691 manufacturing jobs found

Career Category Operations Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion...

Career Category Operations Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion...

Career Category Manufacturing Job Description Job Summary The Specialist, Manufacturing – AI-Enabled Innovation (IVI) is an individual contributor within the Amgen India Capability Center (AIN), supporting the design, development, and deployment of digital and data-enabled solutions across Amgen’s global manufacturing network. In the initial phase, this role supports manufacturing sites in the deployment of core capabilities, contributing to transition readiness, knowledge transfer, stabilization activities and adoption of new ways of working. In the steady state, this role operates within the Innovation Velocity Interface (IVI), contributing to the end-to-end lifecycle of innovation—from intake and requirements definition through MVP development and scaling. The Specialist brings deep domain expertise in specific manufacturing systems or processes (e.g., MES, finite scheduling, sensing, performance management) and acts as a bridge between manufacturing SMEs and technical...

Career Category Manufacturing Job Description HOW MIGHT YOU DEFY IMAGINATION?   You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.  Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities,...

Career Category Manufacturing Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

Our Regeneron Global Procurement Team is looking for a Manager, Global Procurement supporting the CMO (Contract Manufacturing Organization) space with experience in end-to-end procurement strategies, processes, and global category execution. This Manager will be a part of an amazing team reporting to the Director of Global Procurement - Direct organization. Do you want to be part of something great? Join us! Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, Regeneron's unique ability to translate science repeatedly and consistently into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in Regeneron's laboratories. A typical day might include the following: Leading and working with others to solve issues of diverse scope and provide analysis...

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 Associate Manufacturing Operations Specialist, a typical day might include, but is not limited to, the following: Collating data/KPI metrics from multiple sources both internally & externally (including EHS, HR, QC Finance, QA) for manufacturing operations Compiling the data into charts, spreadsheets and scorecards or other as required Preparing presentations on the compiled data and presents this data; presents at relevant departmental meetings Responsible for the collation and upkeep of all trackers and spreadsheets in relation to headcount resources within manufacturing operations Participating in...

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, Process Validation and Process Solutions. As a Sr Process Scientist in Manufacturing Support a typical day might include, but is not limited to, the following: Supporting delivery of process solutions to IOPS and contributing to best-in-class laboratory and process validation report packages Assisting in root cause analysis of process related deviations using scientific data–driven rationale Participating in cross functional teams to understand process issues in technical and laboratory investigations Contributing to knowledge-based reports summarizing conclusion of studies, investigations and process improvements...

The Manufacturing Equipment Specialist p erforms tasks related to the set-up and start-up of manufacturing operations (Large Scale & Sub-Suites); primarily, the qualification of Manufacturing Small Equipment, review and approval of equipment qualification packages, purchase, delivery & installation of cleanroom furniture and storage, liaising with external vendors, lead / support projects relating to small equipment introduction and qualification. As a Manufacturing Equipment Specialist, a typical day may include, but is not limited to, the following:   Qualifying small equipment by liaising with multiple vendors, reviewing and signing off of qualification packages, completing BMRAM activities including ECN builds and PM event builds for multiple pieces of equipment Generating System Impact Assessments and System Requirement Specifications for new equipment and updating old equipment SRS/ SIA Defining standards, controls and...

We are currently looking to fill a Manager External Manufacturing position. This position strategically leads business relationships and/or facilitates day-to-day operations with Contract Manufacturing Organizations (CMOs) and Partners through the External Manufacturing Team. They will strive to achieve a consistently high level of interaction to meet or exceed Regeneron’s business needs relating to product quality, availability and delivery. They will ensure that all critical external manufacturing requirements are implemented to ensure world-class performance of Industrial Operations & Product Supply (IOPS) product supply chains. The role of the Manager External Manufacturing is to act as the Relationship Lead with the CMO/Partners or as the Operations Lead within the External Manufacturing Teams. In this role, a typical day might include the following: Ensuring that product manufacture occurs in compliance with cGMP and applicable regulations. Facilitates all...

Within this role you will be responsible for leading the deployment and support of the Manufacturing Execution Systems (MES), Manufacturing Batch Records (MBRs), Generic Manufacturing Batch Records (GMBRs) and Equipment data. As a Manufacturing MES Specialist a typical shift might include, but is not limited to, the following: Chair reviewing and approving sessions of MES project deliverables against the overall project plan MES Design Spec reviewing using the MR/BS and completed design spec/process flow map templates Populating and completing review of MES documentation such as Config Spec (MESCS) and Trace Matrices (TMs) Leading Pre-PE executions (Static and Dynamic) and testing of MES records Coordinating team on plant testing (Shakedowns) of MES documents with MFG SME Coordinating team and documentation of all testing protocol and ensure GDP and compliance Coordinating of Workflows for documentation approval Reviewing of data for build of OPM...

