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Mayne Pharma Group Limited (Mayne Pharma) is an ASX-listed specialty pharmaceutical company focused on applying its drug delivery expertise to commercialize branded and generic pharmaceuticals. Mayne Pharma also provides contract development and manufacturing services to more than 100 clients worldwide.

Medochemie Ltd. develops, licenses, manufactures, markets and distributes branded generic and super-generic pharmaceutical products as well as our own patented brands from our base in Europe, to the Middle East & Africa, through to the Far East. Outside our 19 core offices, we developed a network of trusted agents and partners allowing us to operate in more than 100 countries.Medochemie Ltd has eleven manufacturing plants and facilities. Nine are in Cyprus, one in the Netherlands, and one in Vietnam. We have acquired and maintain 3,800 marketing authorisation licenses for 630 different pharmaceutical products, classified in over 10 therapeutic categories. We operate in accordance with the strictest quality standards and in full compliance with European guidelines.Medochemie is a founding member of the European Generic Medicines Association (EGA).Directly responsible for Production, Quality Control, Quality Assurance, Procurement and Logistics, Systems and Planning, Technical Services and Information Technology

In Jan-09, in addition to responsibility for the sterile plant, assumed responsibility for management of operations of GMP-certified (United States Food and Drug Administration, European Medicines Agency) secondary non-sterile operations. Reporting to Managing Director, in addition to responsibility for the delivery of sterile injectable Redipen bulk dual chamber cartridges and Remicade vials (both lyophilised powder for injection), assumed responsibility for Zetia tablets, Nasonex aqueous nasal spray, Asmanex dry powder inhaler and the development of new capsule and tablet products.Member of site leadership team (Heads of Department)Director of Company's secondary operations (sterile fill and finish facility and non-sterile operations) Responsible for Production, Maintenance, Technical Training, Planning, Buying, Continuous Improvement functions within the IPTCombined facility operating budget ca. USD 28m (excluding materials and new product introduction costs)Combined 124 employees based in secondary operationsTechnologies: high speed bottle filling (tablets, aqueous nasal spray); high speed dry powder inhaler device filling; fluid bed granulation/drying; high shear granulation; roller compaction; high speed compression; high speed encapsulation; aqueous film coating; aqueous nasal spray manufacture; dry powder inhaler manufacture (micronisation and agglomeration)Capital employed: ca. USD 230 millionApproximate commercial value of product streams: ca USD 8.2 billion p.a.

Responsible for management of operations of GMP-certified (United States Food and Drug Administration, European Medicines Agency) pharmaceutical sterile products manufacturing site. Reporting to Managing Director, responsible for the delivery of sterile injectable Redipen bulk dual chamber cartridges and Remicade vials (both lyophilised powder for injection)Member of Schering Plough Limited site leadership team (Heads of Department)Director of Company's sterile fill and finish facilityFacility budget ca. USD 18m (excluding materials)62 employees based in Biotech operationsSole site of manufacture for Redipen (interferon -2b) (ca. USD 900M p.a. sales)Manufacture of Remicade (infliximab) lyophilized vial product (ca. USD 2,000M p.a. sales)Work with Materials Management, Quality, Engineering and Maintenance, Technical Services and other support functions to provide direction to the Biotech business unitParticipate in Site Quality Council, Validation Review Board and Training CouncilTechnologies: dual chamber (wet and dry) cartridge compounding, sterile filling, inspection and labeling; lyophilisation; vial compounding, sterile filling, inspection and labelingCapital employed: ca. USD 120 millionApproximate commercial value of product streams: ca USD 2.9 billion p.a.

Responsible for management of GMP-certified (New Zealand Ministry of Health) pharmaceutical new product development site, including strategy, operations, site facilities, finance, human resources, regulatory, statutory and technical. Reporting to Auckland, New Zealand Director and Board, responsible for the delivery of new product development and commercial objectives from the Fiji siteMember of Douglas Pharmaceuticals Limited Management Committee (corporate structure for developing strategy for the Group)Resident Director of the Fiji companySite budget ca. NZD 2,000,000 (excluding materials)33 employees based in FijiGrew site's product development portfolio four-foldIntroduced commercial operations to utilise excess capacity, providing ca. NZD 3m p.a. of contract salesGrew and developed site capabilities to an international standard, whereby the Group now recognises Fiji as the dedicated site of high-potency containment drug product development (antineoplastics, immunosuppressants, androgen antagonists)Increased activity on the site four-fold with only an additional 50% staffMaintained Medsafe GMP certification and preparing site for E.U. certification (2007) and US FDA pre-approval inspection targeted 2008Managed the delivery of technical requirements for several major generic drug productsIntroduced key cultural interventions to enhance productivityIntroduced knowledge-based management approaches such as site balanced scorecard, KPIs, employee personal performance planning.Liaise with government (Fiji Islands Trade and Investment Bureau, Prime Minister, Ministries of Justice, Commerce, Trade) to effect legislative changes to the Company's benefit (Patent Law and Pharmacy and Poisons Act)

