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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 Sr. Analyst 1, QC Virology works with limited direction to execute QC analytical methods requiring aseptic technique, including viral infectivity assays, mammalian cell culture, growth and purification of viral stocks, titering of viral stocks, and PCR-based methods. The Sr. Analyst 1, QC Virology adheres to GMP-compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identifies laboratory exceptions, invalid assays, deviations, change controls, and corrective and preventative actions (CAPAs). The Sr. Analyst 1, QC Virology is primarily responsible for executing routine Virology methods in support of manufacturing, supporting laboratory execution of method qualifications, maintaining cell banks and...
The QA Specialist, Supplier Quality is responsible for the day-to-day activities of administering Supplier Quality activities. This role acts as a point of contact for supplier quality and maintains supplier quality agreements, familiarity with audit programs, and vendor management processes. The QA Specialist, Supplier Quality administers approved supplier lists for the Holly Springs, NC site. This role collaborates internally with multiple QA teams, including Supplier Quality and site-based customers Supply Chain teams to manage and provide updates to suppliers.
The Utility Maintenance Apprentice role is an active position aimed at aiding the Utility Maintenance team in maintaining, troubleshooting, and repairing crucial equipment within a pharmaceutical manufacturing setting. Working under the supervision or guidance of experienced technicians and engineers, the apprentice gains expertise in ensuring the dependable operation of utilities such as HVAC, water purification, compressed air, steam, and other vital systems required for pharmaceutical production. This apprenticeship program offers thorough training and skill enhancement in technical areas vital to Utility Operations in the biotech pharmaceutical industry.
The Senior System Manager role is part of diverse Global IT department, which is driving digital transformation across the organization. As part of the Global ERP & Enterprise Services team, this role plays a key role in maintaining and developing the DSM Scheduling System, crucial for streamlining our drug substance production. This role also collaborates closely with team to ensure efficient, compliant IT services, working primarily with SQL, Alteryx, and Tableau. This role captures deployment requests, develop new system features, and strategize alongside our global team. Our culture, defined by Genki, champions simplicity, agility, and a community thriving on diversity and complex...
Provides field technical support for key account and/or strategic customers on all aspects of established and new products. Visits customer sites regularly to solve problems, build relationships, understand specific support requirements, and lead application development activities. Provides and coordinates technical training for customer personnel. Assists Sales, Business Development, and other staff in the practical application of company products to meet customer needs. Provides support in disseminating technical information for specific applications. Travel will average at least 50% through serving select, top tier customers within assigned...
Provides field technical support for key account and/or strategic customers on all aspects of established and new products. Visits customer sites regularly to solve problems, build relationships, understand specific support requirements, and lead application development activities. Provides and coordinates technical training for customer personnel. Assists Sales, Business Development, and other staff in the practical application of company products to meet customer needs. Provides support in disseminating technical information for specific applications. Travel will average at least 50% through serving select, top tier customers within assigned...
Provides field technical support for key account and/or strategic customers on all aspects of established and new products. Visits customer sites regularly to solve problems, build relationships, understand specific support requirements, and lead application development activities. Provides and coordinates technical training for customer personnel. Assists Sales, Business Development, and other staff in the practical application of company products to meet customer needs. Provides support in disseminating technical information for specific applications. Travel will average at least 50% through serving select, top tier customers within assigned...
The Senior Synapse System Administrator I (SSAT) is primarily responsible for education (internal and external) as it relates to Synapse System Administration. This includes the development of professional-grade training material, innovative training strategies and comprehensive training curriculums. In addition, this role is responsible for assisting with developing, and participating in all system administration training offerings, e.g., Q & A sessions, hosted and on-site courses.
Fujifilm Dimatix, Inc. strives to offer a healthy work environment that promotes individual responsibility and growth, a collaborative spirit, and an atmosphere that encourages learning, professional development and achievement.
The Regional Associate Director, Finance Business plays a pivotal role in providing financial leadership and strategic support to the commercial and program management teams within our North Carolina sites. This position requires a blend of financial expertise, business acumen, commercial mindset and the ability to influence and drive strategic initiatives. This role leads the local Finance Business Partner team in supporting all financial elements relating to revenue recognition, contract review/approval and sales to program margin analysis and forecasting. They are also responsible for ensuring financial goals are met and business strategies are effectively implemented. This role requires...
The Senior Environmental, Health & Safety (EHS) Specialist will lead EHS and sustainability programs at the Santa Clara, CA facility, driving improved performance through implementing EHS programs, ensuring KPIs are met and investigating all incidents /near miss. The position will also be responsible to ensure all environmental and compliance requirements for the facility are met. The position is also responsible to lead the safety committee and conduct relevant training for the employees.
Fujifilm Dimatix, Inc. strives to offer a healthy work environment that promotes individual responsibility and growth, a collaborative spirit, and an atmosphere that encourages learning, professional development and achievement.
The Commercial Development Director, (internally known as Commercial Development Manager) will be responsible for business development activities and to identify, manage the initial qualification, and close through the signing of contracts for new business, concentrating on Biologics.
The Sr. Supply Chain Planner 1 oversees the full life cycle of material management, while ensuring the operations of GMP Purchasing and Supply Chain Planning. The role leads collaboration with multiple departments to ensure the right materials are available at the right time, in the correct quantity to support GMP production. The Sr. Supply Chain Planner 1 clearly communicates expectations of delivery plans to Manufacturing, Process Science, Tech Transfer, and Quality. This role supports the operations of GMP Purchasing and Supply Chain Planning, including coordinating with the...
The Digital Radiography Sales Specialist is the regional DR and CT expert for all technical and clinical aspects of DR and CT products. He/she is responsible for the communication of all critical technical and clinical knowledge and expertise to the sales team for Digital Radiography and CT products.
The Digital Radiography Sales Specialist is the regional DR and CT expert for all technical and clinical aspects of DR and CT products. He/she is responsible for the communication of all critical technical and clinical knowledge and expertise to the sales team for Digital Radiography and CT products.
The CQV Engineer 3 supports the commissioning and qualification of equipment and systems for the site. This role performs validation activities to include but not limited to equipment set up, building dashboards, creating work orders, managing protocols, and reading and reviewing documents. This role ensures equipment and systems comply with regulatory requirements and quality standards while ensuring a successful integration of CQV activities into site projects.
About the Role
The Scientist 1, QC Chemistry is responsible for QC analytical chemistry methods used in biological product manufacturing, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The Scientist 1, QC Chemistry ensures GMP-compliant laboratory operations in accordance with regulatory guidelines. This role performs...
We have an exciting opportunity at our Carrollton, Texas facility for a QC Chemist. This position serves as a Quality Control Chemist and maintains quality standards by performing analytical testing on incoming and finished products for composition and impurities, as well as recording quality results.
In addition, this role will accommodate preparations for new formulations (Gauge studies, method development, instrument installation, etc).