7 manufacturing jobs found

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 assigned audits. Extensive knowledge of USA and EU GxP regulations is required. Essential Duties and Responsibilities include, but are not limited to, the following: Maintain professional expertise and knowledge of audit criteria including, but not limited to, internal company policies and procedures, and applicable local and international regulations, standards and guidelines (e.g., Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards, and ICH, WHO and IPEC Guidelines, etc.); Monitor industry trends with respect to regulatory agency findings, expectations and warning letters;...

The Senior Manager Accounting will be responsible for management of the Inventory Accounting team based in Limerick in connection with the Company’s biopharmaceutical manufacturing operations in Limerick and International entities. A typical day might include, but is not limited to, the following:  Reporting of monthly actual results for inventory for the international entities Responsible for Profit in Inventory Elimination for international entities Reviewing and handling the company’s inventory and standard cost system including annual standards' development Reviewing and maintaining company’s inventory and standard cost system Oracle Process Manufacturing Working with Master Data Management to ensure production Recipes / BOM’s are accurate and are reflected in the Standard Costing calculations Reviewing Sub Ledger (Production, Inventory, Purchasing, Revaluation, Order Management) Responsible for coordination and review of quarterly inventory...

Within this role 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 Regeneron operations and/or product. Note this position requires approximately 50% travel globally. As a GMP Quality Auditor, a typical day might include, but is not limited to, the following:   Maintaining professional expertise and knowledge of audit criteria including internal company policies and procedures, and applicable local and international regulations, standards and guidelines (e.g., Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards, and ICH, WHO and IPEC Guidelines, etc.) Supervising industry trends with respect to regulatory agency findings, expectations and...

As a GMP Quality Auditor you will be r esponsible 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 Regeneron operations and/or product. A typical day might include, but is not limited to, the following:   Maintaining professional expertise and knowledge of audit criteria including, but not limited to, internal company policies and procedures, and applicable local and international regulations, standards and guidelines (e.g., Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards, and ICH, WHO and IPEC Guidelines, etc.) Supervising industry trends with respect to regulatory agency findings, expectations and warning letters Performing supplier/external audits and...

We are currently looking to fill a Staff Accounting position. In this role, the Staff Accountant p rovides accounting analysis, reconciliation, and schedule support for a variety of areas, including labor reporting, fixed assets, intercompany and collaboration activities, in connection with the Company’s biopharmaceutical manufacturing operations. With the ongoing expansion of Regeneron, including its manufacturing operations, we are seeking an individual to contribute to a growing and dynamic environment. In this role, a typical day might include the following: Responsible for various accounting-related tasks in connection with the Company’s collaboration agreements, intercompany activities, Contract Manufacturing Organizations (“CMO”), and COGS. Ownership of assessing and accounting for financial impacts of CMO service commitments. Supports development of inventory standard costs, including external CMO rates Collaborate with personnel from various other...

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative ways to science, manufacturing, and commercialization, as well as redefining our understanding of health. Senior Specialist – Contracting Global Procurement Capability Centre in Bengaluru will be an individual contributor and supporting the contracting capabilities within a newly formed Capability center to enable delivery of Global Procurement responsibilities at Regeneron. The role will be demonstrating a systemic approach for buying goods and services while applying procurement applications to provide efficient and effective contract execution. The role will maintain consistency, scalability and efficiency for repeatable, location agnostic contracting across...

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative ways to science, manufacturing, and commercialization, as well as redefining our understanding of health. Senior Specialist – Contracting Global Procurement Capability Centre in Bengaluru will be an individual contributor and supporting the contracting capabilities within a newly formed Capability center to enable delivery of Global Procurement responsibilities at Regeneron. The role will be demonstrating a systemic approach for buying goods and services while applying procurement applications to provide efficient and effective contract execution. The role will maintain consistency, scalability and efficiency for repeatable, location agnostic contracting across...