Austin Mcdonald Email and Phone Number
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With 36+ years in the pharmaceutical industry, Austin has extensive operations management, regulatory and process engineering experience in the EU, USA and Asia. Austin’s specialist areas are facility implementation, product development, product commercialization, strategic planning and regulatory & quality systems. Austin is a recognized subject matter expert in barrier isolator systems, steam sterilization, sterile component handling, sterile filling of vials & syringes, lyophilizers & loading systems, automated inspection systems and the handling of complex materials including, cytotoxic substances, carcinogenic substances, biological hazards and radioactive pharmaceuticals. In addition to speaking at numerous conferences on aseptic processing and barrier isolation technology, Austin is a past Adjunct Professor at Stevens Institute of Technology, NJ, where he lectured on GAMP (Good Automated Manufacturing Practices) documentation, project management and the design and implementation of aseptic processes.
Sterile Technology Llc
View- Website:
- steriletechllc.com
- Employees:
- 9
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Managing PartnerSterile Technology Llc Jan 2010 - PresentWilmington, Delaware, Usa.Sterile Technology is a sterile process engineering consulting company serving the pharmaceutical, biotechnology and medical device industries. As Managing Partner Austin provides executive management and consulting services to clients in the US, EU and Asia.
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Ceo, OncogenerixOncogenerix Mar 2016 - Mar 2020ChinaAs CEO, General Manager and Legal Representative for Mudanjiang OncoGenerix Co., Ltd. in China, Austin reported to the Board of Directors and was responsible for the following activities:- Leading the executive management team.- Assisting in the preparation and implementation of the business strategy.- Preparing and maintaining budgets.- Ensuring that all required non GMP site approvals (e.g., property licenses, work safety, occupational diseases, site development plan… Show more As CEO, General Manager and Legal Representative for Mudanjiang OncoGenerix Co., Ltd. in China, Austin reported to the Board of Directors and was responsible for the following activities:- Leading the executive management team.- Assisting in the preparation and implementation of the business strategy.- Preparing and maintaining budgets.- Ensuring that all required non GMP site approvals (e.g., property licenses, work safety, occupational diseases, site development plan, environmental impact assessment, etc.) were obtained and maintained.- Ensuring compliance with global regulatory requirements for the FDA, EMA, and NMPA and implementing the strategies to obtain required regulatory approvals based on business objectives. - Managing the legal representative responsibilities and ensuring compliance with the laws of the Peoples Republic Of China. Show less -
Director Of Operations, OncogenerixOncogenerix Jun 2014 - Mar 2016ChinaAs Director Of Operations, Austin managed the day to day activities for the site, led the resource engagement for the Quality Operations and Site Operations teams, managed facility qualification and implemented the product and process validation strategy to obtain site regulatory approvals. As Director of Operations, Austin was responsible for the following departments: - Manufacturing (Component Prep / Formulation / Filling / Inspection / Labeling / Materials Management).- Engineering… Show more As Director Of Operations, Austin managed the day to day activities for the site, led the resource engagement for the Quality Operations and Site Operations teams, managed facility qualification and implemented the product and process validation strategy to obtain site regulatory approvals. As Director of Operations, Austin was responsible for the following departments: - Manufacturing (Component Prep / Formulation / Filling / Inspection / Labeling / Materials Management).- Engineering (GMP & Commissioned Utility Systems / Electrical Services /Equipment & Facility - Maintenance / PMs / Calibration / New Project Implementation).- Validation (Formulation / Filling / Inspection / Labeling & Packaging / GMP Utility Systems).- Technical Transfer (TT Development Plans / Bench Studies / Formulation / Filling / Inspection / Packaging).- Administration (Administration / HR / Security / Training / IT / Translation / Transportation).- Accounting (Purchasing / Accounts Payable / Account Receivables). Show less
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Consultant, OncogenerixOncogenerix Jan 2011 - Jun 2014As a consultant for OncoGenerix, Austin supported the design, construction, commissioning and qualification of the OncoGenerix facility in Hailin China (total site area of 39,600M2).
