Summary: Laboratory Engineering Technical Support I is an entry-level position in the Laboratory Engineering department of FDBT.  The primary purpose of this position is to provide day-to-day technical support for the analytical pcs and equipment within Manufacturing, Quality Control, Analytical and Process Development organizations.  In addition, this position is a major contributor to supporting new technology and equipment life cycle monitoring.  Under...

The Senior Financial Business Partner provides strategic financial support to the business. This position requires a blend of financial expertise, business acumen and the ability to influence and drive strategic initiatives. This role acts as a key advisor to the Program Management leadership, supporting all financial elements relating to revenue recognition accounting, contract review and approval and sales to program margin forecasting. This role is also responsible for ensuring financial goals are met and business strategies are effectively implemented. The role involves engaging with business partners to understand business processes, performance, highlighting risks and opportunities, and...

The Manufacturing Support Associate 1 performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.   

The Manufacturing Specialist 2, MES & DCS performs manufacturing support activities to ensure compliant and reliable production. This role focuses on aspects of recipe configuration and troubleshooting related to DeltaV Distributed Control Systems (DCS) and Manufacturing Execution System (MES). The manufacturing facility will be 24/7 operational and the role may require flexibility with working hours and shift rotation.

The Manufacturing Specialist 2, SAP performs manufacturing support activities to ensure compliant and reliable production. This role focuses on aspects of recipe configuration and troubleshooting related to Systems, Applications, and Products in Data Processing (SAP) material transactions. This manufacturing facility will be 24/7 operational and the role may require flexibility with working days and/or nights and shift rotation.

The Specialist, Quality Control supports Fujifilm Diosynth Biotechnologies California (FDBC) QC withthe business analysis, design, development, implementation, validation, and support of existing and new Laboratory Information Management Systems (Labware LIMS) and other lab applications.  The Specialist, Quality Control is a customer facing role, working in close collaboration with Quality Control (QC), Quality Assurance, Manufacturing, and Information Technology (IT) teams. The Specialist will follow FDBC methodologies for systems and project governance, leverage tools &...

The Sr. Specialist, Quality Control supports Fujifilm Diosynth Biotechnologies California (FDBC) QC withthe business analysis, design, development, implementation, validation, and support of existing and new Laboratory Information Management Systems (Labware LIMS) and other lab applications.  The Sr. Specialist, Quality Control is a customer facing role, working in close collaboration with Quality Control (QC), Quality Assurance, Manufacturing, and Information Technology (IT) teams. The Sr. Specialist will follow FDBC methodologies for systems and project governance, leverage...

The Specialist, QA Documentation Management will support the site documentation management program. The role is responsible to have intermediate knowledge of regulations concerning Good Documentation Practices (GMP) to ensure compliance to quality standards for documentation, training, and records management. Responsible to support the documentation management curriculum structure and assist in the delivery of effective documentation practices to end users, multi-task across multiple functional areas, and can be flexible to meet the demands of a multi-product clinical phase cellular therapy company that is transitioning toward commercial phase.

The Director Quality Systems is responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT.  Responsibilities will include one or more PQS sub-system: Deviation, CAPA, Change Control, Supplier Quality, Training, Document Control, QA Validation, eQMS, and Quality Management.  Lead the assigned team to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external stakeholders.  Ensure the site PQS sub-system is aligned with the harmonized global FDB PQS, organizational goals and objectives, and areas of continuous...

This position is responsible for the design, development, maintenance, and delivery of technical training for the Manufacturing organization. Also, the Manufacturing Training Specialist II will prepare training, design documents, and manage instructional design projects.

The purpose of this Global Category Manager role is to drive and foster a strategic mindset in one or more procurement categories across all FUJIFILM Diosynth Biotechnologies (FDB) sites by creating, communicating and implementing category strategies and plans. In this role, you will ensure transparency, structure and control in this category, enabling data-driven decision making as well as continuous cost and service improvements. You will manage the category's supplier portfolio and ensure that partner and key suppliers are globally contracted (MSA) at an advantage vs their T&Cs

The Automation Engineer 3, CIP & Clean Utilities, will support the Drug Substance Manufacturing (DSM) facility. This includes implementing changes to the automation systems, updating design documents, executing testing, troubleshooting events, and being a part of on-call automation support.   In the project...

The Senior Automation Engineer 1 will provide Engineering input on the design, implementation, configuration, and testing qualification of the hardware for an Emerson DeltaV control system. Once in Operations, you will be responsible for and have ownership of the ongoing support of the control system hardware, software, and infrastructure.

The IT Support Analyst 3 is responsible for all first level IT support to internal stakeholders (e.g., troubleshooting of incidents, escalation based on incident management procedures, handling of IT requests and user administration). This role helps to establish the IT Service Desk and participates in projects within IT. The IT Support Analyst 3 drives excellent service delivery and processes within IT, while collaborating with other FDB sites domestically and globally to ensure alignment across key areas

The Manager, QC Laboratory Information Management System (LIMS) is responsible for developing strategic plans for implementing FDB's global Laboratory Information Management System (LIMS). This role harmonizes processes across all current and future FDB sites and leads the transition of QC into a paperless environment. The Manager, QC LIMS guides a team of LIMS experts to translate global and site-specific needs into user requirements, system design, configuration, and implementation plans. This role acts as the primary subject matter expert (SME) for LIMS and focuses on maintaining and continuously enhancing the global LIMS system.

The IT Support Analyst 2 is responsible for all first level IT support to internal stakeholders (e.g., troubleshooting of incidents, escalation based on incident management procedures, handling of IT requests and user administration). This role helps to establish the IT Service Desk and participates in projects within IT. The IT Support Analyst 2 drives excellent service delivery and processes within IT, while collaborating with other FDB sites domestically and globally to ensure alignment across key areas

The Senior Financial Business Partner provides strategic financial support to the business. This position requires a blend of financial expertise, business acumen and the ability to influence and drive strategic initiatives. This role acts as a key advisor to the Program Management leadership, supporting all financial elements relating to revenue recognition accounting, contract review and approval and sales to program margin forecasting. This role is also responsible for ensuring financial goals are met and business strategies are effectively implemented. The role involves engaging with business partners to understand business processes, performance, highlighting risks and opportunities, and...

The Process Development (PD) Internship at Thousand Oaks, CA will assist with the planning, execution, data analysis, presentation, and report writing of internal process development studies. The person in this position will work closely with the site process and analytical development staff. The position may also support other study activities as required.

The Vice President of Engineering will be a business leader for the site engineering function. This pivotal role will be responsible for overseeing the engineering functions, including Automation, Process Engineering, Utilities, Commissioning, Qualification, and Validation (CQV), Environmental Health and Safety (EHS), Facility Management and Security, and Capital Projects. The executive role will join site leadership in leading the business and ensuring engineering teams support the business strategy and provide state-of-the-art technical solutions, support robust manufacturing processes, drive continuous improvement initiatives, and upholds the highest standards of quality...

Summary:  Under limited supervision of the Sr. Warehouse & Logistics Manager, the Warehouse Operations Manager is responsible for the efficient co-ordination and management of GMP warehouse operations in line with GDP / GWP.  The role will ensure accurate receipt, verification, record keeping, distribution, and shipment of materials to support GMP production. In this role, the Warehouse Operations Manager will liaise with internal and external stakeholders ensuring materials are staged in accordance with the Master Schedule, cycle counting is executed and manage a team of supervisors.