FUJIFILM

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Job Locations US-CA-Santa Ana
Posted Date 1 week ago(7/21/2021 6:37 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring a Validations Manager. The Validations Manager will manage the Company’s Validation department and certain aspects of the Quality Assurance department. Validation responsibilities and activities include, management of Validation Specialists and company master validation plan, to ensure all company processes, equipment and products are properly verified and validated per GMP, 21CFR part 820 and ISO 13485 requirements. Quality Assurance responsibilities to include, but are not limited to, assisting in the management and improvement of product quality, quality systems, supplier/material quality, and audit actions. The person in this role will ensure that required quality exists in all QA and Validations functions as prescribed to ISO13485, QSR, Brazil, MDD 93/42, IVDD 98/79/EC, Canadian Device Regulations, Australia, and other regulations as appropriate for where company registers and distributes product.   **#CB
Requisition ID
2021-15550
Job Locations US-CA-Santa Ana
Posted Date 1 week ago(7/21/2021 6:29 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring for a Quality & Technical Engineer. This role is a critical position to the Quality Systems and Regulatory team. The Quality & Technical Engineer provides statistical information for quality improvement by identifying and implementing efficiencies, such as new or improvements for assay method identification, development and transfers to GMP, Stability Program, Risk Assessments of the various product and processes changes with focus on leading and driving continuous improvement with the objective to build capability within the organization to eliminate risk and improve efficiencies.   **
Requisition ID
2021-15549
Job Locations US-CA-Santa Ana
Posted Date 1 week ago(7/21/2021 6:15 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring a Program Manager – Six Sigma Black Belt in our Research and Development group. As the company grows rapidly, we are seeking an individual to manage annual A3 Value Stream Map (VSM), execute multiple Kaizen monthly with 90-day tracking for sustainability, drive +QDIP KPIs consisting Safety, Quality, Delivery, Inventory & Productivity to create flow, and reduce defects. This Program Manager will drive targeted, balanced improvement in +QDIP that is tied to FUJIFILM Irvine Scientific’s corporate objectives using Lean tools, consulting skills, and the change management process. This person will drive site / company Leadership in the development of a +QDIP to drive production flow and to reduce muda. The Program Manager will directly provide formal and informal Lean Six Sigma training and coaching, and will be an active Leader in corporate objectives and monthly metric reviews (as appropriate).   **
Requisition ID
2021-15548
Job Locations US-CA-Santa Ana
Posted Date 1 week ago(7/21/2021 6:07 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring a Program Manager in our Research and Development group. The Program Manager will plan, manage and coordinate R&D projects in a new product development program to ensure that overall program goals are met. The person in this role will lead large, complex product development efforts for multiple projects aimed at developing and manufacturing GMP-grade cell culture media, reagents and devices used for the production of biotherapeutics (e.g. monoclonal antibody therapies and vaccines), regenerative medicine therapies (including stem cell therapy), and assisted reproductive technologies (ART). The Program Manager will be responsible for all new product development activities from Concept through Product Launch, as well as tracking and reporting on post-launch activities.   **
Requisition ID
2021-15547
Job Locations US-CA-Santa Ana
Posted Date 1 week ago(7/21/2021 5:54 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring for an Assistant Program Manager. The Assistant Program Manager will provide support to and manage and oversee the status of all R&D project level activities in a new product development program to ensure the overall program goals are met. This position will engage in various activities relating to new product development and product launch support.   **
Requisition ID
2021-15546
Job Locations US-CA-Santa Ana
Posted Date 1 week ago(7/21/2021 5:49 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring a Regulatory Affairs Manager – Cell & Gene Therapy (CGT). The Regulatory Affairs Manager – CGT will provide regulatory support and expertise for Cell and Gene Therapy (CGT) and Bioproduction (BP) product lines. The person in this role will ensure that product, process, and procedures are sufficiently controlled to assure the quality of products and compliance. The Regulatory Affairs Manager will also assist and provide support to customers with their regulatory submissions as needed. This person will also ensure that requirements are met in all regulatory functions as applicable to CGT and BP products by the FDA’s GMPs (QSR), ISO 13485, Health Canada and related cell and gene therapy product line requirements in all countries where product is distributed.    **
