The role of the program manager is to manage cross functional teams responsible for delivering defined project outputs on time, within budget and importantly with quality results. Manager will need to plan, organize, monitor and oversee multiple projects to meet sometimes difficult to define requirements. The manager is able to react to change productively and handle othe

Assures that suppliers and raw materials are suitable for their intended use in the manufacture of clinical and commercial biologics bulk drug substance. Responsible for compliance with regulations, procedures, and systems that govern the supplier approval and material qualification programs. Supports client audits and regulatory inspections. Position Description SQM assi

The Microbiology Senior 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, development and execution of protocols and reports.

Manages the respective activities related to cGMP manufacturing, including the development and implementation of manufacturing methods, processes and operations for manufactured biopharmaceutical products. Ensures the effective use of material, equipment and personnel while producing products at high quality levels. Manages daily manpower requirements. Execute manufacturi

Responsible for coordination, modification, engineering and design of company facilities and equipment. Direct concurrent engineering projects both technical and project management aspects for capital projects while ensuring their success in meeting their respective objectives. Technical aspects include Architectural features, Structural/Civil, Biotech process and laborat

This individual will provide management and thought leadership expertise to the IT Validation and Compliance team that consists of direct reports at a senior and principle level as well as managed validation service resources in a Contract Development and Manufacturing Organization (CDMO) setting. Individual will ensure that adequate resources and processes are in place t

The Associate Director, Validation is accountable for validation activities at the KBI Boulder facility for the following disciplines Facilities qualification Utilities qualification Equipment qualification GAMP 3 5 automation qualification including Part 11 Cleaning validation including changeover equipment strategies Steaming validation Air visualization validation Prod

To support KBI's digital transformation, the Digital Product Owner III leads the creation and/or the expansion of one of our digital products which supports one or more of KBI's business units to sustain or improve the efficiency of the processes of that business or the company as a whole. This leadership role in our Digital Transformation journey bridges our company's pr

This position operates on a 2 2 3 schedule with 7 00 am to 7 00 pm shifts. The Manufacturing Assistant position is designed as an introduction to the industry of cGMP manufacturing. This position performs all routine/non routine cleanings and maintains gowning supplies for the locker rooms and gowning rooms at the CMF GMP facility to support continuous manufacturing opera

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

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

Quality Site Head at a contract manufacturer of mammalian cell culture protein therapeutics. Lead a Quality Assurance organization responsible for raw material inspection and release, QA on the floor, disposition of bulk drug substance, QA review of quality control data, and QA review of method validation, process validation, and equipment/utilities qualification. Quality

This position performs all dispensing and sampling of raw chemicals needed to support the manufacturing facility. This position requires a shift schedule and gowning into a clean room environment. This position requires PPE. Must be able to lift 50 pounds. Must be able to document, and record activities in electronic systems and comply with regulatory requirements, cGMPS,

The Microbiology Senior 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, development and execution of protocols and reports.

The Supervisor/Sr. Supervisor, Manufacturing, Floor Operations ( 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 and strict compliance wi