23 information technology jobs found

Career Category Quality Job Description Role Overview The Indirect Plant Technical Quality Assurance (QA) Specialist is a key role within the QA function, responsible for providing expert quality oversight and guidance across critical processes. This position requires subject matter expertise in assigned areas and the ability to operate across functional boundaries to ensure compliance with GMP and internal standards. Key Responsibilities Act as QA representative at Change Control and Deviation Review Boards, providing quality direction and input. Assume QA oversight of change control and deviation/CAPA records, ensuring clear scope and robust, timely implementation activities. Review and approve validation documentation and SOPs to support site validation activities as required. Provide input into Annual Product Reviews (APRs). Support a safe working environment by complying with all environmental health and safety practices, rules, and regulations. Perform...

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...

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...

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....

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....

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...

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....

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...

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...

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....

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...

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...

Within this role you will be responsible to provide key technical support for internal and external technology transfer of biopharmaceutical drug substance manufacturing processes for monoclonal antibodies/therapeutic proteins and provide post transfer support. This is a 12-month temporary contract As a Temp MSAT Specialist, a typical day will include, but is not limited to, the following: Assessing manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities Generating facility fit assessments and high-level gap assessments Generating and reviewing documentation supporting technology transfer (e.g., master plans and reports, process descriptions, memos, detailed gap assessments) Presenting options to resolve technical challenges and seeking endorsement Analysing process-generated data; summarizing findings in memos, reports, and presentations Reviewing manufacturing documentation generated...

We are seeking an Associate Scientist to join our Non-viral Delivery Technology group and support screening potent and tolerable gene delivery modalities. As a part of Regeneron Genetics Medicine, this work would involve lipid nanoparticle (LNP)-nucleic acid formulation, characterization, and optimization, as well as assisting in development of novel LNP characterization assays. Your nanoparticle expertise combined with Regeneron’s technology platforms, including viral and non-viral gene therapy, CRISPR-mediated gene editing, VelociGene transgenic mouse models, and the extensive catalog of fully human therapeutic antibodies, will be applied to make immediate contributions to the field of next-generation genetic medicine. As an Associate Scientist, a typical day may include the following: Performing, analyzing, and troubleshooting LNP characterization assays such as nucleic acid encapsulation efficiency (Ribogreen), sizing (DLS), surface properties (zeta potential), and...

Regeneron, located in Tarrytown, NY is seeking an energetic Process Development Engineer I to support technology transfer and business operations in the Technology Transfer & Logistics (TT&L) group within Preclinical Manufacturing and Process Development. In this role, you will lead production process transfer to support preclinical and clinical manufacturing at internal and external sites, as well as manage and coordinate a wide variety of departmental business operations. A Typical Day in This Role Might Look Like: Lead cross-functional teams to complete process transfer and establishment of production processes at internal and external clinical manufacturing facilities, with a focus on early-stage programs. Work to ensure the successful start-up of manufacturing production campaigns. Drive team cooperation to facilitate resolution of cross-functional issues and/or provide value-adding solutions. Ensure effective, accurate and timely communication...

Regeneron is currently looking for a Drug Product (DP) MSAT (Manufacturing Sciences and Technology) Engineer for our Device Assembly and Packaging team. This role will serve as combination device and secondary packaging design and development lead for biologic product packaging (clinical and commercial). Serve as a technical representative for CMO selection strategy, equipment qualification activities, and be hands on solving issues during technology transfer and cGMP start up. The MSAT team will strive to establish standard methodologies for technical support of cGMP manufacturing operations. As a DP MSAT Engineer, a typical day might include the following: Drives innovation in the area of device assembly, labelling and packaging by identifying the latest technological advancements and ensuring a creative environment and implementation aligning to business needs. Ensuring site to site consistency after the processes are optimally transferred, provide floor support during...

Regeneron's Preclinical Manufacturing & Process Development group (PMPD), located in Tarrytown NY, is seeking an energetic Process Development Engineer II as a full-time position to work in the Purification Development group. In this role, you will accelerate early-stage medicine development and scientific understanding, developing speed-to-clinic processes. This involves developing scalable downstream unit operations through bench and pilot scale experiments to transfer technical process knowledge for manufacturing. A Typical Day in the Role of Process Development Engineer II Might Look Like: Perform process development for clinical processes through bench scale and pilot scale experiments Document experiments, results, and findings in electronic laboratory notebook Maintain instruments and tackle instrumental/experimental problems Development or onboarding of new technology and automation to increase process throughput and efficiency of preclinical...

We are seeking a highly skilled and passionate Senior Scientist to support Regeneron Cell Medicine (RCM) mission to bring innovative cell therapy products to patients. This role will be critical to advance TCR- and CAR-based programs, as well as bring new ideas to improve our platforms and future programs. As a Senior Scientist, a typical day might include: Leveraging molecular biology techniques to design constructs, clone, and generate lentiviral vectors using proprietary platform technology Designing and carrying out experimental plans to functionally characterize TCR- and CAR-based T cell products through cell based assays and other relevant procedures to explore and validate novel cell therapy approaches. Maintaining detailed and timely records of experimental protocols, results, and observations. Identifying experimental challenges and collaborating with the team to troubleshoot technical issues and propose creative solutions to overcome obstacles....

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 Protein Expression Sciences - AAV team at Regeneron, located in Tarrytown, NY, is seeking an independent and highly motivated Sr Scientist to support the stable cell line development of viral vector technology. In this exciting role, yowill be conducting research activities around the design, characterization, and validation of engineered adeno-associated viruses  ​(AAV) components stable integration, to build a novel platform to Regeneron’s gene therapy technology. As a Sr Scientist, a Typical Day Might Include: Designing gene expression vectors. Performing molecular biology techniques (Cloning, Western blotting, DNA/RNA extractions, PCR, RT-PCR, quantitative PCR, etc.). Creating and validating stable integration cell lines.  Developing cell-based assays to analyze AAV vectors efficacy. Working collaboratively with team members, and with collaborators in various therapeutic focus areas and core facilities across research and discovery. Participating in team...