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Skilled Leader with proven expertise and success in managing Quality Assurance, Quality Control, and Aseptic Operations. Results-oriented manager working with Biologics, Vaccines, and Oncology products at a site and global level. Possess strong people and analytical skills with ability to work independently and effectively in a team and global setting. I have held several management positions with increasing responsibilities within Microbiology and Quality Assurance. Key capabilities:-Strong Sterility Assurance/Microbiology, Aseptic Operations, Laboratory Operations, Quality, and Compliance background.-Solid aseptic manufacturing and contamination control background.-Experience working with sterile injectable products. I also have experience working with Consumer products in the tablet and liquid form.-Worked on 2 Oncology products through clinical phase to commercial launch. These products were successfully launch in US and EU, as well as several other countries in 2017 and 2018.-Experience with Consent Decree remediation activities.-Extensive knowledge in the following testing areas:Sterility, Bioburden, Endotoxin, Water, Microbial Limits, Cell bank, Microbial Identifications, Growth Promotion, Biological Indicators, Environmental Monitoring, and Stability.-Ability to lead cross functional and global network teams.-Project Management-Drive the implementation/harmonization of Quality Standards, Global Procedures, and best practices across global network.
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Global Aseptic Support LeaderZoetis Inc. Mar 2019 - PresentParsippany, Nj, Us-Global Subject Matter Expert (SME) for aseptic manufacturing.-Provide leadership and guidance for aseptic manufacturing and microbiology operations to the platforms in the Global Manufacturing and Supply organization.-Leader of the Global Aseptic Network team.-SME for inquiries related to aseptic operations and aseptic operation regulations.-Collaborate with sites to ensure alignment with regulatory requirements and establish action plans to ensure compliance.-Support regulatory inspections at the sites. -Provide support in writing responses to regulatory observations related to aseptic operations.-Global Program Leader to identify and implement alternative sterilization technologies for the Zoetis portfolio of products and materials.-Created new Quality Standards and Global Procedures for Aseptic Operations.-Responsible for providing technical support and guidance to network sites and CMOs for contamination related investigations.-Collaborated and developed a new Environmental Monitoring investigation record.-Evaluate and implement new technology associated with aseptic processing. -
Microbiology Lead-OncologyPfizer Jan 2016 - Feb 2019New York, New York, UsHead of Microbiology Laboratory Operations and the Aseptic Performance Team in the Antibody Drug Conjugate organization at the Pearl River site.-Member of the Site Quality Leadership Team.-Active participation in 6 successful PAIs conducted in 2017 and 2018.-Developed PAI and inspection readiness plans for the Microbiology Laboratory.-Responsible for writing responses related to Inspections and Regulatory queries.-Led the implementation of Visual Management boards, 5S activities, and Standard work in the laboratory.-Updated/Verified Regulatory Submission documents in support of Commercial filings.-Responsible for the site Environmental Monitoring program.-Oversaw the Stability and Reserve program for Clinical and Commercial Oncology products. -
Site Transition LeadPfizer Aug 2015 - Jan 2016New York, New York, UsResponsible for the management of the Quality Systems transfers to network sites in support of the exit of Biotech manufacturing operations at the Pearl River site. -
Manager, Quality OperationsPfizer Aug 2013 - Jan 2016New York, New York, UsManaged the Stability program for Clinical and Commercial Operations at the Pearl River, NY site.Some key areas of responsibility are listed below:-Supported Regulatory Submissions for Clinical and Commercial products across the Pfizer global network.-Provided Stability Assessments for shipping/field excursions and product complaints.-Site Lead for the Lean Stability program across the Pfizer global network.-Performed Site Quality Approval on investigations, commitments, and procedures.-Member of the Site Quality Review Team.-Responsible for the development of departmental goals and development plans for direct reports.-Assisted in evaluating and preparing the departmental budget providing recommendations for headcount, and salary increases. -
Sr. Manager (Associate Director), Quality Control Laboratory OperationsPfizer Sep 2014 - Dec 2014New York, New York, Us-Provided support to the Microbiology and Medical Devices groups within Quality Control. -Consolidated the Stability program for Commercial and Development products. -Completed gap assessments on Pfizer Quality Standards.-Reviewed and approved Laboratory and Manufacturing Investigations. -
Sr. Manager (Associate Director)-Laboratory OperationsPfizer Nov 2010 - Aug 2013New York, New York, UsManaged all Microbiological raw material, in process, and release testing supporting the Biotechnology, Consumer Healthcare, Oncology, and R&D Business units at the Pearl River, NY site. Some key areas of responsibility are listed below:-Team Lead for implementation of Lean Laboratory concepts which realized a cost savings of 30%. Responsible for driving Lean Laboratory transformation, sustainability, and continuous improvement activities such as Key Performance Indicators, Kaizens, and Gemba walks. -Site Lead for Microbiological method standardization across the Legacy Wyeth Biotechnology global network.-Pearl River site liaison for contract laboratory testing in support of operations.-Pearl River site representative on several Pfizer global network teams.-Responsible for method verification/validation activities within the department.-Managed the Change Control activities for methods and equipment within the department. -
Microbiology Manager-Sterility AssurancePfizer Oct 2005 - Nov 2010New York, New York, Us -
Sr. SupervisorPfizer 2004 - 2005New York, New York, UsResponsible for Sterility testing. -
SupervisorPfizer 2003 - 2004New York, New York, UsResponsible for Microbial Limits, Bioburden, Growth Promotion, and Biological Indicator testing. -
MicrobiologistPfizer 2001 - 2003New York, New York, UsResponsible for performing in process/release testing and method validation. -
MicrobiologistPassaic Valley Water Commission 1998 - 2001Microbiologist for municipal water company responsible for all microbial water testing of potable and raw water samples.
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MicrobiologistSgs Us Testing 1997 - 1998Microbiologist within a contract laboratory.
Scott Post Skills
Scott Post Education Details
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Seton Hall UniversityMicrobiology -
University Of HartfordBiology
Frequently Asked Questions about Scott Post
What company does Scott Post work for?
Scott Post works for Zoetis Inc.
What is Scott Post's role at the current company?
Scott Post's current role is Global Aseptic Support Leader at Zoetis Inc..
What is Scott Post's email address?
Scott Post's email address is br****@****aol.com
What is Scott Post's direct phone number?
Scott Post's direct phone number is (212) 733*****
What schools did Scott Post attend?
Scott Post attended Seton Hall University, University Of Hartford.
What skills is Scott Post known for?
Scott Post has skills like Aseptic Processing, Gmp, Change Control, Microbiology, V&v, Environmental Monitoring, Lims, Cleaning Validation, Pharmaceutical Industry, Fda, Sterility Assurance, Biotechnology.
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