Provide calibration, troubleshooting and repair of analytical instruments. Provide calibration, troubleshooting and repair of development instruments used in upstream process development, downstream process development, and analytical development laboratories. Perform and/or coordinate scheduled preventive maintenance on HPLC's, UPLCs, capillary electrophoresis instru

Responsible for contributing to the development, maintenance, and continuous improvement of the GMP Training Program. Facilitate projects and training initiatives that drive quality, compliance, and operational effectiveness for the organization. Develop training materials and provide guidance in development and implementation of a consistent training program. Assess new

The incumbent will have Operation Excellence / Lean Six Sigma expertise and ideally manufacturing, process development and/or new technology introduction experience. The incumbent will support and manage key Manufacturing continuous improvement initiatives and high value cross functional projects. Incumbent will actively manage several projects concurrently. Job Responsib

Effectively leads a team within Program Management or large Project Management function, ensures appropriate development and control of related processes and systems. With personal responsibility for a portfolio, the role holder is the primary client account and relationship manager for KBI PMO, driving business delivery and exemplary client service to maximum benefit for

Oversees the management of all areas of Upstream manufacturing (media preparation, cell culture and harvest steps) and related Specialist support teams involved in producing drug substances with the aim of achieving schedule, quality and cost objectives. Job RESPONSIBILITIES Lead Upstream staff hiring, oversee training and lead staff evaluations. Develop an engaged and hi

KBI Leuven is working on many different projects and is searching for a QA/QP Specialist to join their ambitious small sized team located in Leuven, Belgium. Responsibilities Under the direction of the Head QA Leuven site, the QA/QP Specialist will be responsible for Performing the Qualified Person (QP) function as regards Batch certification, as defined by Directive 2001/

This Manufacturing Sciences and Technology (MS&T) Principal Engineer position will lead a team responsible for process development, and process transfer for clinical and commercial manufacturing. This person and their team will also have responsibilities for the ownership of processing equipment and unit operations, including system design, procurement, installation, and

The Microbiology Associate will be part of the Microbiology Department responsible for the testing and support for the Microbiology Laboratory in support of a Contract Manufacturing biotechnology facility and Process Development. Responsibilities includes laboratory support, program testing, reporting of results, execution of protocols. This person is responsible for the

This position is on a 2 2 3 shift, 7a 7p. The Manufacturing Associate I/II Downstream is responsible for the execution of production activities for early and late phase Cell Culture programs within a GMP environment. The Manufacturing Associate I/II Downstream must follow the instructions depicted in SR's, EPR's, BR's, SOP's and forms. Additionally, must ensure all work i

This position represents an opportunity to apply engineering expertise at the Engineer II level in the Manufacturing Sciences and Technology group in support of GMP production operations at the Boulder, Colorado manufacturing facility. Position Responsibilities Qualified candidates would have the ability to provide biological engineering principles to the process developm

This position is on 2 2 3 shifts, 7a 7p. The Sr. Manufacturing Associate I/II MFG Support is responsible for the execution of production activities of Media and Buffer preparation within a GMP environment. The Sr. Manufacturing Associate I/II Support must follow the instructions depicted in SR's (Media / Buffer Solution Records), SOP's and forms. Additionally, must ensure

This position is on 2 2 3 shifts, 7p 7a. The Sr. Manufacturing Associate I/II MFG Support is responsible for the execution of production activities of Media and Buffer preparation within a GMP environment. The Sr. Manufacturing Associate I/II Support must follow the instructions depicted in SR's (Media / Buffer Solution Records), SOP's and forms. Additionally, must ensure

To provide Metrology support and services to KBI's internal operations. Shift Schedule Monday Friday 8 30 am 5 30 pm Position Responsibilities Perform scheduled calibrations on equipment and systems in the facility, which include Manufacturing, Analytical Labs, Utilities, and Warehouse. Manage and maintain instrument calibration documentation and CMMS database. Responsibl

This position operates on a 2 2 3 schedule, with 7 00 pm 7 00 am shifts. The Manufacturing Supervisor leads a team of manufacturing associates to perform upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Supervisor will plan, assign, and monitor daily tasks to ensure timely "Right First Time" execution

Perform the day to day management and distribution of a rapidly growing library of biologics samples. Will be responsible for checking in, registering, and aliquoting new samples, maintaining database and Access/Excel inventories, and labeling and distributing outgoing samples. Will work closely with basic automation (i.e. Tube Cappers, barcode readers, automated liquid h