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Within this role you will be working as part of the Manufacturing Team to carry out tasks in line with the production schedule as directed by Team Leads and Supervisors. As an Associate Biotech Production Specialist, a typical shift might include, but is not limited to, the following: Working as part of the Manufacturing team to carry out tasks in ...

Company: Regeneron Ireland DAC (2 weeks ago)

The Senior Process Scientist supports Process Sciences, Manufacturing, CMC Regulatory and QA Departments through activities and documentation related to implementation and maintenance of in-process control programs for the manufacture of biologics drug substance and formulated drug substance. A typical day might include, but is not limited to, the ...

Company: Regeneron Ireland DAC (2 weeks ago)

Summary: Responsible for assisting management with ensuring auditors have the education, experience and/or training necessary to be able to perform audits, and assisting with the maintenance and continuous improvement of the auditor training program. Responsible for planning, coordinating and performing pre-, during and post-audit activities for ...

Company: Regeneron Ireland DAC (2 weeks ago)

This role entails leading more complex and proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization. This position will also serve as a lead Reg Intel contact in support of cross-functional requests and initiatives from the Global ...

Company: Regeneron Ireland DAC (2 weeks ago)

Within this role you will be responsible for managing and overseeing document control and archives operations. This includes oversight of document workflows, records issuance, paper and electronic records archives, inspection support, projects, and metrics. As an Associate Manager Document Control, a typical day might include, but is not limited ...

Company: Regeneron Ireland DAC (2 weeks ago)

Within this role you will be responsible for providing technical leadership and mentorship for qualification activities and data integrity initiatives in regard to small manufacturing and laboratory equipment (e.g. HPLC/UPLC, TOC analyser, FTIR, microscopes) in the frame of Industrial Operations and Product Supply of biological products in ...

Company: Regeneron Ireland DAC (2 weeks ago)

Within this role you will be responsible to specialize in developing new QC microbiology test methods; providing critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. This position may be actively involved in Alternative and Rapid Technologies associated with Microbiological Assays. Ensure ...

Company: Regeneron Ireland DAC Job type: temporary (2 weeks ago)

As a QC Lab Instrumentation Analyst you would support the Quality Control (QC) and Process Sciences (PS) departments by maintaining their laboratory instrumentation in an operational, qualified state. This entails ensuring both instrument hardware and software qualifications are completed in a timely manner and keeping them in a qualified state. A ...

Company: Regeneron Ireland DAC (2 weeks ago)

Within this role you will be responsible in coordinating lab activities and acting as a key point of escalations to ensure seamless operations across shifts. We are seeking a detail-oriented individual who excels in communication, maintains high standards of compliance and GDP, and contributes to process improvements through meticulous research ...

Company: Regeneron Ireland DAC Job type: temporary (2 weeks ago)

Process Sciences is a technical services department that deals with a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. Process Sciences support the following areas; Upstream Sciences, Downstream Sciences, Analytical Technologies, IPC lifecycle, Data Analytics, Manufacturing Support, ...

Company: Regeneron Ireland DAC Job type: temporary (2 weeks ago)

As a Sr. Manager Global Procurement you will support and assist in the development and implementation of the our Global Clinical Category Management strategy by gathering and anticipating business supply needs and specifications. We aim to manage a supply base and enhance value, minimize risk, and ensure quality & cost effectiveness by working ...

Company: Regeneron Ireland DAC (3 weeks ago)

The Associate Director, Safety Scientist in Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases, under the guidance of the safety lead. This will include review, analysis and interpretation of safety data (including aggregate data) to generate appropriate ...

Company: Regeneron Ireland DAC (3 weeks ago)

As aGMP Quality Auditor you will be responsible for planning, coordinating and performing pre, during and post-audit activities for assigned audits. You will be responsible for assessing systems, processes, procedures and records against applicable U.S. and ex-U.S. GxP regulations, with primary emphasis on GMP, IT and quality audits that may impact ...

Company: Regeneron Ireland DAC (3 weeks ago)

The Associate Manager QA is responsible for all aspects of QA Team; provides leadership and support to direct reports and will provide QA oversight for Manufacturing Operations to ensure that drug substance manufacturing activities are compliant with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement ...

Company: Regeneron Ireland DAC (3 weeks ago)

The Senior Manager, Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide guidance and leadership for all aspects of quality and compliance within Global Development Quality (GDQ) systems. The GDQM (GCP) QML will engage with key stakeholders, build strategic partnerships working ...

Company: Regeneron Ireland DAC (3 weeks ago)

Within this role you will be responsible for providing technical support on the manufacturing process. You will be a key member in the implementation of large scale commercial manufacturing production program and heavily involved in the technical transfer of processes. This is a days position. As a Process Specialist Upstream, a typical day might ...

Company: Regeneron Ireland DAC (3 weeks ago)

Working under the Quality Assurance organization this position is responsible for ensuring IT systems, programs and quality events are robust and meet regulatory agency expectations. The position will liaise with the IT and broader QA organizations to ensure all aspects of IT related programs are in compliance with regulatory agency expectations ...

Company: Regeneron Ireland DAC (3 weeks ago)

Within this role you will be responsible for tasks related to the support of manufacturing operations (Large Scale & Sub-Suites); primarily the tracking, collation, analysis and presentation of manufacturing operations data & metrics by liaising with all manufacturing functions and other departments to collate and track relevant data. As an ...

Company: Regeneron Ireland DAC (3 weeks ago)

Within this role you will perform testing to ensure cGMP compliance in the manufacturing facility. You will be responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities. Lead-Related Activities include, but are not limited to, the following: Providing on-the-floor ...

Company: Regeneron Ireland DAC (3 weeks ago)

We are seeking a highly organized and detail-oriented individual to join our Technical Operations department as a Business Process Specialist. In this role, you will be responsible for streamlining and optimizing business processes, with a primary focus on effective department onboarding, personnel development, and communication strategies. A ...

Company: Regeneron Ireland DAC (3 weeks ago)