Summary:Fujifilm Diosynth Biotechnologies, Texas, Inc. is offering exciting summer internships for college students who have completed at least their sophomore year. We provide a...

Summary:  The Process Sciences - Associate Scientist/Engineer, under general direction, functions within a team based organization to actively address cGMP manufacturing issues.  The individual is responsible for analyzing process technologies to assist in the technical transfer of new processes into the manufacturing group.   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 Process Sciences – Assistant Engineer, under general direction, functions within a team based organization to actively address cGMP manufacturing issues.  The individual is responsible for analyzing process technologies to assist in the technical transfer of new processes into the manufacturing group.   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.

A Sr Process Engineer 1 provides engineering technical guidance with limited or no direction, primarily focusing on client process fit within existing facility designs and specifying equipment and facility gaps for Drug Substance (DS) and Drug Product (DP) processes. This role champions transformation of engineering, manufacturing, and facility technologies, participates in industry forums, and provides technical engineering expertise for new processing equipment designs, installations and modifications to existing equipment and facility.

Summary:  The Manufacturing Readiness Coordinator II 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.

The Logistics Coordinator provides end-to-end coordination and execution of all Operations activities associated with the arrangement, disposition, shipment, and delivery of materials in Warehouse custody to authorized clients. Responsibilities in this role include for storage, handling, and distribution of materials and products and working closely with multiple areas to support operations (e.g., Manufacturing, Quality, Process Sciences, and other customers) as needed. The Logistics Coordinator provides interdepartmental communication daily, and liaisons with couriers, clients, vendors and Broker. This role uses SAP ERP system for inventory management, cycle counting, and shipping activities...

The Manufacturing Technician III will work directly with a range of technologies. Dependent upon assignment, the range of technologies exposed to will be:

This position is both hands-on and strategic, requiring knowledge of financial principles, negotiation, and relationship management. The candidate will review sales proposals, business contracts, analyze financial implications, and contribute to the profitability modeling process. They will collaborate extensively with internal teams, supporting decision-making with financial insights. The incumbent will be the subject matter expert for contract review and understand the importance of revenue recognition. In this role, you will understand legal contracts and clauses and be able to determine the cost impact for a CDMO facility.

The Quality Assurance (QA) Analyst I, under direct supervision, will be responsible for assisting with the review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting with product related activities; Assisting with Quality audit functions; Identifying process and Quality System improvements.   Reports to     ...

As a System Manager, ServiceNow you will be part of Global ERP & Enterprise Services team within the FDB IT Department. You will work together with other highly dedicated and skilled colleagues focused on the mission of ensuring a stable, efficient, and compliant IT services. Simplicity and agility...

The Sr. Specialist 1, QC LIMS supports the Laboratory Information Management system (LIMS) in accordance with appropriate regulatory, corporate, and scientific guidelines. The Sr. Specialist 1, QC LIMS configures, validates and provides ongoing maintenance within the LIMS platform. This role is expected to complete and review change requests, validate configurations, provide user support and troubleshoot as needed. This role is responsible for implementing approved configuration changes within the LIMS platform as outlined in controlled change management records. The role supports documentation revisions in accordance with governing SOPs to ensure the system and procedures operate in a state...

The Technician 1, Maintenance is responsible for assisting installation, maintenance, and repair of process related systems/equipment. Ensure these systems meet the stringent requirements of pharmaceutical manufacturing. Also responsible for conducting regular inspections and preventive maintenance on process related equipment to ensure equipment is operating efficiently with minimal downtime.

Summary:  The Associate Director (AD) Quality Operations is responsible for QA oversight of cGMP operations and areas at one of the manufacturing facilities, or the Quality Control unit, at FDBT.  This role is expected to lead a value stream such as TBF, FBF, NCTM or Analytical Development under the guidance of the Sr Director Quality Operations, lead the Quality Operations organization to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external stakeholders.  Direct all QA on-the-floor,...

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

The Senior Accounting role at FDB is a critical position that oversees the company’s accounting functions, ensuring compliance with generally accepted accounting principles, company policies and financial management practices specific to the contract manufacturing industry. This role demands exceptional organizational abilities, a strong technical accounting background and outstanding communication skills. The successful candidate will effectively manage multiple projects and assignments with competing deadlines.

The Engineer or Scientist 2 for Process Validation helps ensure that manufacturing processes meet the validation and regulatory requirements for the process to be reproducible under normal operating conditions. This role contributes to the design, execution, and documentation of process validation protocols for equipment, systems, and manufacturing processes. Additionally, this role works with cross-functional teams to help ensure processes are consistently producing high-quality products in a safe and efficient manner.

The Manufacturing Technician I works directly with a range of technologies. Dependent upon assignment, the range of technologies may include any of the following:

The QA Engineer, Pharmaceutical Quality Systems (PQS) Audits & Inspections is responsible for the day-to-day activities of the Pharmaceutical Quality Systems (PQS) team. This role is primarily responsible for coordinating GMP customer audits and regulatory inspections and supporting the Quality Management Review on a local and global level.

The Associate Director (AD), Program Quality is responsible for building and sustaining the quality relationship with partners through transparent and trusting communications, working with Program Management and site SLTs to provide unprecedented delivery. This role is accountable for the quality aspects of customer programs from initial discussions through end of program review/close. The AD, Program Quality works with customers to define quality requirements and governance for all programs, and agrees the process control strategy for the program, ensuring the right level of quality at the right time and demonstrates adaptability by ensuring processes meet regulatory requirements and support...

The Sr. Program Quality Manager is responsible for programs from the point of Quality Agreement signature through program closure. This role ensures Fujifilm Diosynth Biotechnologies, Holly Springs (FDBN) provides services in alignment with our contracted commitment to clients and our company vision/mission (strategy and compliance). This role is the primary client liaison representing FDBN Quality. The Sr. Program Quality Manager handles an average load of 1-3 programs and receives coaching & guidance from the Senior Director, Global Program Quality.