Saul Pyle Email & Phone Number

Sydney, Australia

- Formulate and develop new products in alignment with product briefs and benchmarks.- Undertake ingredient research, facilitate the development of new product briefs.- Liase with ingredient suppliers, source raw material and packaging suppliers and pricing.- Review existing product ranges, provide critical assessment and identify opportunities for improvement and new variants.- Resolve technical formula issues, including instability, skin irritancy and packaging incompatibility.- Facilitate the identification and selection process of contract manufacturers for client products.- Prepare manufacture briefs for new products to be quoted by contract manufacturers- Undertake quality management system and GMP audits of contract manufacturers.- Perform critical review of formulation, development and laboratory management software including Coptis, Creativity & Formulator for the review of senior management.- Draft report for Research and Development Tax Incentive, including review of previous submissions, summarise new activities and new projects undertaken in the last financial year.- Creation of ‘Manufacturing Process Flow Diagram’ for both therapeutic and personal care products to replace traditional and difficult to follow stepwise manufacturing work instructions.- Develop and implement a series of modular guidance documents outlining the products, equipment, systems and processes in support of changes to manufacturing process flow diagrams.- Facilitate the transition of a range of personal care products for an Australian owned brand from New Zealand based manufacturing to Australia, including both personal care and therapeutic products.- Facilitate the development of NPD Systems and Processes using integrated Smartsheets and Google Sheets/Documents.

Kingsgrove

- Cost optimised a product range for a multinational customer.- Worked on the development of a nutraceutical skin range for a major Australian owned international brand - Created an Excel based Pharmaceutical Formulations Development program to more accurately draft formulations including active and excipient input quantities, overages, equivalences, calculating cost with ability to generate R&D bulk order and facilitate finished product specifications.- Oversaw pharmaceutical and personal care component of the ~$20M new product pipeline, including the development and implementation process from brief through to first production.- Oversaw the research and development of high quality and cost-effective registered and listed medicines, medical devices and personal care products across broad dosage forms including; tablets, hard gel capsules, powders, liquids, creams and gels- Drove the implementation of personal care and pharmaceutical new products into the business, initiating and preparing change controls, supplier qualifications, finished product specifications and manufacturing work orders.- Oversaw generation of marketing presentations, outline the market scope/regulatory framework, review market data (Aztec/Mintel), identify market categories, leading brands in sales and growth, their ranging, strategies, claims and ingredients in addition to gap analysis and identifying opportunities.- Review market trends using on-line tools including Prospector, Specialchem, Mintel GNPD, Trend Hunter, Cosmetics Business.- Monitor and report business KPI’s and trends, including monthly Wins, Retention, Fail to Gains and Losses as related to new products

Sydney, Australia

- Contribute to a 25% reduction in customer complaints over a 9 month period with a decline in the associated business risk.- Contribute to the ~35% reduction in deviations over the same time period with an associated QA labour cost saving.- Apply the principles of GMP to unique to industry, intermediate-in-batch semi-continuous manufacturing process (IBSCMP) for the production of gummies/pastilles.- Integration of collaborative work management and automation into quality management systems, including CAPA’s and audits, improving the time to close-out.- Manage and lead the Quality Assurance and Quality Control departments comprising twenty-two staff across two facilities.- Develop and maintain a PIC/S compliant GMP Quality System for the purpose of manufacturing complimentary and listed OTC medicines.- Manage certifications, accreditations and licensing, as associated with external audits including Therapeutics Goods Administration, HACCP, NSW Food Authority and MSC across two facilities.- Chair periodic quality related meetings on an as needs basis in addition to quarterly quality review meetings and preparation of annual quality reports.- Review process deviation and corrective and preventative action and contained root cause analysis, corrective actions and risk assessment.- Perform continuous trending and review of product quality and implement targeted strategies to reduce quality issues.- Develop and contribute to the implementation of training modules and new procedures aimed at resolving observed quality issues.- Ultimately responsible for ensuring that Good Manufacturing Practices are adhered to, throughout the company’s operations

