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Amgen
Apr 30, 2026
Specialist Manufacturing: Process Owner, Manufacturing Services 
Amgen Holly Springs, NC
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...
Amgen
Apr 30, 2026
Specialist Manufacturing New Product Introduction (NPI) - Upstream
Amgen Holly Springs, NC
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. 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 challenges and the opportunities that   lie   within them,   you’ll   thrive as part...
Amgen
Apr 25, 2026
Specialist SAP Analyst – Contract Manufacturing
Amgen United States
Career Category Information Systems Job Description Role Description:   In this vital role you will partner with the EPD (External Planning & Delivery) Business Team to advance and automate day-to-day planning and procurement to accelerate strategy and growth. You will also help build long-term roadmaps for the Ariba Supply Chain Collaboration (SCC) and Sub-Con tracting modules to onboard Direct Suppliers and Contract Manufact ur ers ( CMO’s ) . Support designing and maintaining a vision for how technology can be leveraged to tackle critical business problems, understand the impact of technical solutions on business outcomes and ensure growing the value of investments made. You will collaborate and engage with various partners and help in delivering standard methodology solutions based on business requirements.   We value individuals who have high personal standards of productivity, quality, and ethics. We value people...
Amgen
Apr 25, 2026
R-235089 Quality Assurance Specialist - Manufacturing Support
Amgen Holly Springs, NC
Career Category Quality 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. 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 challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be...
Amgen
Apr 25, 2026
Specialist Manufacturing - DP Production Process Owner
Amgen Thousand Oaks, CA
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...
Amgen
Apr 25, 2026
Manufacturing Execution Systems Specialist
Amgen Thousand Oaks, CA
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-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 challenges...
Madrigal Pharmaceuticals
Apr 24, 2026
Senior Manager, Analytical Manufacturing Science and Technology (MSAT)
Madrigal Pharmaceuticals Conshohocken, PA
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...
AV
Apr 08, 2026
Business Development Manager CMO (Contract Manufacturing Organization) - fulltime, permanent
AbbVie United States
The Business Development Manager will contribute globally to the growth and profitability of AbbVie’s Contract Manufacturing Organization (CMO) by qualifying, driving and executing new business opportunities in Operations Commercial Manufacturing. This individual is also responsible for collaborating with marketing to providing input on the marketing direction of the specific business units by relaying customer feedback and providing industry insights. Key Responsibilities Include: Detail AbbVie CMO's purpose, mission, service offerings, value we offer to our clients and how we fit in the CMO competitive landscape.  Also speak fluently about the business units that they have responsibility for and address common questions posed by customers.  Deliver the site/service presentations over Teams, in-person or at conferences to potential clients at manager/director levels. Respond promptly to inquiries provided by marketing and assess potential manufacturing opportunities for a...
AV
Apr 08, 2026
Business Development Manager (Contract Manufacturing Organization)
AbbVie United States
The Business Development Manager will contribute globally to the growth and profitability of AbbVie’s Contract Manufacturing Organization (CMO) by qualifying, driving and executing new business opportunities in Operations Commercial Manufacturing. This individual is also responsible for collaborating with marketing to providing input on the marketing direction of the specific business units by relaying customer feedback and providing industry insights. Key Responsibilities Include: Detail AbbVie CMO's purpose, mission, service offerings, value we offer to our clients and how we fit in the CMO competitive landscape.  Also speak fluently about the business units that they have responsibility for and address common questions posed by customers.  Deliver the site/service presentations over Teams, in-person or at conferences to potential clients at manager/director levels. Respond promptly to inquiries provided by marketing and assess potential manufacturing opportunities for a...
AV
Mar 19, 2026
Business Development Manager (Contract Manufacturing Organization)
AbbVie United States
The Business Development Manager will contribute globally to the growth and profitability of AbbVie’s Contract Manufacturing Organization (CMO) by qualifying, driving and executing new business opportunities in Operations Commercial Manufacturing. This individual is also responsible for collaborating with marketing to providing input on the marketing direction of the specific business units by relaying customer feedback and providing industry insights. Key Responsibilities Include: Detail AbbVie CMO's purpose, mission, service offerings, value we offer to our clients and how we fit in the CMO competitive landscape.  Also speak fluently about the business units that they have responsibility for and address common questions posed by customers.  Deliver the site/service presentations over Teams, in-person or at conferences to potential clients at manager/director levels. Respond promptly to inquiries provided by marketing and assess potential manufacturing opportunities for a...
re
Nov 09, 2024
Manager Global Procurement - Contract Manufacturing
regeneron Rensselaer, NY
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...
re
Nov 09, 2024
Associate Manufacturing Operations Specialist
regeneron United States
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...
re
Nov 09, 2024
Sr Process Scientist (Manufacturing Support)
regeneron United States
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...
re
Nov 09, 2024
Manufacturing Equipment Specialist / Associate Specialist
regeneron United States
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...
re
Nov 09, 2024
Manager External Manufacturing
regeneron NY
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...
re
Nov 09, 2024
Assoc Manufacturing MES Specialist (Days)
regeneron United States
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...
re
Nov 09, 2024
Manufacturing MES Specialist (Extended Days)
regeneron United States
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...
re
Nov 09, 2024
Production / Manufacturing Operations
regeneron United States
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...
re
Nov 09, 2024
Associate Manager Process Sciences (Manufacturing Support)
regeneron United States
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...
re
Nov 09, 2024
QA Specialist-External Drug Product Manufacturing (Multi Level)
regeneron United States
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...
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