Greg Parry, PhD, PMP

Experience

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  Watson/Actavis

  Mar 2003 - Sept 2014

  Associate Director Project Management

  Project Management responsibilities included developing and maintaining project plans and budgets. Managed multi-functional project teams that developed products encompassing CMC and Phase 1 through Phase 3 clinical development programs through NDA submission. Managed team that successfully developed and obtained NDA approval for Rapaflo. Led site implementation of project management enterprise software; Planisware and Planview.Led several generic development projects from CMC development through ANDA submission. Show less

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  Lipocine Inc.

  Sept 2014 - Dec 2015

  Executive Director, Portfolio and Project Management

  Reviewed and wrote Tlando NDA sections (oral testosterone product). NDA was accepted for review by FDA.Initiated and managed a Quality Assurance unit to ensure internal and external vendor quality compliance.Project Management responsibilities included developing and maintaining project plans and budgets to meet company goals for 3 pipeline projects. Managed external vendor selection and subsequent activities for Phase 1 through Phase 3 clinical studies.

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  Intarcia Therapeutics, Inc.

  Feb 2016 - Oct 2020

  Senior Director, Process Development & Engineering

  Manage process engineering group to develop, optimize, and validate a complex GMP process to aseptically manufacture drug-device combination products. Lead difficult Deviation Investigations and associated CAPAs.Wrote and reviewed CMC sections for NDA submission and resubmission. Developed strategies and executed experimental programs to address NDA review, CRL, and PAI questions. Participated in PAI preparation and inspection.

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  Bayer

  Oct 2020 - Nov 2022

  Director Formulation & Device Mgm

  Focus on developing cell therapy drug product formulations and processing

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  Pyxis Oncology

  Nov 2022 - Nov 2023

  Director of CMC Project Management

  Project Manager and Drug Product Technical Lead for early stage CMC oncology projects

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  WF Engineering

  Mar 2024 - now

  NDT Manager