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The Sr. Manager of MES Operations will lead and manage technical guidance for the IT manufacturing systems team. Responsibilities include executing digital strategy for MES solutions, adhering to GMP regulations, managing resources, ensuring compliance with system lifecycle processes, and addressing issues effectively while communicating across all levels of management.
The Supervisor/Sr. Supervisor in Manufacturing leads teams in upstream and downstream processing of biopharmaceutical products, ensuring compliance with safety and quality standards. Responsibilities include planning and monitoring production tasks, reviewing batch documentation, training staff, and driving continuous process improvements.
The Process Development Associate I supports laboratory studies, executes lab work, documents and reports results, and authors operational documents. The role requires a basic understanding of Process Development methods, technical writing skills, and the ability to perform experiments from instructions. Responsibilities include evaluating new technologies, maintaining training compliance, and participating in process development meetings.
The MS&T Document Specialist at KBI will manage the creation and revision of batch records, bill of materials, and oversight of change controls within a quality system, ensuring efficient manufacturing processes.
The S&OP Master Planner II leads global planning and execution, focusing on Supply Planning and validating purchase requisitions. Responsibilities include collaborating with cross-functional teams, modeling supply risks, reviewing purchase requisitions, and contributing to demand and capacity planning efforts.
The EHS&S Specialist III is responsible for implementing environmental, health, safety, and sustainability programs, ensuring compliance, and continuous improvement. Duties include incident response, permit management, risk management, and conducting audits and inspections. The specialist collaborates with KBI staff and management, communicates program activities, and represents KBI during regulatory inspections.
The Research Associate I/II/SRA will execute experimental protocols, perform elementary data analysis, and troubleshoot in biopharmaceutical development laboratories while maintaining detailed records and safety protocols.
The QA Compliance Auditor will manage the internal audit program for the KBI CMF in Durham, overseeing audits, evaluations of compliance with regulations, and reporting findings. The role includes driving a culture of compliance, supporting quality assurance processes, and leading initiatives to improve operational efficiency in a regulated environment.
The Research Associate I/II supports testing for biopharmaceutical manufacturing, conducts laboratory experiments including electrophoresis and HPLC, performs data analysis, and ensures compliance with safety procedures. They maintain knowledge of scientific literature and assist in instrumentation upkeep.
The Research Analyst I/II positions involve supporting in-process testing, conducting laboratory experiments, analyzing data, and maintaining safety protocols within biopharmaceutical development. Analysts are responsible for running tests like electrophoresis and HPLC, managing experiment documentation, and keeping up-to-date with scientific literature.
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