Development work and liaison with customers and suppliers on various technical and quality issues.   Major achievements include the improvement of documentation procedures and the introduction of raw material lot numbering. 1989 (July 3) -1994 (March 31): RECKITT & COLMAN PRODUCTS PTY.LTD. (Formerly Samuel Taylor) Employed by Reckitt & Colman in various capacities between 1989 and 1994. 1989-90 Product Development Chemist Responsible for Laundry Care products, particularly Ironing Aids and Presoakers. 1991-92 Quality Control Supervisor - Aerosol Laboratory Responsibilities included processing of consumer complaints, troubleshooting of batch and production problems, liaison with suppliers on quality issues and monthly reporting of laboratory activities to senior management. 1992-93 Mixing Area Supervisor - Aerosol Factory Responsibilities included arranging work for compounders according to production schedules and ordering of bulk solvents and propellants. 1993-94 Product Development Scientist Responsible for Disinfectants, Hard Surface Cleaners, lavatory care and issues relating to Formaldehyde replacement in formulations. The disinfectant work required familiarity with the Therapeutic Goods Act. Courses undertaken at Reckitt & Colman include: - The New Supervisor, - Train the Trainer, - Effective Business Presentations, - Interviewing and Selection Skills.   Major achievements include the successful launch of a number of products including reformulated aerosol and liquid "Fabulon" and the revamped "Pine-O-Cleen" range. 1984 (August 27) -1989 (June 16) : S.C.JOHNSON & SON PTY LTD Product Development Chemist: Responsible for development and maintenance of various household products including air fresheners, laundry care, lavatory care and insecticides. This also included responsibility for registration of insecticide products with various Government departments. Major achievements include the launch of the "Protector" (now "Raid") dry spray insecticides and the successful preparation of registration packages for various new and existing insecticide products.   PROFESSIONAL ASSOCIATIONS - Member of the Australian Society of Cosmetic Chemists since 1995. -With the exception of Technical Consultancy Services, the abovementioned companies have all been members of the Aerosol Association of Australia. Languages spoken (other than English) include fluent Hungarian and some knowledge of German. Back to Top   Craig Dennyson B. Sc. University of Stellenbosch Stellenbosch, South Africa Bachelor of Science (Food Science, Biochemistry) 1999   - More than five years varied laboratory experience, both technical and analytical in a range of industries, with extensive hands-on production experience. - Thoroughly proficient in HPLC, GC, GC/MS, AAS and a wide range of modern instrumentation operation, calibration and resolving of technical problems. - Excellent analytical and documentation skills, with a proven record of working accurately under pressure, within strict laboratory policies.   - South African Bureau of Standards ISO 9002(Quality systems &endash; Model for quality assurance in production, installation and servicing) - South African Bureau of Standards HACCP - The implementation and management of a hazard analysis and critical control point)