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Collaborate with the Technical Training Team to ensure business objectives are met through effective learning solutions. Responsible for executing GMP training programs, conducting training sessions, developing training materials, and supporting organizational training initiatives. Focus on continuous improvement of training processes and materials.
Responsible for planning, coordinating, and performing pre-, during, and post-audit activities for assigned audits. Requires extensive knowledge of USA and EU GxP regulations and experience in Quality Management in a GMP environment.
Responsible for configuring, implementing, maintaining, and supporting various IT applications and systems. Collaborate with stakeholders, troubleshoot issues, and provide end-user support. Administer and support production systems efficiently and compliantly. Coordinate with IT developers and analysts to design solutions and perform system administrative tasks.
Supervise and coordinate activities in the Process Sciences department. Support manufacturing processes, provide technical expertise, mentor staff, and drive continuous improvement initiatives. Requires a BS/BEng in relevant fields and 5+ years of experience in pharmaceutical or biotechnology industry.
The Senior Supply Logistics Analyst will ensure compliance and efficiency in the external warehouse network, support special projects, and conduct data analytics impacting the supply chain. Quarterly international travel is required.
Specialize in developing new QC microbiology test methods, providing critical microbiology support to cell-culture, manufacturing, and facilities. Ensure compliance to regulatory guidelines, drive continuous improvements for microbiological methods.
Responsible for planning, coordinating, and performing pre, during, and post-audit activities for assigned audits in GMP, IT, and quality. Collaborate with stakeholders, prepare audit reports, provide guidance on corrective actions, and ensure compliance with industry standards. Requires 50% global travel.
The Senior Project Manager in Process Sciences at Regeneron manages timelines, leads projects, monitors department operations, develops a company-wide and external network, and leverages relationships to enable department objectives.
Senior Manager Accounting responsible for managing the Inventory Accounting team and overseeing inventory and standard cost systems for biopharmaceutical manufacturing operations in Limerick and international entities. Collaborates with corporate accounting departments, handles audits, and ensures internal controls compliance.
Support Process Sciences, Manufacturing, CMC Regulatory, and QA Departments in implementing and maintaining in-process control programs for biologics drug substance and formulated drug substance. Responsibilities include lifecycle activities of established IPC programs, supporting CMC Regulatory Sciences, coordinating interdepartmental discussions, presenting findings, analyzing data, and completing IPC documentation. Requires BSc/BEng with 5 years of experience, MSc/MEng with 4 years of experience, or PhD with relevant experience. Desired cGMP experience.
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