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The Intern (Drug Substance Manufacturing (DSM) Support and Campaign Lifecycle Management) is part of the DSM support team tasked for preparing Campaign Readiness for Good Manufacturing Practice
Position Description
We are hiring a Powder Milling & Cleaning Tech. The Powder Milling & Cleaning Tech will be responsible for the milling of powdered media and cleaning of powder media equipment.
1st Shift: 5am - 1:30pm
The Manager, Digital Operations oversees the management and optimization of digital tools such as Manufacturing Execution Systems (MES), data historians, and e-logbooks within Drug Substance Manufacturing. This role involves strategic configuration, approval, and support of recipe-driven operations across one family unit operations (e.g., Upstream, Downstream, or Solutions). The Manager, Digital Operations drives continuous improvement of digital solutions by ensuring alignment with manufacturing processes, integration standards, and stringent regulatory requirements. The Manager, Digital Operations plays a crucial role in the tech transfer process, identifying platform capability gaps to...
The Manager, Digital Operations oversees the management and optimization of digital tools such as Manufacturing Execution Systems (MES), data historians, and e-logbooks within Drug Substance Manufacturing. This role involves strategic configuration, approval, and support of recipe-driven operations across one family unit operations (e.g., Upstream, Downstream, or Solutions). The Manager, Digital Operations drives continuous improvement of digital solutions by ensuring alignment with manufacturing processes, integration standards, and stringent regulatory requirements. The Manager, Digital Operations plays a crucial role in the tech transfer process, identifying platform capability gaps to...
The Manager, Digital Operations oversees the management and optimization of digital tools such as Manufacturing Execution Systems (MES), data historians, and e-logbooks within Drug Substance Manufacturing. This role involves strategic configuration, approval, and support of recipe-driven operations across one family unit operations (e.g., Upstream, Downstream, or Solutions). The Manager, Digital Operations drives continuous improvement of digital solutions by ensuring alignment with manufacturing processes, integration standards, and stringent regulatory requirements. The Manager, Digital Operations plays a crucial role in the tech transfer process, identifying platform capability gaps to...
The Sr. Analyst 1, QC Microbiology is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Analyst 1, QC Microbiology performs and trains other team members on the microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples. This role is responsible for all activities associated with testing in accordance with written procedures. This role primarily works independently with minimal supervision as needed, consults with management on key decisions.
The Analyst 1, QC Raw Materials is accountable for GMP compliant laboratory operations according to USP/EP/JP regulations. The role will be responsible for participating in the Technology Transfer of established methods into the FUJIFILM Biotechnologies, North Carolina Quality Control Laboratory. Following Tech Transfer Activities, the position will be responsible for performing raw material testing and disposition using the established analytical methods.
The Scientist 2, QC Analytical Development (AD) Chemistry is responsible for coordinating the transfer of analytical methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies, Holly Springs. The QC AD Chemistry Scientist 2 ensures GMP compliant laboratory operations in accordance with regulatory guidelines. This role coordinates analytical method transfers from clients, including the following analytical methods: chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and...
The Senior Analyst 1, QC Raw Materials is accountable for GMP compliant laboratory operations according to USP/EP/JP regulations. The role will be responsible for participating in the Technology Transfer of established methods into the FUJIFILM Biotechnologies, North Carolina Quality Control Laboratory. Following Tech Transfer Activities, the position will be responsible for performing raw material testing and disposition using the established analytical methods.
The Analyst, QC Virology is responsible for supporting QC analytical methods including cell culture, viral infectivity assays, growth and purification of viral stocks, viral titer, and qPCR-based methods. This role supports bioassay methods, including cell- and plate-based methods such as residual DNA, HCP, and protein binding assays. The Analyst, QC Virology generates and reviews Good Manufacturing Practices (GMP) testing results and assists in identifying laboratory exceptions, invalid assays, deviations, and corrective and preventative actions and identifies areas for laboratory improvement.
The Quality Control Bioassay Analyst works with direction from manager to execute QC cell- and plate-based analytical methods including protein binding assays, cell-based potency assays, cell culture routine maintenance, and residual testing for DNA, Host Cell Protein (HCP), Protein A/G. The QC Bioassay Analyst adheres to GMP compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identify laboratory exceptions, invalid assays, deviations, change controls and corrective and preventative actions (CAPAs). The QC Bioassay Analyst is primarily responsible for executing routine analytical methods in support of manufacturing, and as...
The Sr. Analyst 1, QC Microbiology is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Analyst 1, QC Microbiology performs and trains other team members on the microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples. This role is responsible for all activities associated with testing in accordance with written procedures. This role primarily works independently with minimal supervision as needed, consults with management on key decisions.
Position Description
We are hiring a Bioprocess Specialist Manager. The Bioprocess Specialist Manager will be responsible for sales and support for all FujiFilm Life Science Bioprocess products and
services in their region. This is an individual contributor position.
FUJIFILM Electronic Materials, U.S.A., Inc., is a global leader in chemical solutions which enable the semiconductor industry and the digital universe. We have an exciting opportunity at our North Kingstown, RI facility for a Warehouse Technician! This position would support our 3rd shift operations.
The Warehouse Technician is responsible for...
Position Description
We are hiring a Product Manager, Bio Production Catalog Media. The Product Manager, Bio Production Catalog Media will oversee product management activities for the portfolio and support the Senior Product Manager with strategic and tactical assignments as needed.
The Senior Manufacturing Project Lead leads and organizes manufacturing projects and support activities. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.
The Staff Accountant 2 supports the organization with accounting and finance related responsibilities by performing accounting analysis, preparing appropriate accounting and internal control documents. The Staff Accountant II plays a key role in understanding and interpreting customer contracts for accurately reporting and recognizing revenue. Additionally, this position interacts with and supports many of the accounting and finance areas of responsibilities
FUJIFILM Electronic Materials, U.S.A., Inc., is a global leader in chemical solutions which enable the semiconductor industry and the digital universe. We have an exciting opportunity for a Technical Marketing Manager!
With state-of-the-art manufacturing facilities in the U.S., Europe, Taiwan, China, Korea and Japan, local sales offices throughout the world and on-site applications support, FUJIFILM Electronic Materials supplies the world's top...
The Tech 1, Instrumentation & Controls (I&C) role is responsible for ensuring the efficiency and operational reliability of the instrumentation and controls that support facility-wide equipment, and facility systems through effective Corrective and Preventive (CAPA) Maintenance and Calibration practices and know-how.
The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. This role will also support projects which influence manufacturing processes for DPM including training of others. This position will also support and assist in scheduling daily manufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation.