Search the 21 jobs at KBI Biopharma

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.

Implement and lead environmental, health, safety, and sustainability (EHS&S) program at biologic contract development and manufacturing organization. Responsibilities include incident response, environmental permit management, and risk management. Coordinate with operations to mitigate risks and ensure compliance with EHS&S programs. Conduct audits, inspections, and investigations. Develop and revise EHS&S procedures to promote safety and compliance. Minimum requirements include Bachelor's degree in occupational health and safety field and 3-8 years of industry experience or Bachelor's degree in technical discipline and 5-10 years of experience as a safety professional. Preferred experience in cGMP manufacturing environment.

Provide QA oversight of the Deviations, CAPA, and Complaints organization. Develop and maintain the Quality Assurance staff. Track, trend, compile, and report quality metrics. Support Client Audits and Regulatory Inspections. Partner with Program Management and other departments. Communicate with clients regarding quality-related events.

Senior Quality Assurance Specialist responsible for collaborating with various departments to ensure completion of Root Cause Analysis, CAPAs, and Effectiveness Checks for Deviations according to cGMP requirements. Write Deviation investigations, provide metrics to management, mentor QA staff, and participate in cross-functional teams to improve the Deviation/CAPA system. Review and approve Deviations and CAPAs in support of GMP manufacturing operations.

The Program Manager is responsible for managing cross-functional teams to deliver defined project outputs on time, within budget, and with quality results. This role involves client management, program management, business/financial management, and PMO support. The manager must react to change productively and handle various assigned tasks effectively.

The Senior Manager, Global Supply Chain Planning at KBI Biopharma is responsible for overseeing material planning and execution, maintaining an accurate supply of materials, optimizing cash flow, and leading a team of planners. They also establish and mature CPFR processes, ensure MRP parameters are maintained, support SAP implementation, identify supply risks, and draft contingency plans.

Conduct financial analysis to support business decisions, assist with month-end close process, perform account reconciliations, generate reports on billing activities, and support implementation of new ERP systems. Requires minimum of 3-5 years of experience in Billing, Accounts Receivable, and analysis with knowledge of accounting principles and proficiency in Microsoft Excel and financial modeling.

A Process Development Associate in the Process Operations team responsible for driving robustness and consistency in the laboratory, executing laboratory studies, authoring operational documents, and participating in process development meetings. Basic understanding of Process Development methods/unit operations and scientific principles required.

The PD Associate Scientist provides process development input for a product, executes laboratory studies, authors technical documents, supports technology transfer activities, and ensures compliance with safety procedures and regulatory requirements.

Scientist II position at KBI Boulder Analytical Development team in AFS, responsible for performing analytical testing, developing and supporting testing for GMP activities. Duties include troubleshooting bio-analytical techniques, authoring GMP data and reports, providing technical support, and improving processes. Requires continuous improvement mindset and generation of high-quality data/documentation.

Responsible for supporting the FP&A department by providing leadership and coordination of financial planning activities, analyzing key business drivers, and preparing financial reports and projections. The role involves collaborating with the leadership team, managing data consolidation for forecasts and budgets, and handling ad-hoc requests from stakeholders.