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Amgen
Feb 18, 2026
Specialist Manufacturing New Product Introduction (NPI)
Amgen Holly Springs, NC, USA
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
Jan 26, 2026
Specialist-Manufacturing Investigations
Amgen Holly Springs, NC, USA
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 part...
Amgen
Nov 22, 2025
Specialist Manufacturing: NPI, Upstream Process Owner
Amgen Holly Springs, NC, USA
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 lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career....
Amgen
Nov 22, 2025
Specialist Manufacturing: NPI, Process Owner
Amgen Holly Springs, NC, USA
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 lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career....
re
Nov 09, 2024
Sr Process Scientist (Manufacturing Support)
regeneron USA
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
Associate Manager Process Sciences (Manufacturing Support)
regeneron USA
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
Automation Engineer -Small Manufacturing Equipment
regeneron USA
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...
re
Nov 09, 2024
Associate Director/Director of Technical Operations (Process Equipment Engineering & Maintenance)
regeneron USA
The Associate Director/Director of Technical Operations is responsible for leading the Biopharmaceutical Process Equipment Engineering & Maintenance teams with management responsibilities of direct employees, contractors and specialist vendors involved in supporting GMP manufacturing operations and maintenance. This individual will provide technical leadership, drive operational excellence, and foster a culture of safety, collaboration, and continuous improvement. A strong emphasis will be placed on quality and compliance, people management, team development, leadership, and succession planning. Essential Duties and Responsibilities include, but are not limited to, the following: Leading and the management of the process equipment engineering, maintenance, and calibration teams.  Providing engineering and technical support to manufacturing operations with specific focus on system and equipment continuous improvement. Owning the introduction of new process...
Amgen
Feb 19, 2026
Specialist QC
Amgen Holly Springs, NC, USA
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
Feb 11, 2026
Case Management – Specialist (Device Safety)
Amgen USA
Career Category Information Systems 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...
Amgen
Feb 02, 2026
Specialist QA, Global Supply Quality
Amgen USA
Career Category Quality Job Description ABOUT AMGEN   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.   Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.  ABOUT THE ROLE   In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations.   You will make key contributions to ensure high quality and right first time materials are received at...
Amgen
Jan 15, 2026
Specialist QA TS
Amgen USA
Career Category Quality Job Description Specialist – QA Technical Support NPI Live    What you will do    Let’s do this. Let’s change the world.  Amgen discovers, develops, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.  The Quality Assurance Technical Support Specialist NPI (New Product Introduction) is a senior position within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of...
Amgen
Dec 03, 2025
Specialist Business Analyst (Pi Data Historian)
Amgen USA
Career Category Information Systems Job Description Job Description – Specialist Information Systems (OSI Pi Data Historian) ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller, and longer. We discover, develop, manufacture, and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Title: Specialist Information Systems (Pi Data Historian) Location: Amgen India Role Description The Specialist Information Systems (Pi Data Historian) is responsible for owning, administering, and providing technical leadership for OSI Pi and related Manufacturing Information Systems in a GMP-regulated environment. The role focuses on integration with process equipment and...
Amgen
Sep 02, 2025
Product Quality Specialist
Amgen USA
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....
Amgen
Feb 02, 2025
Case Management – Specialist (Device Safety)
Amgen USA
Career Category Medical Services 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....
Amgen
Dec 03, 2024
Specialist CMC Statistician
Amgen USA
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....
Amgen
Dec 02, 2024
Product Quality Specialist
Amgen USA
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....
re
Nov 09, 2024
Process Specialist Downstream
regeneron USA
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 shift position, including day and night shift.  As a Process Specialist Downstream, a typical day might include, but is not limited to, the following: Liaising with the process science/technology transfer teams in relation to the transfer and startup of the downstream manufacturing process Being the key person for technical input into manufacturing records, batch sheets and procedures Writing and reviewing, Standard Operating Procedures or other controlled documents as needed Providing technical input to resolve process problems both on and off the production suites Working closely with other cross functional groups such as Maintenance, Process Sciences, Engineering to resolve...
re
Nov 09, 2024
Executive Director Quality Control
regeneron Rensselaer, NY, USA
We are looking to add an Executive Director Quality Control to our team in Rensselaer, NY! This role leads activities in Quality Control, including but not limited to: release and in-process testing, stability testing, lab investigations, manufacturing failure investigations, environmental monitoring and microbiological testing. Providing comprehensive testing support to clinical and commercial manufacturing, regulatory inspections, filing and facility operations. Leading operational and technological collaboration between the QC group and its business partners. In this role, a typical day might include the following: Leading a full scale of QC operation to support production, facility and cGMP compliance. Providing broad experience and guidance for biopharmaceutical quality control and analytical testing. Interpreting scientific data and draw reasonable conclusions. Advising manufacturing, QA, RA, facilities and material management of quality control requirements and...
re
Nov 09, 2024
Senior Process Scientist
regeneron USA
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 following: Carrying out lifecycle activities of established IPC programs for manufacturing bioprocesses including impact assessment both on a site specific and global level, change control, and document generation or revision Supporting CMC Regulatory Sciences in development and writing of responses for technical sections of regulatory documents Facilitating and coordinating interdepartmental discussions in support of Process Sciences validation and IPC activities Presenting findings, limit setting and re-evaluation strategies at group, departmental, and interdepartmental meetings as required. Collating and analysing data...
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