The QA Associate Manager (Operations DSM Upstream) leads and supervises a team of QA professionals responsible for providing day-to-day risk-based QA support of Drug Substance Manufacturing areas and processes in a fast-paced, dynamic startup environment. This role is the primary point of contact for their team and the first-line escalation point in areas of their responsibility. This role requires collaboration with leadership, site-based customers, and global colleagues.

The Customer Sourcing Specialist is responsible for customer onboarding activities, coordinating material enrollment, supporting tech transfer, and sourcing activities for customer programs at FDBN. Support of the Denmark facility, as needed. This role is a key link between the global sourcing organization and customer program organization for matters related to risk assessment of materials, vendors, new materials, and vendor onboarding activities. This...

The Supply Planner supports the Senior Manager, Supply Planning in the development and maintenance of supply planning activities for FDBU. The primary focus of this position includes the scheduling and maintenance of the Master Manufacturing Production Schedule/Asset Plan along with the frequent review and assessment of opportunities and adjustments based on input from Manufacturing Leadership & Support Teams, Program Management, and Supply Chain. This position primarily coordinates with Manufacturing Leadership & Support Teams and other internal FDBU Teams (program managers, finance,...

The Manufacturing Associate 2 executes and documents manufacturing processing activities per cGMP environment. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.   While in project phase, the schedule will be Monday-Friday during normal...

The Associate Director of Program Management will be accountable for the planning and delivery of programs from the point of contract signature (Scope of Work/Letter of Intent/Contract) to program delivery, including technology transfer and taking a product/process from the execution of a client commercial agreement or memorandum of understanding through process development and early-stage clinical supply through program closure.  The Associate Director ensures the organization executes programs in alignment with contractual commitments to the clients and the company’s S&OP goals.

The QA Validation Specialist will serve as technical subject matter expert for FDBC validation processes including but not limited to, facilities, utilities and equipment qualification (FUE), manufacturing and laboratory systems and computerized equipment (CSV), and validation software tools.  The main responsibility for this role is to provide QA oversight for validation practices at FDBC.  The role will also provide QA oversight for validation related topics by supporting QMS processes and deliverables such as SOPs, site deviations, CAPAs and change control records. The role will work closely with manufacturing, quality control, quality assurance, supply chain,...

  Summary:  The QC Stability Coordinator III, will construct, maintain, and oversee the Quality Control Testing of Stability programs to include developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data. The Quality Control Coordinator III, under general direction, will be responsible for implementing a Quality Control Stability Program that will encompass the needs of the client for each program. The position will require frequent communication with the Chemistry, Cell Biology,...

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 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 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...

The Automation Engineer 3, DSM 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 Sr Automation Engineer 1, DSM DeltaV Infrastructure 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 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 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 general direction, the Materials Management III is responsible for the accurate receiving, ordering, shipping, general warehousing, and internal distribution of cGMP (current Good Manufacturing Practices) and non-GMP materials in support of company operations.

Summary:  Under direct supervision, the Materials Management Specialist I is responsible for supporting receiving, ordering, shipping, general warehousing, and internal distribution of cGMP (current Good Manufacturing Practices) and non-GMP materials in support of company operations.