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 investigations. environmental permit management. and risk management. Implements all ap...
Job summary. The Sr. Director, Manufacturing oversees the management of all areas of the Manufacturing department, including the upstream processing (cell culture and harvest), downstream processing (purification and bulk filling), and manufacturing support teams. The overall aim is to produce bulk intermediates and/or bulk drug substances while achieving quality, schedule, and cost objectives. Responsibilities include. Oversees hiring, training,...
COMPANY: KBI Biopharma, Inc. LOCATION: 1101 Hamlin Road, Durham, NC 27704 TITLE: Director, Facilities DUTIES: Manage the Maintenance, Metrology, and Facilities functions for all KBI Biopharma North Carolina Sites. Direct corrective and preventative maintenance and repair of facilities, utilities, and equipment. Support large Capital Expense Projects on the design, construction, start-up, and commissioning of Facilities and Facilities related equi...
Position Summary. 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 documentation for laboratories, mechanical spaces, and administ...
Position Summary: 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 assists with processing client projects for material qualific...
Job Summary: To support KBI's digital transformation, KBI Biopharma is looking for a passionate Digital Product Owner to lead the creation of one of our digital products which supports the MS&T and Manufacturing departments. The purpose of the product is to improve the efficiency of business processes and data access, analysis and visualization. This role would join the small and dynamic “Digital Product and Advanced Analytics” group within the 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 Assurance organization is also responsible for internal auditing, supplier ...
Position Summary. The Facilities Engineering Intern will interact with a diverse group of people in support of the Facilities Engineering Department. The Facilities Engineering Intern will participate in the technical aspects of capital project implementation to ensuring the project's success in meeting its respective objectives. Technical aspects may include. Develop, evaluate, and design specifications and contract drawings. Perform a variety o...
Position Summary. This position will provide validation support for at least one of the following areas. Facilities qualification. Utilities qualification. Equipment qualification. Manufacturing process control system qualification. Cleaning validation. Computer system validation. The incumbent will support data retrieval, compilation, verification, and comparative analysis from a variety of paper and electronic system formats. This will include ...
Seeking a highly motivated and detail-oriented intern to assist with data cleanup in our Salesforce instance. This internship opportunity will provide valuable experience in data management and contribute significantly to the enhancement of our overall operational efficiency. Term. May 20th - August 9th. 2024. Responsibilities. The intern will be responsible for. Identifying and merging duplicate accounts. Completing and updating account informat...
Position Summary 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 Lighting, and Automation for the cGMP facility. As an essent...
Position Summary. Perform the day-to-day management and distribution of a rapidly growing library of biologics samples. Will be responsible for checking in, registering, and aliquoting new samples, maintaining database and Access/Excel inventories, and labeling and distributing outgoing samples. Will work closely with basic automation (i.e. Tube Cappers, barcode readers, automated liquid handlers) to streamline high-throughput workflows. Position...
