Michael Feuerstein

Michael Feuerstein Email and Phone Number

Manager - Deviation and Nonconformance and CAPA Process Owner @ Astellas Gene Therapies
Fuquay Varina, NC, US
Michael Feuerstein's Location
Fuquay-Varina, North Carolina, United States, United States
Michael Feuerstein's Contact Details

Michael Feuerstein work email

Michael Feuerstein personal email

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About Michael Feuerstein

Results-driven Deviations Manager, Gene Therapy Team Lead, and Human Performance Manager with over 10 years of experience in investigational and leadership related roles. Experience includes biopharmaceutical manufacturing operations and QA deviations management in a startup/tech transfer environment; as well as development of investigations processes in both Veeva and TrackWise QMS; with a focus on organizational resilience, development of robust and compliant deviations management processes and teams, and working with cross-functional teams to proactively refine processes and reduce errors as a means of improving product quality and integrity. Experience encompasses both on-the-floor operations as well as QA leadership and process development, with a focus on risk reduction and proactive process improvement as part of CAPA identification and implementation. My experience in both law enforcement and EMS have given me the skillset and ability to view compliance and investigations from a multi-faceted lens of problem resolution, efficacy verification (necessary when treating patients in a critical care environment, akin to the effectiveness checks used in non-conformance CAPAs to ensure the correct root cause was identified and addressed), providing experience that allows for a more holistic approach to nonconformance resolution and systems.

Michael Feuerstein's Current Company Details
Astellas Gene Therapies

Astellas Gene Therapies

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Manager - Deviation and Nonconformance and CAPA Process Owner
Fuquay Varina, NC, US
Michael Feuerstein Work Experience Details
  • Astellas Gene Therapies
    Manager - Deviation And Nonconformance And Capa Process Owner
    Astellas Gene Therapies
    Fuquay Varina, Nc, Us
    View
  • Astellas Gene Therapies
    Manager - Deviation / Nonconformance And Capa Process Owner
    Astellas Gene Therapies Aug 2022 - Present
    Sanford, North Carolina, United States
    -Business process owner and manager for deviations across both the Sanford, NC site and the SouthSan Francisco, CA site.-Responsible for developing a robust investigations process, management of nonconformance recordsand metrics, investigations team management, and participation in build development of both Veevaand TrackWise quality management systems in a startup environment.-Developed an investigator training program to enhance delivery of compliant and robustinvestigations.-Owned and served as QA approver on critical deviations, significant quality events, productcomplaints, and serious adverse events as it relates to clinical trial production, with a focus on phase appropriate development of processes and procedures.
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  • Pfizer
    Human Performance Manager
    Pfizer Nov 2020 - Aug 2022
    Sanford, North Carolina, United States
    - Site lead for Human Performance related activities, ranging from training colleagues at all levels of Human Performance, Investigational (non-conformance / event) support, conflict resolution, holistic CAPA identification, proactive identification and remediation of potential compliance and error-prone processes, and sitewide Human Error Reduction initiatives.- Sitewide initiatives included the ideation, generation, and implementation of a sitewide Human Performance Analysis based on BPOG principles, CAPA risk ranking tool, initiation of a PHP Champions program, a Leader Observation & Coaching program, Pre/Post Job Briefings, an open-reporting tool for human related near misses, proactive document design, and a sitewide proactive valve signaling project.- Certified as a Pfizer Human Performance Facilitator requiring cross functional involvement in all aspects of sitewide factors that involved any aspect of human interaction with systems, procedures, equipment, and processes through the lens of systemic drivers of human behavior, with a primary
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  • Avexis, Inc.
    Senior Lead Investigator
    Avexis, Inc. Nov 2019 - Nov 2020
    Longmont, Colorado
    - Senior Lead Investigator of a manufacturing support investigations team for a Gene Therapy startup environment involving challenges present both prior to and through the initiation of production activities using a TrackWise based system for non-conformance reporting, metrics, and improvement of Quality Systems.- Responsibilities included team management/workload balance, active work observation, triage of potential deviations, analysis of potential impact/risk to product quality, and authoring of deviations ranging from zero potential product quality impact to critical. Investigations and CAPAs involved all aspects of manufacturing, including upstream operations, downstream operations, supply chain, facilities, documentation, supplier complaints, and training deviations.
  • Pfizer
    Gene Therapy Investigator / Operations Specialist Ii
    Pfizer Oct 2017 - Nov 2019
    Gene Therapy Investigator / Team Lead / Operations Specialist at Pfizer-Quality Deviation Investigator for Gene Therapy manufacturing of Adeno-Associated-Virus based gene therapies (both adherent cell line and large-scale suspension cell lines). Investigations and CAPAs involved all aspects of manufacturing, including upstream operations, downstream operations, fill/finish, documentation, and training deviations.-Served as Team Lead for both Hemophilia and Duchenne Muscular Dystrophy upstream manufacturing teams, including authoring of SOPs and Master Batch Records (MBRs), and served as a focal point of contact for communications between upstream operations and leadership. -Performed Human performance evaluation of processes to champion error-free production and smooth startup of operations leading into GMP activities.
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Michael Feuerstein Skills

Recombinant Dna Research Protein Expression Gmp Teaching Cell Culture Cyclic Voltammetry Dna Electrophoresis Polymerase Chain Reaction Protein Purification Protein Production Sds Page Uv/vis Spectroscopy Biosafety Mammalian Cell Culture Cglp Microsoft Office Dna Extraction Dna Manipulation Dna Recombination Directed Evolution Protein Labeling Protein Chromatography Protein Electrophoresis Protein Assays Gel Electrophoresis Ir Spectroscopy Bacterial Cell Culture Biocatalysis Molecular Biology Biotechnology

Michael Feuerstein Education Details

Frequently Asked Questions about Michael Feuerstein

What company does Michael Feuerstein work for?

Michael Feuerstein works for Astellas Gene Therapies

What is Michael Feuerstein's role at the current company?

Michael Feuerstein's current role is Manager - Deviation and Nonconformance and CAPA Process Owner.

What is Michael Feuerstein's email address?

Michael Feuerstein's email address is mi****@****xis.com

What schools did Michael Feuerstein attend?

Michael Feuerstein attended North Carolina State University, University Of Mount Olive, University Of Mount Olive.

What skills is Michael Feuerstein known for?

Michael Feuerstein has skills like Recombinant Dna, Research, Protein Expression, Gmp, Teaching, Cell Culture, Cyclic Voltammetry, Dna Electrophoresis, Polymerase Chain Reaction, Protein Purification, Protein Production, Sds Page.

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