16 jobs found in Wichita, KS

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...

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....

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...

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...

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...

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...

Within this role you will be responsible for operational, maintenance and troubleshooting support for utilities, facilities, HVAC & building systems through strict adherence to Standard Operating Procedures (SOPs) and cGMP's. As a Maintenance Technician (Utilities) a typical day might include, but is not limited to, the following: Performing daily operations, maintenance and repairs on utilities, WFI, clean steam, bulk gases, bulk chemicals, process water generation, boilers, chillers, chemical dosing systems, cooling towers, air compressors, LPHW skids, waste water treatment, biowaste inactivation skids or other mechanical equipment in a cGMP environment with minimal supervision Monitoring and interpreting readings on equipment, computer terminals/HMIs, switches, valves, gauges, alarms, safety devices and meters to detect leaks or malfunctions ensuring that equipment is operating efficiently and safely Identifying any off-nominal conditions with mechanical...

Within this role will manage the day-based support requirements of the manufacturing operations team while providing direction, troubleshooting and guidance while maintaining safety compliance and audit readiness and ensuring objectives are delivered to a high standard and on time. As an Associate Manager Biotech Production (Downstream Operations) a typical day may include, but is not limited to, the following. Ensuring that all documentation (SOPs, Manufacturing Records, Batch Sheets & Logbooks) is current, accurate, reviewed and in accordance with regulatory requirements Leading, motivating, and managing the operation manufacturing specialist teams Preparing reports by collecting, analysing, and summarizing information and trends Tracking of relevant metrics to ensure operations are performing effectively and efficiently Implementing a contamination free program to ensure highest process success rates Working to the highest safety standards and supports...

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...

Within this role you will be responsible for providing support, direction and subject matter expertise on equipment reliability issues to Facilities Production, Utilities and HVAC teams. You will be evaluating current plant equipment for reliability and assesses alternative options available. The role involves maintaining data of current equipment performance to identify and prevent potential reliability issues & implement reliability monitoring programs to provide maximum uptime of equipment. As a Senior Reliability Engineer a typical day might include, but is not limited to, the following:   Leading reliability improvements to identify opportunities in advance to support planned and predictive replacement versus reactive replacement using existing and developing technologies Providing support, direction and subject matter expertise on mechanical reliability issues Producing and implementing the site reliability policies for all equipment and...

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...

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...

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...

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...