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Adjoua-Andie E. — Mid-Level Manufacturing Operations Specialist from Location not specified

Adjoua-Andie E.

Mid-Level Manufacturing Operations Specialist

1-2 years
Open to offersNew to Platform
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About

Andie K. is a dedicated Manufacturing Operations Lead based in Santa Ana, CA, with over six years of experience in cGMP-regulated environments. She has a specialized focus in supporting process implementation and developing structured documentation systems for facility startups. Her tenure in the field sees her leveraging tools like SAP and Veeva to enhance inventory visibility and ensure data integrity across manufacturing operations. Andie has a proven ability in creating SOPs, supporting IOQ validation activities, and mapping complex workflows to meet operational requirements. Her professional journey includes critical roles at Avid Bioservices and AstraZeneca, where she contributed to the successful execution of manufacturing processes and compliance alignment. Andie has also played a pivotal role in various capacities including as a Viral Vector Manufacturing Lead and Manufacturing Consultant, where she demonstrated excellence in cross-functional collaboration and continuous improvement initiatives. She holds a B.S. in Chemistry from Radford University, further affirming her technical acumen and commitment to operational excellence.

Experience

  • Upstream Manufacturing Lead

    Avid Bioservices · 2025 — Present
    Supported early-phase facility startup activities, executed IOQ protocol, and reviewed documentation for new manufacturing suites. Developed and controlled SOPs to standardize processes in a new operational environment while drafting User Requirement Specifications (URS) for equipment and materials. Engaged with vendors and internal stakeholders during equipment installation and validation, contributing to process mapping and workflow development to align manufacturing operations with facility capabilities.
  • Viral Vector Manufacturing Lead

    Avid Bioservices · 2024 — 2025
    Executed IOQ protocol and completed documentation review for the new manufacturing suites during facility startup activities. Authored SOPs and controlled documents to establish standardized processes while developing User Requirement Specifications (URS) for manufacturing readiness. Collaborated with internal stakeholders and vendors during the equipment installation and validation phases, aligning workflows with the capabilities of the facility.
  • Manufacturing Consultant (Contract)

    AstraZeneca · 2024 — 2024
    Assisted in manufacturing and operational readiness initiatives within a regulated environment. Reviewed and enhanced process documentation and workflows while collaborating with cross-functional teams to ensure alignment with compliance requirements.
  • Manufacturing Specialist II

    IDT Biologika · 2022 — 2024
    Utilized SAP for supporting inventory tracking, material coordination, and batch execution. Authored and revised SOPs and batch records to comply with cGMP and GDP standards while managing inventory and procurement to maintain material availability. Coordinated team schedules and resource allocation to enhance production workflows, supporting CAPAs, deviations, and continuous improvement initiatives.
  • Cell Therapy Specialist II

    Kite Pharma · 2022 — 2022
    Executed manufacturing processes for cell therapy in a GMP-regulated environment while maintaining accurate documentation to support quality and compliance systems.
  • Manufacturing Associate II / Associate

    MacroGenics, Inc. · 2019 — 2021
    Performed upstream manufacturing processes including cell culture and media preparation while upholding GMP compliance and supporting overall production operations.
  • Production Technician I

    AstraZeneca · 2018 — 2018
    Utilized SAP and LIMS systems for tracking inventory and documentation while performing cleaning and sterilization processes (CIP/SIP) for manufacturing equipment.

Skills & Expertise

Education

  • Bachelor of Science
    Radford University

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