Requisition ID
2021-15545
Job Locations US-MA-Boston | US-NY-New York City | US-NJ | US-PA-Philadelphia
Posted Date 1 week ago(7/21/2021 1:04 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring a Field Application Scientist (FAS) – Single Use Technology (SUT). The FAS-SUT will provide pre and post sales service support to our customers. The FAS will be required to lead FAT and SAT related activities for our SUT products. Additionally, the FAS position may be required support the Bioproduction Sales Team/Technical sales Team to ensure SUT product adoption goals in terms of meeting business and financial goals. The person in this role will be responsible for supporting new sales at targeted accounts, as well as expansion and maintenance of existing customers in order to achieve departmental and Corporate Plan within the Unites States. The ideal candidate will be based in Boston, New York, New Jersey, or Philadelphia.   **
Requisition ID
2021-15541
Job Locations US-MA-Boston | US-NY-New York City | US-PA-Philadelphia | US-CA-San Francisco | US-CA-San Diego | US-NC-Raleigh | US-DC-Washington
Posted Date 1 week ago(7/21/2021 12:35 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring a Technical Sales Specialist (TSS) – Single Use Technology (SUT). The TSS-SUT will work with customers and sales teams to position Fujifilm’s SUT capabilities within the Biopharma/Biotech sector, maximizing the sales of single use hardware, automation, and consumables for the Fujifilm business within United States. The person in this role will be responsible for supporting new sales at targeted accounts, as well as expansion and maintenance of existing customers in order to achieve departmental and Corporate Plan. This is a field sales position which will cover North America, and the ideal candidate will be based near one of the major Biotech hubs (Boston, NY/NJ, Philadelphia, Washington, RTP, San Francisco Bay Area, San Diego)   **
Requisition ID
2021-15540
Job Locations US-CA-Santa Ana
Posted Date 1 week ago(7/21/2021 12:09 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring a Sr. Product Manager – Single Use Technology (SUT). The Sr. Product Manager will oversee all aspects of the marketing business and support the Director, New Market Development - Single Use Technology with their basic function. The person in this role will also support the team with strategic and tactical assignments as needed. The Product Manager’s work will encompass the broad range of activities required to plan, promote, and execute sound sales and marketing campaigns to achieve forecasted sales in the product portfolio assigned. This position interacts with varying levels of internal and external personnel and will require direct customer communication, public presentation, and a team-focused approach.   **
Requisition ID
2021-15537
Job Locations US-CA-Santa Ana
Posted Date 2 weeks ago(7/19/2021 5:56 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring for a Validations Specialist. The Validations Specialist performs necessary and appropriate process and equipment qualifications, studies and validations as a requirement for the manufacture of quality products. This includes validation of processes and equipment, process investigations, technical evaluation with regards to, but not limited to FDA/EU/CMDR compliance.   **
Requisition ID
2021-15517
Job Locations US-CA-Santa Ana
Posted Date 2 weeks ago(7/19/2021 5:53 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring for a Senior Analytical Scientist. The Senior Analytical Scientist should be experienced in Analytical Chemistry, and will conduct research leading to the development of new products.   **
Requisition ID
2021-15516
Job Locations US-CA-Santa Ana
Posted Date 2 weeks ago(7/19/2021 5:38 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring a Marketing Support Specialist – Assisted Reproductive Technology (ART). The Marketing Support Specialist will provide support in all functions in the marketing of ART products. The person in this role will work as an interface between marketing and necessary internal departments to support the Product Line Manager in achieving objectives.   **
Requisition ID
2021-15515
Job Locations US-CA-Santa Ana
Posted Date 2 weeks ago(7/19/2021 5:14 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring a Technical Support Specialist – Single Use Technology (SUT). The Technical Support Specialist will perform pre and post-sales support of scientific instruments, along with installation and service of equipment at customer sites. The person in this role will be responsible for supporting new sales at targeted accounts, as well as expansion and maintenance of existing customers in order to achieve departmental and corporate plan.   **
