Scott Post Email & Phone Number

Parsippany, 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.

New York, New York, Us

Head 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.

New York, New York, Us

Responsible 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.

New York, New York, Us

Managed 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.

New 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.

New York, New York, Us

Managed 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.

New York, New York, Us

New York, New York, Us

Responsible for Sterility testing.

New York, New York, Us

Responsible for Microbial Limits, Bioburden, Growth Promotion, and Biological Indicator testing.

New York, New York, Us

Responsible for performing in process/release testing and method validation.

Microbiologist for municipal water company responsible for all microbial water testing of potable and raw water samples.

Microbiologist within a contract laboratory.

Ms, Microbiology

Bs, Biology