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Adjunct ProfessorStevens Institute Of Technology Jan 2007 - Dec 2015Hoboken, Nj, Usa.Adjunct Professor in the Masters Program at Stevens Institute Of Technology. Lecturing on a systematic risk based methodology for implementing GMP processes including how the methodology integrates the preliminary design, detailed design, construction and validation phases of a project to minimize the challenges, cost and schedule overruns typically associated with implementing complex GMP processes. The PME643 lectures cover the following:- Introduction to the elements of an aseptic… Show more Adjunct Professor in the Masters Program at Stevens Institute Of Technology. Lecturing on a systematic risk based methodology for implementing GMP processes including how the methodology integrates the preliminary design, detailed design, construction and validation phases of a project to minimize the challenges, cost and schedule overruns typically associated with implementing complex GMP processes. The PME643 lectures cover the following:- Introduction to the elements of an aseptic process.- Review of typical project steps.- The project team & GMP project management.- The capacity analysis.- Preparation of the validation master plan & the process description.- Review of the key project documentation.- Preparing the user requirements specification.- Preliminary design, budget & schedule.- Preparing equipment procurement packages & equipment procurement.- Completing the equipment & facility detailed design.- Equipment & facility construction.- Vendor internal testing & factory acceptance testing.- Equipment installation, commissioning & site acceptance testing.- Equipment qualification and process validation.- Operator training, SOP writing & key project risks. Show less -
Dir OperationsMedefil, Inc. Mar 2010 - Mar 2014Glendale Heights, Il, Usa.Director of Operations for Medefil a device and drug manufacturing company, with the following responsibilities:- Manufacturing (Component Prep / Formulation / Filling / Inspection / Labeling / Materials Management).- Process Utilities (GMP & Commissioned Utility Systems / Electrical Services).- Engineering (Equipment & Facility Maintenance / PMs / Calibration / New Project Implementation).- Validation (Formulation / Filling / Inspection / Labeling & Packaging / GMP Utility… Show more Director of Operations for Medefil a device and drug manufacturing company, with the following responsibilities:- Manufacturing (Component Prep / Formulation / Filling / Inspection / Labeling / Materials Management).- Process Utilities (GMP & Commissioned Utility Systems / Electrical Services).- Engineering (Equipment & Facility Maintenance / PMs / Calibration / New Project Implementation).- Validation (Formulation / Filling / Inspection / Labeling & Packaging / GMP Utility Systems).- Product Development (Development Plans, Bench Studies, Formulation, Filling [Aseptic & Terminal Sterilization], Inspection & Packaging). Show less -
CooIsogen Llc 2008 - 2010Wilmington, De, Usa.Chief Operating Officer for Isogen a small scale CMO for potent / non potent sterile products with the following responsibilities:- Product Technology (Tech Transfer / Customer Project Management).- Manufacturing (Component Prep / Formulation / Filling / Inspection / Labeling / Materials Management).- Laboratory Services (Chem Lab / Micro Lab / Material Sciences).- Engineering (Facility Maintenance / PMs / Calibration / New Project Implementation).
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Sr Engineer / Managing PartnerGl Engineering Oct 1998 - Dec 2008Livingston, Nj, Usa.Managing partner for GL Engineering a sterile process engineering consulting company serving the pharmaceutical, biotechnology and medical device industries with responsibility for the following project activities on behalf of Clients:- Design (master planning, concept design & detailed design)- Contract Management: (procurement, scheduling, construction management, startup & commissioning).- Validation: (equipment qualification & process validation).- Compliance: (audits… Show more Managing partner for GL Engineering a sterile process engineering consulting company serving the pharmaceutical, biotechnology and medical device industries with responsibility for the following project activities on behalf of Clients:- Design (master planning, concept design & detailed design)- Contract Management: (procurement, scheduling, construction management, startup & commissioning).- Validation: (equipment qualification & process validation).- Compliance: (audits, quality management systems & regulatory compliance corrective actions).- Facility staffing.- Product technical transfer. Show less
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Dir, Barrier TechnologyJohn Brown Engineering Apr 1995 - Oct 1998Bridgewater, Nj, Usa.Managed the Barrier Isolation group at John Brown Engineering.
Austin Mcdonald Skills
Frequently Asked Questions about Austin Mcdonald
What company does Austin Mcdonald work for?
Austin Mcdonald works for Sterile Technology Llc
What is Austin Mcdonald's role at the current company?
Austin Mcdonald's current role is Managing Partner Sterile Technology LLC.
What is Austin Mcdonald's email address?
Austin Mcdonald's email address is au****@****inc.com
What is Austin Mcdonald's direct phone number?
Austin Mcdonald's direct phone number is +197349*****
What skills is Austin Mcdonald known for?
Austin Mcdonald has skills like Validation, Gmp, Pharmaceutical Industry, Aseptic Processing, Quality System, Fda, Technology Transfer, Process Engineering, Manufacturing Operations, Manufacturing, Biotechnology, Capa.
Who are Austin Mcdonald's colleagues?
Austin Mcdonald's colleagues are Long Zhao, Charlie Gallagher.
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4yahoo.com, mcdco.com, genezenenergy.com, amoveforlife.org10 +181845XXXXX
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2rockets.utoledo.edu, owenscorning.com3 +141924XXXXX
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Austin McDonald
Associate Director Of Forensics & Associate Professor Of Communication Studies At Hastings CollegeHastings, Ne3lsu.edu, hastings.edu, hastings.edu1 +133459XXXXX
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1usm.edu2 +160126XXXXX
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Austin McDonald
Atlanta, Ga2mcdonalddevco.com, mcdco.com3 +140492XXXXX
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