16 jobs found in Wichita, KS

At Regeneron, our medical affairs physicians and scientists are at the forefront of innovation, playing a crucial role in our global development organization. As a key liaison between Regeneron and the scientific and healthcare community, you will be part of an optimally aligned matrix structure delivering therapeutic and functional area expertise in our Oncology division. You will engage in scientific exchange and collaborate with therapeutic area experts on disease and product information as well as research initiatives. You will present scientific data, clinical data, and disease state awareness in response to requests for information to diverse audiences (therapeutic area experts, practitioners, investigators, research coordinators, site personnel and internal stakeholders). A typical day might include: Identifying and maintaining a list of relevant medical/therapeutic area experts, investigator targets, and associated plans of action. Responding to requests for...

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 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....

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 Upstream Sciences, Downstream Sciences, Analytical Technologies, IPC lifecycle, Data Analytics, Manufacturing Support, Process Validation and Process Solutions. As a Supervisor within Process Sciences a typical day might include, but is not limited to, the following: Coordinating, organizing and assigning the daily/short term activities of operations and supporting employees executing against established guidelines and common procedures & policies Coordinating the provision of technical support to the manufacturing process Coaching, mentoring and developing staff, including overseeing new employee onboarding and providing career development planning and opportunities to direct reports Communicating business and organizational information/priorities and...

Within this role you will be responsible to specialize in developing new QC microbiology test methods; providing critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. This position may be actively involved in Alternative and Rapid Technologies associated with Microbiological Assays. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods. This is a 12-month temporary contract As a QC Micro Specialist, a typical day might include, but is not limited to, the following: Identifying, introducing, onboarding and initially qualifying alternative and rapid technologies applicable to microbiological assays and procedures, becoming the SMEs of these technologies, assays, and procedures Leading Test Method validations, studies and assisting in troubleshooting efforts (Investigations). These include test methods transferred or developed...

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 Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out.  The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.  This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly.  Contributes and drives ongoing process improvement initiatives.  This role has a 3-day onsite minimum requirement in our Dublin office. This role is NOT eligible for fully remote. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as...

Within this role you will be part of the QC Technical Resources Material Identification Team and will be responsible for identifying unknown material observed at IOPS.  As a Senior QC Scientist a typical day might include, but is not limited to, the following:   Executing investigation testing (FT-IR, SEM, ICP-MS, SEM, GC) for the chemical identification of unknown material for manufacturing, process sciences or quality control support Evaluating/interpreting data, author and review technical documents for investigational testing Establishing, developing and/or optimizing analytical methodology for the analysis of unknown compounds/contaminates/debris in varying matrices Participating in routine maintenance and troubleshooting of laboratory instrumentation Liaising with contract laboratories as required to support investigational analysis Tabulating results and writing summary reports of assay development and validation studies Presenting findings at group...

As a QC Staff Scientist in Biochemistry you would participate in assay development, transfer, and validation for QC. You would provide technical support, guidance and supervision for release, stability, and in-process testing and assay development/validation and/or transfer. In this role a typical day might include, but is not limited to, the following: Participating in assay development/validation for QC Reviewing and approving new test procedures and assays Evaluating new methodologies, techniques and equipment when new procedures are warranted Participating in transfer of methodology from R&D Generating and/or supporting completion of compliance records, CAPAs, change controls and deviation notifications as needed Evaluating assay performance through yearly method performance reports Facilitating assay transfer from R&D and to business partners Providing technical input into additional studies supporting regulatory filing e.g.. Bridging/comparability...

SUMMARY: We are seeking a Senior Manager of Global Patient Safety who will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Ophthalmology Therapeutic Area. This includes safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment. As a Senior Manager of Global Patient Safety a typical day might include the following: Perform signal evaluation for identified signals and author the safety evaluation reports and Health Hazard Reports Run the preparation and review of aggregate safety documents including DSUR, PSUR, RMP, IB, responses to health authority queries and queries from other departments Prepare and deliver presentations at Signal Management Team (SMT) meetings Participate in clinical study team meetings for assigned compounds. Owning the day-to-day operations and directly to the efficient functioning of the Safety Sciences team...

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. Within this department, the Upstream Process Sciences team perform laboratory scale mammalian cell culture studies in support of manufacturing operations. As a Process Scientist in the Upstream group a typical day might include, but is not limited to, the following:   Performing scientific investigations related to upstream unit operations of biologics manufacturing processes at laboratory scale Using Design of Experiments (DOE) or other experimental principles to develop experimental protocols Assisting in root cause analysis of process related deviations using scientific data–driven rationale Contributing to knowledge-based reports summarizing conclusion of studies, investigations and process improvements Presenting findings at group meetings Producing and...

As a QC Analyst you will perform a wide variety of analytical chemistry testing to support in-process and bulk drug substance manufacture in a cGMP regulatory environment. . T he successful candidate will be required to work shift which includes days & nights. A typical day might include, but is not limited to, the following:   Gathering data and documenting test results Reviewing test results to ensure compliance with standards; reports any quality anomalies Complying with all pertinent regulatory agency requirements Participating in required training activities Maintaining laboratory supplies Conducting testing on raw materials, in-process, product, stability, and/or research samples Writing and revising control test procedures and SOPs Completing test records and reviewing data Calibrating or verifying calibration of instruments/devices prior to use Interacting with outside customers or functional peer groups Owning the...

Within this role you will perform testing to ensure cGMP compliance in the manufacturing facility.  Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.   Note, this is a shift based role (12/7 - extended days) As a QC Micro Analyst a typical day might include, but is not limited to, the following: Entering a laboratory cleanroom’s to collect and log samples for microbial analysis Performing bioburden and endotoxin sample analysis in accordance with standard operating procedures (SOPs) Performing sample analysis for microbial identification Performing environmental monitoring including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas Performing acceptance testing of commercially prepared microbiological culture media. Autoclaving microbiological media and laboratory waste as needed Ensuring that all work...

As a QC Analyst you will perform a variety of chemical or biological analyses on raw materials, products, in-process materials, or stability samples in support of the company’s quality program. T he successful candidate will be required to work shift which includes days & nights. A typical day might include, but is not limited to, the following:   Gathering data and documents test results Reviewing test results to ensure compliance with standards; reports any quality anomalies Complying with all pertinent regulatory agency requirements Participating in required training activities Maintaining laboratory supplies Conducting tests on raw materials, in-process, product, stability, and/or research samples Writing and revising control test procedures and SOPs Completing test records and reviewing data Calibrating or verifying calibration of instruments/devices prior to use Interacting with outside customers or functional peer groups...

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 Project Specialist within Process Sciences a typical day might include, but is not limited to, the following:   Serving as a primary contact for the cross-functional activities with Manufacturing, QC and external partners involving Process Sciences Identifying areas of operational improvements to reduce errors and increase organizational / operational efficiency Handling and analyzing large amounts of unstructured information and distill into easy-to-understand presentations and other documents Involving the appropriate subject matter experts (SMEs) to answer detailed...

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, hypercholesterolemia, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, allergic asthma, oncology, and atopic dermatitis. This internship is designed to be both educational and practical. In this position, the intern will learn how to take skills they may have acquired in college related to Biomedical / Life Science and apply them in a professional setting. They will gain a better understanding of the role that Clinical Trial Management plays in the business and be better prepared to work in the arena of Clinical Trial Management The Student will: Learn and support...