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 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

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 Maintenance and Facilities Manager is responsible for ensuring buildings, equipment and systems are maintained and fit for use. The Manager oversees day to day maintenance and calibration operations including planning and scheduling, coordination of work order execution, troubleshooting and problem solving, and ensuring quality and completeness of all associated docum

Assist with drafting, and revision of manufacturing batch records, procedures, and supporting records. Support new equipment enrollment qualification activities. Assist SMEs with laboratory equipment supporting manufacturing operations troubleshooting, vendor calls, equipment repair coordination, operational changes, and system qualifications. Support safety initiatives,

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.

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 is accountable for managing assigned inventories through daily, weekly, monthly, and annual physical counts. The Inventory Analyst organizes and partners in conducting periodic inventory counts, adjusts quantities and locations, records and reports discrepancies to management while maintaining communication with supported internal customers. Will be the lead

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

The specialist has responsibility for the implementation of the environmental, health, safety, and sustainability (EHS&S) program. This includes leadership to maintain EHS&S compliance and continuous improvement. EHS&S supports operations of biologic contract development and manufacturing organization. Responsibilities include incident response, reporting and investigatio

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

Assist with and support execution of routine procedures within the manufacturing area. Position Responsibilities Order and stock general supplies in the manufacturing production areas Wash glassware/labware and clean equipment Perform GMP cleaning of suites as required Maintain records to comply with regulatory requirements, cGMPs, and SOPs The responsibilities of this po

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