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This individual will support Supply Chain and management of internal materials movement under cGMP compliance. Main responsibilities will include material handling, receiving, inventory control, and supply of cGMP materials for Manufacturing and Quality Control. Developing and onboarding an ERP to provide cGMP compliance in inventory control and supply. Material Handling responsibilities will inc
Posted Today
Job Summary The successful candidate will apply scientific and engineering principles to support new biopharmaceutical process enrollments into the cGMP manufacturing facility. Job Description • Collaborate with process development and manufacturing teams to perform technical transfer and facility fit activities for downstream processes. • Perform all aspects of facility fit activities t
Posted 4 days ago
Perform laboratory support functions such as sample log in and storage, stability scheduling, log in and storage, issuance of controlled data forms, and monitoring of temperature controlled chambers in compliance with standard operating procedures, safety, and cGMP regulations . Responsible for all associated documentation and for maintenance of stability/sample coordination areas. Job Description
Posted 4 days ago
Responsible for owning and performing raw material quality disposition for the Colorado site. This position will provide a broad range of quality oversight for the warehouse and raw materials program. This position will be responsible for review and approval of procedures and methods supporting all aspects of GMP operations, including support of client and regulatory audits. Owns and performs raw
Posted 5 days ago
Performs microbiological in process and release testing in support of GMP manufacturing. Tests include, but are not limited to, bioburden, microbial purity and endotoxin. Execute environmental monitoring within all classified manufacturing areas according to approved SOP’s and cGMP’s Review EM data for completeness and accurate, and assist with data trending. Provide EM support for m
Posted 7 days ago
Job Description Performs microbiological in process and release testing in support of GMP manufacturing. Tests include, but are not limited to, bioburden, microbial purity and endotoxin. Execute environmental monitoring within all classified manufacturing areas according to approved SOP’s and cGMP’s. Review EM data for completeness and accurate, and assist with data trending. Provide
Posted 8 days ago
This position supports all KBI Boulder Health, Safety and Environmental (HSE) programs and requires a working knowledge of OSHA and EPA regulations. Interface with staff in all work areas to support a positive, practical, safe and compliant work environment. Interface with management and system owners or area managers to provide status reports, plan program activities and review HSE program effec
Posted 11 days ago
Responsible for executing experimental protocols and performing elementary data analysis in biopharmaceutical development laboratories. Job Description Regularly exercises technical discretion in the execution and interpretation of experiments that contribute to project goals. Makes detailed observations and carries out elementary data analysis. Understands experiments and conducts troubleshootin
Posted 11 days ago
ReSPONSIBILITIES The ideal candidate will have Operational Excellence / Lean Six Sigma expertise and ideally manufacturing, process development and/or new technology introduction experience. The incumbent will support and manage key continuous improvement initiatives and high value cross functional projects. Incumbent will actively manage several projects concurrently. Specific job responsibiliti
Posted 11 days ago
Receives, stores, and distributes materials, tools, equipment, and products within establishment by performing the following duties Maintain shelf life and lot controls for Boulder Stockroom, keeping accurate inventory levels and performing year end physical counts. Dispense GMP raw materials and components for use manufacturing using SOP’s, solution prep documentation and batch records. R
Posted 12 days ago
This role has daily supervisory responsibility for a team of Materials Handlers. The team responsibilities may include materials receipt, dispensing, kitting, shipping warehousing and distribution of supplies. This role is responsible for building weekly work schedule aligned with production demands, partnering with Materials Planning and QA to ensure materials are received and release to meet pro
Posted 12 days ago
Responsibilities You will manage cGMP system for incoming samples. Receive and log in samples as per SOP. Maintain inventory and chain of custody. This position performs QC laboratory support functions such as sample log in and storage, stability scheduling, log in and storage and monitoring of temperature controlled chambers in compliance with standard operating procedures, safety, and cGMP regul
Posted 12 days ago
Responsible for the development of analytical test methods used for testing samples from the upstream and downstream development organization and performing elementary data analysis. Responsible for the development and execution of method qualification protocols of developed analytical test methods. Regularly exercises technical discretion in the execution and interpretation of experiments that co
Posted 14 days ago
Job Summary Build and foster relationships with new and existing clients in the assigned sales region to grow sales for KBI Biopharma. Identifies, evaluates and develops strategic biopharmaceutical business opportunities to provide KBI services for clients developing and commercializing biopharmaceutical drugs. Establishes and implements appropriate development strategies to support business objec
Posted 16 days ago
Position Description KBI’s Particle Characterization Core is looking for a scientist or engineer to become our next colleague and learn the fine art of particle characterization. Our new associate will have an active role in a dynamic laboratory environment that will include learning cutting edge analytical techniques, development of data analysis tools, establishing direct relationships wit
Posted 19 days ago
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