Summary: The Associate Principal Scientist – Analytical Method Transfer (AMT) focuses on the qualification and validation of Analytical Methods used at FUJIFILM Diosynth Biotechnologies (FDB). The AMT group is a protocol-driven group that primarily perform Tech Transfer, Qualification, and Validation of test methods coming out of the FDB analytical groups and transition them into our Quality Control group. The Associate Principal Scientist position will predominately focus on managing a group in AMT to create analytical method protocols and summary reports, executing protocols, reviewing data, ensuring a seamless transition to the QC group in a manner that sets them up for “right first time” and prolonged execution success, troubleshooting issues/spearheading investigations and working closely with the QA group and client. The individual will typically lead customer projects and as expected to complete technical assignments through the self-sufficient design, execution, and interpretation of complex experiments.

Summary:  The Manufacturing Planner leads  the creation and maintenance of the short-term production outlook schedule per S&OP Asset Plan and given operational parameters in manufacuring. The primary ouput of this position is the Master Production Schedule and the Monthly Supply KPI metrics report for FDBT.  The Planner reviews prodcution schedules  for opportunities and adjustments based on inputs from Manufacturing readiness, supply chain and program management.  Clear concise updates on the schedule changes are required, and are tailored to the audience (internal customers such as program managers, Finance, Maintenance, Quality and  Manufacturing). The Manufacturing Planner will gather information from various sources (Manufacturing, Program Management, Tech Ops, Supply Chain) for the creation of schedule templates, active production schedules, trackers, and planning tools to support FDBT Manufacturing.  The Manufacturing Planner should have proven ability to review, interpret and capture information from the Asset Plan, Process Specifications, Process Consumable Lists and SAP BOM (or similar resources) needed for planning and to create schedules for specific production centers, projects or functional areas as needed.  The Manufacturing Planner should have the ability to transfer the current planning system over to the SAP system and share knowledge and experience of SAP planning with coworkers.  The Planner will develop and maintain consistent verbal and written communication flows with internal customers and stakeholders to ensure that planning timelines and criteria are conveyed and understood in a timely manner.  The Manufacturing Planner will lead planning projects and planning meetings.

Summary:  The Manager, Manufacturing Compliance Coordination (FBF) is responsible for all manufacturing CAPAs, change controls and deviations. This includes the leading of all manufacturing deviation investigations through to completion, support of all internal and external audits and collaboration with cross functional groups including Quality Assurance to support ‘on-time’ release and disposition of batches and other post-execution activities.

Summary:  The Quality Assurance Environmental Monitoring Specialist will be responsible for supporting the EM program, review and approval of EM investigations, proactive trend identification of EM trends, supporting the conceptualization / implementation / and effectiveness checks of corrective or preventative actions as it pertains to the sites EM program.

Summary: The Quality Assurance Compliance Specialist III - QA Validation, will be responsible for the review and approval of commissioning/qualification/validation protocols, reports, computer automation validation protocols and final reports and discrepancies for Quality Assurance. The QA Compliance Specialist III – QA Validation, will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.

Summary:  The Manufacturing Process Engineer I – is an entry-level position in the manufacturing   department in support of the drug product life cycle located at the Texas Bio Manufacturing Facility in College Station, Texas.  This position will report directly to the Sr. Manager DP Manufacturing but may also have a functional reporting relationship to a senior colleague on a project to project basis.   Works independently, and with colleagues, to provide expertise and assistance for the design, development, standardization and maintenance of an operational filler machines utilized in the aseptic fill for drug product.  This person would become the subject matter expert on core manufacturing and operational technologies for the manufacturing unit.  Operational biotechnologies include:  Isolators and their use in the single use technology, visual inspection and work under aseptic and clean rooms. This position will also require to aseptically gown, create training programs and perform training for manufacturing technicians in the “shop floor” in the unit operation categories.

Summary:  The Biotechnology Process Sciences Technician I functions within a team based organization to actively address cGMP manufacturing requirements.  The individual’s main responsibility is to obtain documentation for cGMP appropriate materials (raw materials and components), prepare item specifications for these materials and track the completion of the specification paperwork.  The individual will also assist with other cGMP pre-production activities such as the selection of cGMP appropriate materials and equipment as directed.   This individual must work in a collaborative manner to assist the transfer of biological drug processes from process development (internal or client) groups in a CDMO environment.

Summary:  The Quality Assurance (QA) - Compliance Specialist I for Audit & Inspection will be responsible for  supporting all associated audit responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance, including supporting client audits, regulatory inspections, and conducting internal and supplier audits.

Summary: The Quality Assurance – Sr. Compliance Specialist – Audit and Inspection, will support all associated audit responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.

Summary: The Microbiology Analyst III will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.

Summary: The Microbiology Analyst II will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory. 

Summary: The Microbiology Analyst I will be responsible for assisting the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory. 

Summary: The Microbiology Lead will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.

Summary:  Our Automation team in College Station, Texas is expanding and we are looking for Automation Technicians to provide technical and operational support, execution of projects and improvements, installation, operation, maintenance and troubleshooting of FUJIFILM Diosynth Biotechnologies Texas, LLC automation systems to meet organizational goals and objectives. This position will also work closely with other operators, technicians and engineers to maintain complex systems.

Summary: The CAPEX Project Coordinator, under the supervision of the Associate Director of Project Engineering and Capital Projects, will be responsible for the support of capital projects documentation through the management of initiation and close out documents, schedule tracking, and multi-departmental approval routing. 

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 Change Control records.

Summary:  The Drug Product Operations Technician I will work directly with the Vanrx SA25 Vial Filling Isolator,. following aseptic techniques and procedures in a cGMP environment. 

Summary:  The Senior Automation Engineer - Operations provides technical support and accountability for the execution of operational activities that are critical to the success of our business. This position will also work closely with other departments to maintain automated systems and related quality requirements.

Summary:  The Associate Scientist – Analytical Method Transfer (AMT) will function collaboratively and productively in a team devoted to ensuring the quality of effective analytical methods at FDBT. The individual should possess experience with several bioanalytical techniques that are used to assess viruses and proteins as well as strong technical writing skills.   The AMT group is a protocol-driven group which will primarily perform Tech Transfer, Qualification, and Validation of test methods coming out of the FDB analytical groups and transition them into our Quality Control group. The position will primarily focus on executing analytical method protocols, summarizing data, coordinating instrumentation needs, finalizing test methods and ensuring a seamless transition to the QC group in a manner that sets them up for “right first time” and prolonged execution success. The candidate will be expected to follow cGMP documentation practices.  

Summary:  The Assistant Scientist – Analytical Method Transfer (AMT) will function collaboratively and productively in a team devoted to ensuring the quality of effective analytical methods at FDBT. This is an entry-level position that will require training on laboratory instrumentation and appropriate documentation of results to support customer programs.   The AMT group primarily performs Tech Transfer, Qualification, and Validation of test methods coming out of the FDB analytical groups and transitions them into our Quality Control department. The position will mostly focus on learning a subset of analytical techniques and following the procedures outlined in approved protocols, then analyzing and summarizing data. The individual will also be responsible for supporting the group with tasks such as ordering supplies, equipment maintenance, coordinating sample shipments, and preparing buffers. The candidate will be expected to follow cGMP documentation practices.