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Search Results Page 1 of 7

Job Locations US-TX-College Station
Posted Date 5 hours ago(4/3/2020 5:33 PM)
Summary: The QC Coordinator will construct, maintain, and oversee the Quality Control Testing Schedule to include release testing, stability testing, and method qualification activities.  The Quality Control Coordinator, under general direction, will be responsible for implementing a Quality Control Master Schedule to guide QC activities supporting batch release and stability testing.  The position will also require frequent communication with the Analytical Development and Assay Method Transfer groups to coordinate and schedule method qualification activities.  The Coordinator will assist the QC Analyst’s and QC Management to navigate GMP documents through the EDMS system.  Close attention to detail is required to update the Master Schedule on a daily basis to ensure QC deadlines and milestones are met.  Other responsibilities may include but are not limited to: Compiling data for Batch Disposition.  Attending planning meetings as needed.  Communicating gaps and schedule changes to QC Area Managers.  
Requisition ID
2020-12965
Job Locations US-NC-Durham
Posted Date 7 hours ago(4/3/2020 3:43 PM)
The QC Manager will be responsible for managing Analytical and Biochemistry testing within the cGMP Quality Control labs.  The manager will be responsible to manage a team of analysts and scientists focused on the analysis of stat, release and stability testing of biotechnology products.  The manager will have accountability for exceptions associated with test execution (deviations, CAPAs, OOS, OOT) and be expected to manage each to their timely closure in partnership with technical product leads, the clients and Quality Assurance. 
Requisition ID
2020-12961
Job Locations US-NC-Morrisville
Posted Date 2 days ago(4/1/2020 3:32 PM)
The Scientist II independently designs, executes and interprets complex laboratory experiments and development activities with priorities set by supervisor to achieve project goals. The individual demonstrates a practical understanding of own scientific discipline and applies knowledge in support of product development and new technologies.
Requisition ID
2020-12947
Job Locations US-TX-College Station
Posted Date 2 days ago(4/1/2020 3:21 PM)
Summary: The Quality Assurance (QA) Analyst III, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally.
Requisition ID
2020-12946
Job Locations US-TX-College Station
Posted Date 2 days ago(4/1/2020 3:00 PM)
Summary: The Quality Assurance (QA) Specialist for Data Integrity will be responsible for the day to day running of the FDBT Data Integrity Program, performing data integrity assessments, gap confirmation and risk assessments, generate Remediation Plan, and categorize gaps based on business priority and risks.
Requisition ID
2020-12945
Job Locations US-TX-College Station
Posted Date 2 days ago(4/1/2020 2:51 PM)
Summary:The Maintenance Planner/Scheduler under the supervision of the Manager, Maintenance Operations is responsible for the planning, scheduling and performance of the maintenance program including the oversight of the Computerized Calibration & Maintenance Management System (CCMS/CMMS) in support of multiple manufacturing facilities such as the National Center for Therapeutic Manufacturing (NCTM), the Texas Biological Facility (TBF) and the Flexible Biological Facility (FBF) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT).Primary responsibilities include managing the daily maintenance operations such as screening of incoming work orders, identification of job requirements, procurement of equipment and specialized tools, scheduling of maintenance staff, parts inventory control and monitoring of maintenance tasks performance. This position will interact with other maintenance and technical trades, such as manufacturing operators, engineers, calibrations technicians, validation, quality and external suppliers in order to provide a high level of excellence over the maintenance operational activities of FDBT.
Requisition ID
2020-12944
Job Locations US-NC-Morrisville
Posted Date 3 days ago(3/31/2020 12:12 PM)
The Commercial Development Manager will identify, manage the initial qualification, and close through the signing of a letter of agreement for new business. This position will support the West Coast, U.S.A.  
Requisition ID
2020-12936
Job Locations US-NC-Morrisville
Posted Date 3 days ago(3/31/2020 12:04 PM)
The Process Engineer 1 is an entry-level position in the Manufacturing Technology Support (MT&S) department at FDBU.  This position will report directly to the Director, MT&S, but may also have a functional reporting relationship to a senior colleague on a project to project basis.   They work independently and with colleagues to provide assistance for the design, development, standardization and maintenance of an operational biotechnology utilized in the manufacture of proteins and drug substances. This person would become familiar with a variety of core manufacturing and operational technologies including equipment used in: Fermentation, Cell Culture/Single Use Technology, Filtration, Centrifugation and Chromatography, Mixing and Buffer Preparation, Parts washing and Sterilization, and Homogenization
Requisition ID
2020-12935
Job Locations US-NC-Morrisville
Posted Date 1 week ago(3/27/2020 3:38 PM)
The Vice President of PD provides strong leadership to the major process development departments, fostering an environment where innovation and efficiency can both thrive, setting annual goals and objectives and long range planning.  The VP, PD creates high-level business strategy for the, oversees the management of resources and coordinates activities across multiple departments to achieve business objective and revenue goals.  They will serve as the strategic leader for the site and advocates for the process development and Innovation departments with upper management and external parties.