Within this role you will be responsible for leading the deployment and support of the Manufacturing Execution Systems (MES), Manufacturing Batch Records (MBRs), Generic Manufacturing Batch Records (GMBRs) and Equipment data. This is an extended days position. As a Manufacturing MES Specialist a typical shift might include, but is not limited to, the following: Chair reviewing and approving sessions of MES project deliverables against the overall project plan MES Design Spec reviewing using the MR/BS and completed design spec/process flow map templates Populating and completing review of MES documentation such as Config Spec (MESCS) and Trace Matrices (TMs) Leading Pre-PE executions (Static and Dynamic) and testing of MES records Coordinating team on plant testing (Shakedowns) of MES documents with MFG SME Coordinating team and documentation of all testing protocol and ensure GDP and compliance Coordinating of Workflows for documentation approval...

Within a manufacturing function you will be performing tasks supporting the manufacturing operations of both clinical and commercial manufacturing programs at Regeneron Ireland. Working a shift pattern in a fully gowned, cleanroom environment, a typical shift might include, but is not limited to, the following: Working as part of the Manufacturing team to carry out tasks in line with the production schedule as directed by Team Leads and Supervisors Ensuring all associated documentation such as manufacturing batch records & logbooks are completed, accurate and verified in accordance with SOPs and cGMP Standards Performing equipment cleaning, preparation and execution as well as completing associated documentation Adhering to safety and GMP (Good Manufacturing Practice) requirements at all times when carrying out tasks Performing various tests and in-process sampling Maintaining housekeeping in designated area and adhering to the hygiene standards of the...

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, Process Validation and Process Solutions.   As an Associate Manager within Process Sciences Manufacturing Support a typical day might include, but is not limited to, the following: Understanding and communicating the big and small picture in order to drive strategic plans. Co-ordinating the provision of technical support to the manufacturing process. Coaching, mentoring and develop staff, including overseeing new employee onboarding and providing career development planning and opportunities. Communicating business and organizational information/priorities and ensure appropriate allocation of resources. Developing strong...

The QA Specialist/Sr QA Specialist for External Drug Product Manufacture provides QA oversight to ensure that drug product manufacturing activities are compliant with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. A typical day might include, but is not limited to, the following:   Reviewing and approving the following document types, relating to area functions: Master records, Executed records, Failure investigations, Change Control & Partner Notifications, Standard Operating Procedure (SOPs) Coordinating QA resource assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management Providing governance/performing compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions Representing Quality Assurance both internal to Regeneron and External with Partners and Contract Manufacturers in...

Within this role you will be facilitating and coordinating manufacturing data entry, manufacturing logbooks management, documents tracking systems and perform record related activities for manufacturing. As a Temp Manufacturing Data Entry Associate, a typical day might include, but is not limited to, the following:   Entering information into departmental databases Liaising with Document Control and Manufacturing teams to request manufacturing logbooks in advance of being required Performing intake review of manufacturing documents for completeness and accuracy Facilitating and cataloging manufacturing documentation, manufacturing records, batch sheets and logbooks Being responsible for ensuring documentation timelines are met through effective communication and follow through with document owners Coordinating document movement across all functional groups Implementing and maintaining document repositories Preparing routine progress reports on...

In this role you will be responsible for providing QA oversight and support to manufacturing activities.  Performs and leads activities in support of dispositioning product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. The successful candidate will be required to work shift which includes a mix of days & nights As a QA Specialist a typical shift might include, but is not limited to, the following: Providing QA oversight & support to manufacturing activities within the manufacturing areas to support: Issue resolution in conjunction with key stakeholders, including:  Quality point-of-contact for troubleshooting and documentation of equipment/process/schedule disruptions, Triage of potential non-conformances including securing necessary documentation for investigation team in real-time, Support of/counter signing annotations, Perform area walkthroughs, Provide oversight and...

We are currently looking to fill a Principal External Manufacturing Specialist role. The External Manufacturing Principal Specialist provides technical and process support for all aspects of clinical and commercial parenteral drug product operations in the External Manufacturing Network. Coordinates all aspects of manufacturing operations including oversee day-to-day operations, ensure timely completion of associated operations/documentation, and assist in the monitoring of cGMP compliance at drug product contract manufacturers.   As a Principal External Manufacturing Specialist, a typical day may include the following: Serve as the primary Regeneron technical contact for select DP contract manufacturing sites concerning day-to-day activities. Liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners. Ensure the timely routing and review of all master manufacturing records...

Within this role you will be responsible for the administration, configuration, implementation, maintenance and ongoing support of various manufacturing equipment specific applications and systems in a cGMP environment. As an Automation Engineer a typical day might include, but is not limited to, the following: Providing end-user support for small manufacturing equipment applications including troubleshooting issues and appropriately communicating items to management, business process owners and users Working on equipment ranging from standalone equipment such as UV Specs, pH meters, particle samplers to networked equipment such as wave rockers, chromatography skids and cell analysers Overseeing and execution of automation preventative maintenance activities Being responsible for generating automation documentation such as SOPs, work instructions and configuration specification documents Performing daily business administrative tasks related to functional...