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Job Locations US-TX-College Station
Posted Date 59 minutes ago(4/22/2021 3:39 PM)
Summary: The QC Chemist – Raw Materials I, under direct supervision, will be responsible for assisting with raw material sampling, managing quarantine materials and prepare sample shipments for contract laboratory testing. They will also assist with supporting the Quality Control department in the release of all raw materials from the Quarantine Cage/Area for use in Non-GMP and GMP manufacturing activities for NCTM and TBF-100.   Other responsibilities may include but are not limited to: Filing folders, Managing SAP for material accountability at TBF-100 and at NCTM, ordering materials for sampling, coordinating with Materials Management/Warehouse Department on release of components and chemicals, and acquiring BSE/TSE, OAF, USP Class VI statements and/or applicable documents from vendors.
Requisition ID
2021-14886
Job Locations US-TX-College Station
Posted Date 3 days ago(4/19/2021 5:46 PM)
Summary The Cell Biology Analyst I, under general direction, will be responsible for performing routine and non-routine quantitative and qualitative analysis of samples submitted to the Quality Control (QC) Laboratory.
Requisition ID
2021-14876
Job Locations US-TX-College Station
Posted Date 3 days ago(4/19/2021 5:42 PM)
Summary The Cell Biology Analyst II will be responsible for participating in the Technology Transfer of established methods into the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory. 
Requisition ID
2021-14875
Job Locations US-TX-College Station
Posted Date 7 days ago(4/15/2021 5:32 PM)
Summary:  The Quality Control Compliance Manager leads the tracking, coordination, and closure of Quality Control’s CAPAs, change controls and deviations.  The successful candidate will also assist the QC department in OOS/OOT investigations.  The candidate will ensure all PRs and change controls are closed out in a timely manner.   
Requisition ID
2021-14862
Job Locations US-TX-College Station
Posted Date 7 days ago(4/15/2021 5:16 PM)
Summary: The Quality Control Stability Coordinator will be responsible for carrying out supporting activities on the stability program according to current regulations.  This includes working with Clients to draft stability protocols, physically setting up stability studies according to respective stability protocols (staging), updating and maintaining stability planning/scheduling tools, ensuring timely execution of stability pulls at each time point, ensuring timely execution of in-house or external testing, writing summary reports, and ensuring the timely delivery of customer-oriented data and documentation.
Requisition ID
2021-14861
Job Locations US-NC-Research Triangle Park
Posted Date 1 week ago(4/14/2021 3:31 PM)
Support the Quality Assurance (QA) Informatics program by using Visual Basic to develop and support data metrics trackers and KPI templates in various software platforms.
Requisition ID
2021-14855
Job Locations US-NC-Morrisville
Posted Date 3 days ago(4/19/2021 11:59 AM)
We are searching for a motivated and hardworking IT professional with Infrastructure knowledge with broad technical knowledge of enterprise classes covering, networking, Security, web technologies, distributed computing and cloud, SAN technologies, database and middleware technologies. This candidate should have experience designing, planning for and deploying application hosting and core data center infrastructure in support of large scale, custom developed applications. Successful candidates will create logical infrastructure designs for complex projects that span the multiple infrastructure technologies.
Requisition ID
2021-14853
Job Locations US-NC-Research Triangle Park
Posted Date 5 decades ago(12/31/1969 7:00 PM)
We are searching for a self-motivated individual to perform general to advanced facility and utility repairs/cosmetic improvements to plant facilities. The Facility Mechanic I will perform routine mechanical troubleshooting and preventive maintenance (PM) tasks.
Requisition ID
2021-14852
Job Locations US-NC-Morrisville
Posted Date 3 days ago(4/19/2021 11:51 AM)
The Staff Validation Engineer is a high-level position in the Validation department of FDBU.  This position will directly report to the Associate Director of Manufacturing Technology and Support, but may also have a functional reporting relationship to a senior colleague on a project to project basis.
Requisition ID
2021-14846
Job Locations US-NC-Morrisville
Posted Date 5 decades ago(12/31/1969 7:00 PM)
The Quality Control Planning Intern position assists the Quality Control Planning Manager with the administration of planning activities within the Quality Control Laboratory. This position will provide support with the general administration of the SQC system including template creation, product test mapping, forecasting administration, and additional projects as required by the lab leadership team. This position coordinates with QC Managers, Supervisors, and Analysts to ensure laboratory readiness to support all incoming testing and may additionally support other laboratory planning activities as required.
Requisition ID
2021-14842
Job Locations US-TX-College Station
Posted Date 2 weeks ago(4/9/2021 11:37 AM)
Summary:  The Manufacturing Readiness Coordinator assists the Manufacturing team to ensure right-first-time execution on the GMP manufacturing floor and on time starts by coordinating and delivering readiness milestones. 
