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Provide on the floor compliance support as a Quality Assurance representative during critical manufacturing operations. Review of executed batch records and logbooks. Conduct QA walkthroughs, room clearance activities (including changeover), and participate in safety walkthroughs. Assist the Manufacturing Operations staff with assessment, initiation, notification, and closure of deviations from es
Posted Today
Responsible for Health, Safety and Environmental aspects of company staff and facilities at the new Commercial Manufacturing Facility. Responsibilities Interface With KBI Commercial Manufacturing Facility Staff High visibility in all work spaces to support a positive, practical, safe and compliant work environment. Interface with Management Communicate regularly with system owners or area managers
Posted Today
Able to manage a small team within Program Management, ensures project and business management is executed appropriately within the team. With personal responsibility for a portfolio, the role holder is the primary client account and relationship manager for KBI PMO, driving business delivery and exemplary client service to maximum benefit for the company in a sustainable manner. The incumbent may
Posted Today
Responsible for developing analytical methods for large molecules; developed methods are used to support upstream and downstream development efforts and for GMP release and stability testing Job Description Executes experiments for developing analytical test methods for use in process development support and ultimately cGMP testing. Understands experiments, conducts troubleshooting analyses, an
Posted Today
The Engineer III/ Sr. Engineer will apply sound scientific and engineering principles to successfully transfer and enroll new biopharmaceutical processes into the cGMP manufacturing facility. The scope of this role includes Leading technical transfer projects for off platform and late stage clinical programs Driving business decisions and operations related to facility fit, time in plant and new t
Posted Today
General responsibility for the installation, 24/7, day to day operation, maintenance, and modification of all KBI Biopharma site systems. This position is also responsible for repairs, troubleshooting, corrective (repair/unplanned/modification) and preventative (planned) maintenance of associated systems and equipment. The technician must be able to work both independently and as a team member. Co
Posted Today
This individual will provide QA oversight for analytical and microbial laboratory activities to support of the start up of a new commercial biopharmaceutical manufacturing facility as well as subsequent routine cGMP manufacturing operations. Job Responsibilities Supervises team responsible for review and QA disposition of in process and finished bulk drug substance test data. Manages daily activit
Posted Today
Provides experienced technical and operational support at all levels for the computer systems of KBI Biopharma, Inc. Perform maintenance and upkeep tasks on servers, network hardware, and workstations. Plans and implements improvement projects to make IT systems and business processes more efficient, reduce downtime and improve the end user experience. JOB RESPONSIBILITIES Provide desktop and end
Posted Today
The successful candidate will apply scientific and engineering principles to support new biopharmaceutical process enrollments into the cGMP manufacturing facility. Job Description Collaborate with process development and manufacturing teams to perform technical transfer and facility fit activities for downstream processes. Perform all aspects of facility fit activities to support program enrollme
Posted Today
This role will be responsible for identifying and managing all Continuous Improvement(CI) initiatives at KBI Biopharma in Boulder CO. Through the disciplined use of measurements, observation, analysis, and discussion of alternatives, the Director will facilitate the development of best practices which improve the Quality, Delivery and Cost of KBI manufactured products. The Director plans, manages
Posted Today
Provide on the floor compliance support as a Quality Assurance representative during critical manufacturing operations. Review of executed batch records and logbooks. Conduct QA walkthroughs, room clearance activities (including changeover), and participate in safety walkthroughs. Assist the Manufacturing Operations staff with assessment, initiation, notification, and closure of deviations from es
Posted Today
The Manufacturing Compliance Specialist supports the rapidly expanding GMP Contract Manufacturing Operation. The Specialist will need to produce high quality documentation that contributes to the overall success of our operations. Independently responsible for the efficient and thorough investigation of process deviations (that occur in manufacturing; Upstream, Downstream and/or Support), determin
Posted 1 day ago
The Manufacturing Training Specialist is a member of the manufacturing group for a Contract Development & Manufacturing Organization (CDMO) performing research, process development and GMP manufacture of mammalian cell culture bulk drug substance. The core responsibility of the Manufacturing Training Specialist is to coordinate all aspects of the training program for the GMP manufacturing team
Posted 1 day ago
There are two positions open for this role, one in Boulder CO and one in Durham NC Quality Site Head at a contract manufacturer of microbial fermentation 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 v
Posted 1 day ago
This individual will be responsible for review and QA disposition of data for in process and finished bulk drug substance intended for cGMP use. Provides QA oversight of analytical and microbial laboratory activities including but not limited to method qualification, method transfers, creation and revision of test methods, specifications, stability studies and laboratory deviations. The QA Analyti
Posted 1 day ago
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