Please Note: This is a night shift opportunity and is eligible for a shift differential on top of the posted range. This position is on a 2-2-3 shift. Night Shift(7pm-7am). The Manufacturing Associate I/II. (Manufacturing Associate). is responsible for performing upstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Manufacturing Associate must follow written, approved procedures and forms to en...
Position Summary. The Manufacturing Quality Assurance (MQA) Specialist is responsible for supporting the Manufacturing Process and Areas as part of a rapidly expanding GMP Contract Manufacturing Organization. MQA Specialists are expected to provide sound guidance to Manufacturing with respect to process, SISPQ of product, and risk. MQA Specialists share responsibility for the inspection readiness of the site. MQA Specialists routinely work on the...
Job Summary. The Downstream Process Development (PD) Scientist I provides process development input and co-ownership for a product, including all development and design decisions, with oversight and mentorship from senior process development staff. They can apply scientific principles to design and execute laboratory studies for unit operation development and optimization. They possess a developing working knowledge of the downstream functional a...
Plan, schedule, and support daily production tasks to ensure schedule adherence while maintaining a successful and GMP compliant execution. Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T and PD, QA, Maintenance and Engineering, and AFS and Microbiology. Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orde...
Position Summary. Responsible for supporting the Facilities Engineering (FE) Department as part of a rapidly expanding GMP Contract Manufacturing Organization. Facilities Engineers have FE responsibility for the entire area they serve. They are expected to be the Subject Matter Expert (SME) in their respective areas. These areas include all systems throughout the site. Facilities Engineers are responsible for ensuring the site is well maintained ...
The candidate should be able to apply engineering principles in-order to problem-solve and drive projects to successful completion within defined timelines. The ability to manage multiple projects and resources is required. The candidate should have the ability to work independently with minimal direction and have excellent communication skills. The scope of this role includes. Lead technical transfer projects for new molecules as well as platfor...
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary. KBI is implementing an electronic laboratory notebook (ELN) system at our Durham, NC site location. A site-specific ELN Admin, report...
Position Summary. This individual supports all QA activities related to Facility Engineering and Validation in a contract manufacturing organization (CMO) setting. Execute QA review and approval of documentation to result in timely oversight of equipment, computer systems, utilities, and facilities to support start-up of a new commercial manufacturing programs and subsequent routine operations. This individual provides quality oversight of facili...
Please Note: This is a night shift opportunity and is eligible for a shift differential on top of the posted range. This position is on a 2-2-3 shift. Night Shift(6pm-6am). JOB SUMMARY. The Senior Manufacturing Associate I/II. (Sr. Manufacturing Associate). is responsible for performing downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Sr. Manufacturing Associate must follow written, appro...
Job Summary. This is a night shift position (7p-7a) with a 2-2-3 rotation. The Supervisor, Manufacturing, Floor Operations 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 with safety and quality regulatio...
Job Summary. This is a night shift position (7p-7a) with a 2-2-3 rotation. The Supervisor, Manufacturing, Floor Operations 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 with safety and quality regulatio...
The. Lead Manufacturing Associate. is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. This position is for a 2,2,3 pitman day shift schedule starting at 6:00 AM to 6:30 PM. The Lead Manufacturing Associate must follow written, approved procedures and forms to ensure all work is conducted “Right First Time” (RFT) following Good Manufacturing Practice (GM...