Sydney, Australia

- Managing the new product pipeline, overseeing the coordination of the development team in addition to the sales, accounts, quality and production teams.- Facilitate the ongoing alternate material sourcing requirements, assess product impact and risk.- Develop and implement department SOP’s, guidance documents and tools to achieve greater control of the NPD process for improved quality and speed of output.- Create and employ Quality by Design (QbD) principles into the R&D process utilizing predictive techniques and ‘beyond specification’ product testing with the aim to minimize or prevent issues during scale-up.- Monitor and report department KPI’s, including new product briefs, pipe-line valuations, costing approval rate, submission approval rate, cumulative approval rate, alternate raw material sourcing benefits and reprocessing/rework value.- Identify opportunities for new product innovations capable of providing Sphere competitive advantages and integrate into Proprietary Ingredient.- Perform root cause analysis on failed batches, execute batch recovery and implement preventative actions to prevent or minimize recurrence.- Development and implementation of core training modules for the purposes of educating nonskilled or inexperienced staff in granulation, compression and coating processes.- Liaise with current and prospective customers; improve relationships and customer confidence in the organisations technical capabilities.- Facilitate the identification and investigation of process and equipment related improvements impacting quality or cost with consideration for financial measures including; return on investment value (NPV) and internal rates of return (IRR).

Melbourne, Australia

- Drive the development of in-house in-vitro sunscreen testing facilities and procedure development, maximize the relevance of acquired information, interpret and disseminate data.- Monitor market trends and evolutions; identify new opportunities and technologies with potential for capitalization and integration into new projects and innovative products.- Contribute project summaries and supporting data for the preparation of annual R&D tax concession submissions.- Monitor and report department KPI’s with relation to target project time, target costs, customer approval rates, cost saving opportunities and expenses.- Oversee the implementation of new products into the manufacturing environment, with consideration for potential quality and process related issues.- Direct and delegate duties for product development chemists and drive the on-going development of staff and the department as a whole.- Manage R&D projects, research studies, budgets, product reviews and evaluate product submission documents and scale-up related tasks.- Liaise with internal and external stakeholders where expertise may be provided, including formulation design, manufacturing process, quality, safety, documentation, regulatory, registration, artwork and packaging.- Undertake statistical stability analysis, utilizing outlier detection and confidence intervals to substantiate shelf life, collate product safety, quality and performance data and generate product quality reports and product dossiers.

Sydney Area, Australia

- Enhancing quality through continuous business improvements.- Achieving customer requirements and fulfill GMP agreements, including scheduled audits.- Overseeing all quality related aspects of supply chain from entering of BOM's, purchasing, receipt of raw materials and packaging, through to release for sale of final product.- Direct and delegate duties for technical personnel including the QA and Product Development within Jalco Cosmetics.- Responsible for overseeing day to day quality control of raw materials, packaging, bulk and finished goods, including the maintenance of standards, references and documentation.- Plan and effectively use resources, measure performance and report to management on quality goals and KPI’s.- Responsible to oversee support and achieve the company’s and department quality goal to ensure products conform to the quality & regulatory requirements and only approved products are dispatched from the warehouse.- Responsible to oversee the site GMP Management and to comply with ‘Code of Goods Manufacturing Practice for Therapeutic Goods’. Responsible person for Quality Release of Therapeutic Goods.- Oversee the provision of training for technical employees within Jalco Cosmetics and for providing training for all staff on quality procedures and requirements.

Sydney Area, Australia

- Formulate and develop new products according to customer briefs including; sunscreens, hand/body washes, shampoo, conditioners, hairstyling products and moisturizers- Undertaken stability testing on new products and compile stability reports.- Resolve manufacturing process quality and efficiency- Identify cost saving opportunities.- Attend to any internal or customer technical queries including; material changes, MSDS’s, ingredient listings, customer complaints and other issues.

- Responsible for the function and supervision of twenty compounders and dispensers across three shifts.- Train compounding staff in batch making processes and associated procedures.- Maximising department output whilst ensuring quality product according to ISO9001 standards.- Schedule work according to production plans and capabilities of manufacturing department and resources.

- Formulation of new products (skin and hair products, liquid soaps & household products).- Prepare finished product samples for customer evaluation. - Conduct physical, instrumental and chemical analysis on all laboratory batches.- Investigate batch making issues, identify potential contributing causes and implement systems to prevent recurrence where appropriate.- Rectification of failed batches.- Supervise batch making of new products or changes to existing products, accurately reporting all activities.- Stability testing of various consumer and household products.- Preparation of MSDS’s for new products.- Liaise with customers and suppliers regarding environmental and safety concerns.

Pgrd Diploma - Safety Science, Toxicology, Dangerous Goods, Hazardous Substance And Oh&S

Bachelor Of Science, Chemistry

Diploma Of Personal Care Formulation, Cosmetics And Personal Care, Distinction