Requisition ID
2020-12927
Job Locations US-NC-Morrisville
Posted Date 1 week ago(3/24/2020 11:34 AM)
The Senior Director of Human Resources is responsible for planning, developing, implementing and directing policies and programs encompassing all aspects of human resources, including strategic planning, organizational design, employment, compensation and benefits, employee relations, equal employment opportunity, performance management, employment law, compliance and human resource information systems management.  They are responsible for driving and supporting a positive culture by sponsoring teams that focus on employee engagement programs, efforts and activities for the site.  Responsible for the oversight of the FDBU Training Department. Responsible to the COO for the effective and efficient utilization of manpower for the Company.
Requisition ID
2020-12900
Job Locations US-TX-College Station
Posted Date 2 weeks ago(3/19/2020 5:37 PM)
Summary: The Quality Assurance (QA) Specialist Supplier quality will be responsible for supporting the supplier quality program.  The Specialist will assist with ensuring all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility.
Requisition ID
2020-12893
Job Locations US-TX-College Station
Posted Date 2 weeks ago(3/19/2020 5:29 PM)
Summary: The Quality Assurance (QA) Specialist of compliance, will be responsible for supporting performance of the Quality Systems group.  The Specialist will assist with the tracking and coordination and closure of Deviations, Events, Change Controls, and CAPAs.
Requisition ID
2020-12892
Job Locations US-TX-College Station
Posted Date 2 weeks ago(3/19/2020 10:55 AM)
Summary: The Quality Control Cell Biology Lead, with limited supervision, will be responsible for overseeing day to day operations of the QC Cell Biology Group.  This position will involve handing out daily assignments, ensuring assignments are completed within the given time period, and reviewing data.  The Quality Control Cell Biology Lead will also participate in Project Team Meetings.  The successful candidate will assist in Method Qualifications, Technology Transfer of established methods, and performing in-process, release and stability testing as needed. 
Requisition ID
2020-12886
Job Locations US-NC-Morrisville
Posted Date 3 weeks ago(3/11/2020 4:18 PM)
The Quality Assurance group at Fujifilm Diosynth Biotechnologies is seeking a highly motivated individual to join us as a QA Technical Specialist in our Contract Manufacturing site located in Research Triangle Park, NC. The ideal candidate will be a subject matter expert for Quality Assurance systems and compliance activities.
Requisition ID
2020-12860
Job Locations US-TX-College Station
Posted Date 4 weeks ago(3/9/2020 9:29 AM)
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
2020-12840
Job Locations US-CA-San Diego | US-CA-San Francisco | US-WA-Seattle
Posted Date 4 weeks ago(3/9/2020 9:23 AM)
Requisition ID
2020-12839
Job Locations US-TX-College Station
Posted Date 4 weeks ago(3/9/2020 9:23 AM)
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
2020-12838
Job Locations US-TX-College Station
Posted Date 1 month ago(3/6/2020 3:26 PM)
Summary:  The Maintenance Technician I, under the supervision of the Facilities Maintenance Supervisor, or designated supervisor will be responsible for performing various aspects of utilities, facilities and process equipment maintenance and support for the Texas Biological Facility (TBF), the Flexible Biological Facility (FBF) and the National Center for Therapeutic Manufacturing (NCTM) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT). Primary responsibilities include various aspects of maintenance and support for facilities, utility equipment and biotech processing equipment. This position will be required to use technical manuals, on-line resources and OEM representatives to maintain the equipment operational with a minimum of downtime. Strict adherence to Standard Operating Procedures (SOPs), cGMPs and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory. This position is for a night shift position after an appropriate training period with more technical staff.
Requisition ID
2020-12836
Job Locations US-TX-College Station
Posted Date 1 month ago(3/6/2020 3:24 PM)
Summary:  The Maintenance Technician II, under the supervision of the Facilities Maintenance Supervisor, or designated supervisor will be responsible for performing various aspects of utilities, facilities and process equipment maintenance and support for the Texas Biological Facility (TBF), the Flexible Biological Facility (FBF) and the National Center for Therapeutic Manufacturing (NCTM) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT).   Primary responsibilities include various aspects of maintenance and support for facilities, utility equipment and biotech processing equipment.   This position will be required to use technical manuals, on-line resources and OEM representatives to maintain the equipment operational with a minimum of downtime. Strict adherence to Standard Operating Procedures (SOPs), cGMPs and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory.   This position is for a night shift position after an appropriate training period.
Requisition ID
2020-12835
Job Locations US-NC-Morrisville
Posted Date 1 month ago(3/5/2020 3:07 PM)
Requisition ID
2020-12829