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In-Process Support Associate at KBI Biopharma, Inc. responsible for performing cGMP in-process analytical support using bio-analytical techniques such as HPLC and UV-Vis. Duties include data analysis, documentation upkeep, and maintaining chemical handling protocols.
Reviews data associated with testing of in-process and drug substance/drug product samples and development, transfer, qualification, and validation of analytical methods.
The QA Specialist I/II Manufacturing is responsible for assuring products, processes, facilities, documentation, and systems conform to quality standards and regulations. Key responsibilities include compliance review, authoring procedures, supporting manufacturing changeover, and resolving deviations.
The Program Manager is responsible for client account and relationship management, program management, and business/financial management. They lead cross-functional teams, manage project timelines, and support the Program Management Organization.
The Principal EM Systems Administrator provides technical leadership and administrative management for KBI's MODA EM system. Responsibilities include system design, development, support, maintenance, and training delivery. Requires 7+ years of experience with software implementation in a cGMP environment and proficiency in IT or QA roles.
The S&OP Master Planner II role at KBI involves leading global planning and execution of key planning nodes, focusing on Supply Planning. Responsibilities include collaborating with various teams, modeling supply risks, working with procurement and vendors, and contributing to the Global S&OP process. The role requires a BS in Science or Engineering with 4 years of industry experience or equivalent.
Responsible for executing experimental protocols and performing data analysis in biopharmaceutical laboratories. Conducts testing on samples using bio-analytical techniques, maintains knowledge of instrumentation, and adheres to safety procedures. Requires Bachelor's degree in chemistry, biochemistry, or related area with 2+ years of experience.
Responsible for executing experimental protocols and performing elementary data analysis in biopharmaceutical development laboratories. Conduct troubleshooting analysis and maintain knowledge of instrumentation. Maintain proper chemical handling and safety procedures. Bachelor's/Master's degree in chemistry, biochemistry or related area required with 0+ years' experience.
Supervise and coordinate analytical activities in support of commercial manufacturing, release, and stability. Manage project deliverables, ensure compliance with cGMP, and provide technical support for product testing. Lead and develop team members, maintain documentation, and recommend staffing needs. Requires 2+ years of experience and knowledge of cGMPs and biotechnology regulations.
The PAT MS&T Manager is responsible for establishing and directing department level activities, resources, and business processes for tech transfer, process engineering, process validation, and pilot lab operations at the CMF site. Responsibilities include overseeing commercial product introduction, establishing procedures and strategies for successful production, managing resources, and leading staff meetings.
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