Benjamin Sauer Email & Phone Number

Cambridge, Cambridgeshire, Gb

Part of AZ Lean CoE, leading the Asia Pacific Lean Academy with the delivery of experiential and transformative coaching designed to ensure lean leadership is brought to life in the workplace through a blended mix of theory, simulation, go-look-see, coaching, and reflection. Reporting to the Global Academy Operations Director, responsibilities include connection with Regional and Country senior stakeholders to determine demand and target audience /focus area. Management of Academy resources and assets to ensure timely and effective delivery, and qualification/quantification of deliverables. Also played key roles in content development, with a specific focus on Strategy and Change Leadership, leadership coaching and behavioral change/changing habits, and numerous lean systems such as VSM and Heijunka, Problem Solving, and Jidoka.

Cambridge, Cambridgeshire, Gb

Astra Zeneca North Ryde continues to be a leading manufacturer of advanced aseptically produced drug products. Reporting to the Director of M&S, and part of the Site Leadership Team, responsibilities include forward-looking leadership involving site strategy refresh and cascade, strategy execution via portfolio management, Lean Six Sigma introduction and culture change, and technical support surrounding sterile manufacturing. Key achievements include; Driving lean transformation to meet benchmarked maturity and performance targets, Development of Strategy Refresh process, Development and management of PMO and Portfolio Governance process, development of sites Contamination control strategy.

Us

GMS - Manufacturer of aseptically produced radiopharmaceutical (SPECT and PET) unit doses. Radpharm - Manufacturer of sterile fill and finish LVP.Reporting directly to the Australian General Manager. Head of GMP Compliance, New Business Introduction and Operations for the Sydney, Brisbane and Perth GMS Aseptic Radiopharmaceutical and Radpharm Sterile Fill and Finish facilities.Played the pivotal role in securing a brownfield site for future facility development, including site selection, development and D&C feasibility, engaging commercial solicitors, town planners, et al through due diligence, etc. Key stakeholder in new facility D&C and critical equipment sourcing. PM for new product for introduction.

Us

GMS - Manufacturer of aseptically produced radiopharmaceutical (SPECT and PET) unit doses. Radpharm - Manufacturer of sterile fill and finish LVP.Reporting directly to the Australian Managing Director. Head of Operations for the Sydney, Brisbane and Perth GMS Aseptic Radiopharmaceutical and Radpharm Sterile Fill and Finish facilities.Played a critical role in the companies enhancement of cGMP (TGA) compliance (provided expertise relating to aseptic processing techniques, facility design, and system and process development. Lead participation in regulatory audits and third party relationships).Managed implementation of COGS reduction and lean initiatives to improve GP. Project Managed a number of business critical projects including site clean room and HVAC renovation, and new ERP system implementation and qualification.

Overland Park, Ks, Us

Manufacturer of terminally and aseptically produced sterile products.Reporting directly to the COO/CFO. Responsible for Parnell Manufacturing operations including; Production, Engineering, Validation and Supply Chain departments (management of resourcing and planning, Opex and Capex budgets, capital works, etc.)Played a critical role in the company's progression from APVMA, to TGA and FDA cGMPs (provided expertise relating to aseptic processing techniques, cleaning methodologies, validation, preventative maintenance, etc. Lead participation in regulatory audits and third party relationships)Management of Manufacturing Capex and Opex Budgets (ensure both operational and capital budgets to plan, and works DIFOT and on budget)Management of process and critical services/utilities/facility upgrades, etc. (HVAC modification/installation, chilled water system upgrade, aseptic filling line development)Value added to many process/systems (increase in capacity with no increase in FTE due to process streamlining, reduction in set-up times due production planning and change over development, JIT manufacturing reducing SOH)

Overland Park, Ks, Us

Reporting directly to the General ManagerResponsible for Parnell Manufacturing Engineering and Validation operationsManagement of validation team and processes including; DQ/IQ/OQ/PQ, process validations, sterilisation validations (both dry and moist heat), cleaning validations, maintenance of the VMP, etc.Management of engineering team and process including; project management, preventative and reactive maintenance, calibration, etc.Management of Engineering and Validation Capex and Opex Budgets

Rutherford, Nsw, Au

Reporting directly to the Operations ManagerResponsible for equipment sourcing and commissioning, management of capital works projects (e.g., new facility development, utilities, etc.), validation practices (such as IQ/OQ/PQ/PV of equipment, process and facility), maintenance of QMS documents including Validation Master Plan, Site Master File, etc.Expertise include; sterilisation validation (autoclave, dry heat oven, GI), air handling system validation (IQ/OQ/PQ), pharmaceutical water system (WFI, RO) IQ/OQ/PQ, management of the Tablet and Powder areas, all factory HVAC, and critical utilities (WFI, RO, etc.), site utilities/services management; waste services, calibration, etc., process and product development technology transfer, scale up and troubleshooting of technical/formulation problems.

Rutherford, Nsw, Au

Development/validation and implementation of analytical/bioanalytical methodsFormulation development and process transferRoutine operation/maintenance of the analytical laboratory, including LCMS (Agilent 1100 LCMSD) and HPLC (Waters Alliance 2690-2695, etc.)Qualitative and quantitative analysis of APIs (in-process, finished product and product development)Product development/formulation

Rutherford, Nsw, Au

Synthesis, quality analysis (in-process, finished product and product development) and stability studies of APIsSynthesis and quantification of degradation/metabolite productsRoutine operation of HPLC (Waters 707/515) system for quality and quantity studiesGeneral laboratory maintenance

Quality analysis of in-coming and out-going product/intermediates including raw and processed dairy productsAnalysis of waste water and products (BOD, Alkalinity, NIR, etc)

Newcastle, New South Wales, Au

Involved the supervision and demonstration of laboratory experiments and techniques to undergraduate studentsThis included all levels of 1st year and 2nd year organic and environmental laboratory practicals

Newcastle, New South Wales, Au

Management of water purifying/filtering systems, including the use of nutrient fixing bacteria and ozone for disinfection, etc.The use of water quality indicators (phosphates, nitrates, DO, alkalinity, etc.)Development of basic aquaculture skillsDevelopment and use of hydroponics for the treatment of waste water

Certificate In Executive And Management Development, General Manager Program, Lean, Finance

Phd, Medicinal Chemistry

B. Sc (Hons); B. En.Sc, Natural Product Chemistry; Chemistry Major