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

This position operates on a 2 2 3 schedule with the hours of 7 00 am 7 30 pm. The Manufacturing Associate I/II (Manufacturing Associate) is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Manufacturing Associate must follow written, approved procedures and forms to ensure al

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

The Upstream MS&T Engineer III will apply sound scientific and engineering principles to successfully transfer and enroll new biopharmaceutical processes into the cGMP manufacturing facility. The scope of this role includes Leading technical transfer projects for challenging mid late stage clinical manufacturing programs and commercial programs Driving business decisions

Responsible for executing experimental protocols andperforming 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

Candidate must have strong mechanical aptitude to support maintenance of specialized production equipment, plant utilities, and HVAC systems in accordance with established guidelines and Standard Operating Procedures. Perform general facility support activities including safety system inspections, personnel relocation, and general site maintenance and repair as required.

This individual will provide QA oversight of the Deviations, CAPA and Complaints organization. The Sr. Manager and works closely with the Program Management team to facilitate communications between KBI and clients regarding quality related events. The role will develop and maintain the Quality Assurance staff by recruiting, training, and managing team member. Position Re

This Quality position collaborates with Manufacturing, MS&T, Facilities Engineering, Supply Chain, and IT to ensure completion of Root Cause Analysis, CAPAs and Effectiveness Checks (ECs) for Deviations according to cGMP requirements and the company's SOP. The role is directly responsible for review and approval of Deviations, CAPAs and ECs and provides the support for ti

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