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Manages all activities related to operation daily support regarding ERP system utilization as well as all Master data for all GMP activities Job Responsibilities Analyze manufacturing spending, monthly, track invoices and guarantee proper classification of expenses. This includes proper classification by department as well as understanding and requesting reclassification of expenses to clients. Ex
Posted 1 day ago
The Cell Culture (Upstream) Supervisor is a key position for a talented and capable team player with competent and proven cell culture fundamentals. The incumbent will lead manufacturing floor operations to ensure ‘Right the First time’ execution of early and late phase Cell Culture programs safeguarding work environments and enforcing cGMP compliant operations. Job Description Upstrea
Posted 2 days ago
The incumbent will be responsible for project management of key manufacturing operations continuous improvement initiatives and high value cross functional projects. The incumbent will have experience with project management and lean six sigma methodology ideally in operations, process development and/or new technology introduction. Incumbent will actively manage several projects concurrently. Key
Posted 3 days ago
Develop, implement and manage comprehensive, integrated learning and technical training in order to maximize employee productivity at a new commercial mammalian cell culture manufacturing facility. During site build out, work with subject matter experts (SMEs) to enhance and expand training program at nearby sister site for adoption and implementation at new site. Upon start up of new site, drive
Posted 6 days ago
Job Summary Responsible for a wide variety of cell related functions, including producing cells, intermediate product, and manufacturing final product for commercial distribution. Follow SOPs, perform daily tasks in a clean room, retain records and write reports . May also be responsible for troubleshooting. Job Description Assist in execution of procedures for cell culture manufacturing, purific
Posted 6 days ago
Job Summary Coordinate and perform cGMP manufacturing operations for manufactured biopharmaceutical products. Ensure the effective use of material, equipment and personnel while making products at high quality levels. Job Description Assist in execution of procedures for cell culture manufacturing, purification, or support area of manufacturing using SOP's and batch records. Use equipment a
Posted 6 days ago
Job Summary Responsible for a wide variety of cell related functions, including producing cells, intermediate product, and manufacturing final product for commercial distribution. Follow SOPs, perform daily tasks in a clean room, retain records and write reports . May also be responsible for troubleshooting. Job Description Assist in execution of procedures for cell culture manufacturing, purific
Posted 6 days ago
The role holder will oversee the management of manufacturing operations (upstream cell culture and downstream protein purification) and related support teams (media/buffer prep, equipment stewardship, batch record writing, improvement projects) involved in producing drug substances in a Mammalian Cell Culture Manufacturing facility. In addition, he/she will lead manufacturing readiness activities
Posted 6 days ago
Responsible for executing experimental protocols and performing 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 conducts troubleshooting analysis.
Posted 9 days ago
Job Summary KBI Biopharma, Inc. is a contract services organization committed to reducing process development time, decreasing production cost and increasing speed of development for biopharmaceuticals. We are seeking an In Process Support Associate with strong protein chemistry background to perform cGMP in process analytical support. These services include in process and release testing for dru
Posted 9 days ago
We are currently seeking an Analytical Development Coordinator to coordinate complex timeline and deliverable schedules for Analytical Development in a biotechnology manufacturing environment across cross functional teams within the department. The Analytical Development Coordinator will be responsible for the following Develops and manages Analytical Development timelines to ensure project delive
Posted 9 days ago
This position is responsible for the compliance review of Biopharmaceutical Development GMP data. This includes the review and approval of release, in process, and stability test data. This position is also responsible for the review and approval of method qualifications and validations. Another responsibility is the review and approval of laboratory investigations and deviations associated with t
Posted 9 days ago
Job Summary Responsible for quality computer system administration, providing technical/end user support for quality computer system, and maintaining close communication with management to keep stakeholders apprised of quality computer system incidents/ resolutions, project validation status, and other relevant issues. The role requires leading and/or assisting in quality computer system validatio
Posted 9 days ago
Job Summary Join a highly technical analytical team in a dynamic work environment. Participate in contracted client analytical programs as a member of Analytical, Formulation and Stability (AFS). With a focus on plate based assays (ELISA and qPCR), abilities in other analytical techniques applicable to the business needs are desirable (HPLC, UPLC, western blot, SDS PAGE, CE SDS, etc). Job Descript
Posted 9 days ago
Responsible for executing experimental protocols and performing 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 conducts troubleshootin
Posted 9 days ago
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