Requisition ID
2021-14808
Job Locations US-NC-Research Triangle Park
Posted Date 2 weeks ago(4/8/2021 9:11 AM)
The Facilities Engineer will be responsible for assisting with trouble-shooting facility and utility systems on an as needed basis which includes but not limited to chillers, air handler units (AHUs), WFI loops, clean steam generators, boilers, air compressors, process waste, etc. Provide investigation, engineering and change control support for all systems including investigation of deviations of facility and utility systems and the determination of the root cause, along with the development of corrective actions to prevent reoccurrence. In addition to the basic qualifications listed below, he/she shall possess the skills required to successfully develop and execute project tasks and deliverables, be a collaborative team player, handle 2-3 small projects at a time, establish and manage priorities, and have a strong drive to deliver quality projects. Required engineering capabilities include the ability to develop and implement engineering and design concepts for HVAC, Plant Steam / Condensate, and process utilities. The candidate shall also have a thorough understanding of the development of design documents and deliverables through the conceptual, preliminary, detailed, and construction phases of a project (P&lDs, distribution plans, specifications, etc.).
Requisition ID
2021-14789
Job Locations US-NC-Morrisville
Posted Date 2 weeks ago(4/8/2021 2:53 PM)
The Analytical Method Transfer (AMT) group in our Morrisville, NC location is seeking a dynamic Senior Scientist to manage the team-based execution of assay protocol driven activities for client programs.  The AMT group is a technologically diverse group that primarily performs formal Tech Transfer, Qualification, Validation and Verification of test methods coming out of the development group and then transitions them into our Quality Control group. This high performing group is the interface between the development and quality groups and is responsible for ensuring long term success of the methods entering into QC.
Requisition ID
2021-14783
Job Locations US-NC-Morrisville
Posted Date 2 weeks ago(4/8/2021 2:53 PM)
The Analytical Method Transfer group is seeking a Scientist I with protein chemistry experience. The AMT group is a technologically diverse group that primarily performs formal Tech Transfer, Qualification, Validation and Verification of test methods coming out of the development group and then transitions them into our Quality Control group. This high performing group is the interface between the development and quality groups and is responsible for ensuring long term success of the methods entering into QC.
Requisition ID
2021-14782
Job Locations US-NC-Morrisville
Posted Date 2 weeks ago(4/8/2021 2:53 PM)
The Analytical Method Transfer group is seeking an Associate Scientist with protein chemistry experience. The AMT group is a technologically diverse group that primarily performs formal Tech Transfer, Qualification, Validation and Verification of test methods coming out of the development group and then transitions them into our Quality Control group. This high performing group is the interface between the development and quality groups and is responsible for ensuring long term success of the methods entering into QC.
Requisition ID
2021-14781
Job Locations US-TX-College Station
Posted Date 2 weeks ago(4/6/2021 9:15 AM)
Summary This position requires working 2nd shift. The Manufacturing Supervisor may be assigned to work directly with Upstream, Downstream or Buffer Preparation Unit Operations.  This individual will supervise a team of employees directly or indirectly in these production process units.
Requisition ID
2021-14776
Job Locations US-NC-Morrisville
Posted Date 2 weeks ago(4/8/2021 2:54 PM)
The Master Scheduler is responsible for the maintenance of the Production Plan in the ERP system to support the MRP (Material Requirement Planning) process. Responsible for providing the Supply Chain team with a monthly production plan consistent with the asset / production plan and forecasted demands. New business opportunities, customer expectations, internal supply requests, and internal supply constraints will be used to load the production plan in ERP system for a defined period. Strong collaboration with Operations and Supply will be critical to meeting the business objectives.
Requisition ID
2021-14771
Job Locations US-TX-College Station
Posted Date 3 weeks ago(4/3/2021 12:12 PM)
Summary:  This position requires working 2nd shift. Under limited supervision of the Sr. Manager, Materials Management, the Materials Specialist II is responsible for the accurate receipt, verification, record keeping, distribution, and shipment of materials and goods.
Requisition ID
2021-14769
Job Locations US-TX-College Station
Posted Date 3 weeks ago(4/3/2021 12:12 PM)
Summary: This position requires working 2nd shift. The Materials Management Specialist is responsible for drafting and implementing supply chain management procedures governing the receiving, warehousing, ordering, shipping and internal distribution of cGMP (current Good Manufacturing Practices) and non-GMP materials.
Requisition ID
2021-14768
Job Locations US-TX-College Station
Posted Date 3 weeks ago(4/3/2021 12:12 PM)
Summary: This positon requires working 2nd shift.   The Manufacturing Technician IV will work directly with a range of technologies. The Technician IV level provides an opportunity to stay on the technical track, or work towards a supervisory path. Dependent upon assignment, the range of technologies may include any of the following: - Upstream Unit: - Single-Use Cell Culture Vessels/Bioreactors up to 2000L - Bacterial Fermentation Culture Vessels up to 2000L - Alpha Wasserman Continuous Flow Centrifuges - Disposable Magnetic Mixing Bags and Totes - Cell Expansion and Propagation - Banking/Cryopreservation of Cell Lines and Viruses - Hyperstack, Cellstack, and other Adherent Cell Technologies - Plate counting, microscopic examination - Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation - Downstream Unit: - Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF), Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration - Medium to Large-scale Chromatographic systems (ÄKTA). - Pre-Packed Columns from 1L to 100L - Single use mixing systems (Pall & GE) - Single Use connectivity types such as GE DAC and Colder AseptiQuik - Bulk filling - Aseptic process simulation and drug product filling - Plate counting, microscopic examination - Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation - Buffer Preparation Unit: - Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs - Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs - Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures - Integrity testing of filters
Requisition ID
2021-14767