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 position operates on a 2 2 3 day shift schedule. The Manufacturing Technician position is designed as an introduction to the industry of cGMP manufacturing. This position performs all routine/non routine cleaning of equipment, prepares buffers/medias, glass wash of misc. parts, assembles setups and filters, autoclaves media/materials, tests filter integrity, manages

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

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 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 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 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

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

Perform contract testing services, including in process and release testing, method transfer activities, and qualification/validation activities for monoclonal antibodies, recombinant proteins, and peptides Position Responsibilities Performs testing on in process or drug substance/drug product and/or for method transfers/validations using bio analytical techniques such as

The Facilities Engineering Department is responsible for all aspects of maintaining the site infrastructure in an active reliable state to support cGMP operations. Facilities Engineering oversees the architectural features of the buildings, Structural/Civil, Biotech process and laboratory equipment and systems, HVAC, Plant and Clean Utility Systems, Electrical Power and L

Develop proposals in consultation with Sales, Project Management, and Analytical and Formulation Sciences Teams by assembling information, including project background, product design and specific technical information, tasks, objectives, outcomes, deliverables, methods, and budget. Review client RFPs, participate in client teleconferences, and discuss with supervisor to

KBI is seeking a laboratory operations specialist for the analytical formulations and sciences department. An ideal applicant should have strong communication skills, attention to details, curriculum history in the sciences, eagerness to collaborate and a passion for helping patients through medicines. Position Responsibilities At a granular level, in addition to other du

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

The Manufacturing Specialist I/II is responsible for supporting equipment and cGMP operations for the Upstream team in a large scale biopharmaceutical facility. The manufacturing specialist has experience in upstream unit operations (see expansion, bioreactor operations, cell culture harves), and a working knowledge of upstream equipment. The incumbent will have knowledge