Responsible for management of the Singapore site's Operational Excellence program, a corporate initiative to enhance manufacturing excellence in the Global Manufacturing and Supply networkDeployment of LeanSigma initiative (Lean Manufacturing and Six Sigma) across this 400 employee siteManaged ongoing business baselining and analysis along the dimensions of customer and market, physical value, knowledge value, organisation design, management systems and financial Deployed Network Excellence Certification initiative Managed the performance and activities of seven graduate LeanSigma ExpertsResponsible for site's business continuity planningManaged successful Year 2000 computer compliance program (USD 300 million of assets on site)Developed site's productivity and growth business strategyDirect responsibility for several projects, including yield improvement, cycle time reduction, equipment performance, inventory reduction, manufacturing velocity, process stabilisation, statistical process control and optimization (DOE)Contributed to organisation restructure into value streamsDevelopment of site's participatory business improvement schemeDevelopment of specific initiatives for Value Velocity, including 'hidden factory', technology framework and values stream initiatives

Participated in commissioning and post-commissioning process activities for the Singapore steroids bulk active pharmaceutical ingredient facilityCommissioning USD 150 million U.S. Food and Drug Administration steroids bulk drug substance plantCommissioned several organic synthesis and physical processes (batch reaction, separation, distillation, filtration, centrifugation, drying, micronisation, barrier isolation technology)Commissioned USP Purified Water plantProvided process chemistry support for facility's steroids production processesDeveloped Standard Operating Procedures, batch documentation and validation documentation for facilityResponsible for process evaluation and monitoring, improvement and trouble shooting

Responsible for representing the company's membrane filtration technology to laboratory, industrial and educational markets in New South Wales, Queensland and the Australian Capital Territory.Grew sales of microfiltration products in the territory against well-established brands (Millipore, Pall)Key account management of hospitals, pharmaceutical companies, food and beverage and electronics marketsClient care for pharmacists, laboratory professionals, purchasing executivesGrew portfolio of process filtration, laboratory filtration, medical device and membrane sales in the territoryCompleted technical trials with clients to enhance product performance and increase sales through delivery of value propositions relevant to their businesses

Responsible for facility's parenteral solutions manufacturing unit, supervising five manufacturers on a three shift operation.Ensure quality and schedule adherence for the solution preparation unitCoordinate with Production Manager, Quality Assurance, Engineering and manufacturers to deliver parenteral solutions to the facility's numerous production linesTo maintain safety and GMP of the solution preparation unitPrepare, review and introduce Standard Operating ProceduresResponsible for training and development of manufacturersResponsible for dispensary activitiesResponsible for in-process control and batch release for fillingResponsible for Schedule 8 (Drugs of Addiction) dispensing and controlLiaise with Logistics to ensure availability of materials for schedule adherenceLiaise with Quality Assurance to resolve component failures or out-of-specification investigationsPrepare, review and introduce batch documentationIntroduce new developments in sterile filtration technology and responsible for all aspects of filtration supplies

Responsible for laboratory staff of ten and then the quality assurance activities of the CompanyManage laboratory and work flowRelease of input materials, work-in-progress and finished productTraining of staff in GMP, GLP, SOPs, analytical methods and safetyMaintenance of analytical instrumentation Manage stability testing program Release master formulations, manufacturing instructions and product specificationsLegally responsible for product quality by way of signatory on the License to manufacture Therapeutic GoodsAct on product complaintsLiaise with Therapeutic Goods Administration Maintain internal quality audit program

Development and validation of analytical methods and production processesInvestigate alternative production processes for pharmaceutical productProduction process parameter optimisationStability analysis

Develop analytical methods using classical and instrumental techniquesAnalysis of stock feed, food products, edible oils, oil by products and cosmetics in accordance with standard test methodsEstablished the Company's Environmental Chemistry and Pharmaceuticals Analysis unitsExtensive experience with AAS, HPLC, GLC, UV-VIS spectrophotometer and ion-selective electrochemistry

Chemical analysis of input materials and finished products for pharmaceutical productsUse of both classical and instrumental analytical techniques (HPLC, GLC, UV-VIS spectrophotometer, IR spectrophotometer, flame photometer, TLC

General chemical analysis of foods, food products, pharmaceuticals, cosmetics, water, trade wastes, veterinary products, input materials for pharmaceutical compounding, construction materials, lubricants, metals and metal alloys, minerals and ores, masonry extracts, petroleum products, solvents, waxes, fats and oils, emollients, detergents, paints, resins, pigments and agricultural chemicalsUse of both classical and instrumental analytical techniques (HPLC, GLC, TLC, IR, UV*VIS, ion selective electrochemistry