Requisition ID
2021-15514
Job Locations US-CA-Santa Ana
Posted Date 2 weeks ago(7/19/2021 4:50 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring for a Product Manager, Assisted Reproductive Technology (ART). The Product Manager oversees all aspects of the ART business as assigned and supports the Marketing Manager, ART and Assoc. Director of Marketing, with their basic function. This role will be interacting with varying levels of internal and external personnel and requires direct customer communication, public presentation, and a team-focused approach. Strong business, account and internal team focus is essential. The Product Manager’s work encompasses a broad range of activities required to plan, promote, and execute sound sales and marketing campaigns to achieve forecasted sales in the ART market. In addition, the Product Manager serves as the internal expert for the product lines and provides strategic guidance and direction for the positioning of Fujifilm Irvine Scientific’s products.   **
Requisition ID
2021-15513
Job Locations US-CA-Santa Ana
Posted Date 2 weeks ago(7/16/2021 3:12 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring a Liquid Prep Technician. The Liquid Prep Technician will perform controlled room disinfection/prep and set up, assist with Product Inspection, Labeling, Case Packaging, Accountability and Quarantine of Sterile Filled Product. In addition, this person will perform inspection and label application for all filled product, case packaging of all sterile filled products into appropriate boxes, bottle/vial preparation and staging.   **
Requisition ID
2021-15490
Job Locations US-CA-Santa Ana
Posted Date 2 weeks ago(7/16/2021 2:48 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring for a Regulatory Affairs Specialist. The Regulatory Affairs Specialist will assist and coordinate the compilation, preparation and assembly of regulatory submission and support files for medical devices and in vitro diagnostics registration worldwide in accordance with GMP, ISO 13485, MDD 93/42/EEC, IVD D 98/79/EC, ISO 14971, Canadian Medical Device Regulation, and related country regulations for medical devices and in vitro diagnostics. These activities include: Technical Files, Risk Management, FMEA, Essential Requirements, outside references and various regulatory external and internal support as required. The Regulatory Affairs Specialist will ensure that requirements are met in all regulatory and registration functions as prescribed by the FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada MDR and related medical device and in vitro diagnostics requirements.   **
Requisition ID
2021-15488
Job Locations US-CA-Santa Ana
Posted Date 2 weeks ago(7/16/2021 2:39 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring a Clinical Affairs Specialist. The Clinical Affairs Specialist will be responsible for the development and generation of Clinical Evaluation Plans and Reports (CEPs, CERs), clinical literature searches,  analysis of clinical literature, and evaluation and review of clinical data, generated both pre and post-market for medical devices and in vitro diagnostic devices. In addition, the Clinical Affairs Specialist will perform annual activities associated with Post Market Surveillance (PMS) program, including but not limited to, preparing and writing plans, reports and Post Market Clinical Follow-Up (PMCF).The person in this role will ensure that requirements are met in all regulatory and registration functions as prescribed by the FDA’s GMPs (QSR), ISO 13485, MDR 2017/745, IVDD 98/79/EC, IVDR 2017/746, Health Canada and related medical device and in vitro diagnostics requirements in all countries where products are registered and distributed.   **
Requisition ID
2021-15487
Job Locations US-CA-Santa Ana
Posted Date 2 weeks ago(7/16/2021 2:29 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring a Technical Specialist Supervisor. The Technical Specialist Supervisor ensures that recipes, process, and procedures are reviewed and processed assuring quality of products and compliance in accordance with GMP and ISO13485.  This person also monitors technical elements of manufacturing documents.   **
Requisition ID
2021-15486
Job Locations US-CA-Santa Ana
Posted Date 2 weeks ago(7/16/2021 2:08 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring for two Environmental Monitoring Technicians (one 1st shift, one 2nd shift). The Environmental Monitoring Technician performs tests for monitoring environmental conditions throughout the facility during sterile filling activities and maintains all documentation for tracability. The person in this role will also perform designated testing, monitoring, calibration, and maintenance of lab equipment in conjunction with approved procedures and test methodologies.    **
Requisition ID
2021-15485
Job Locations US-CA-Santa Ana
Posted Date 3 weeks ago(7/9/2021 2:36 PM)
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.   We are hiring a Sr. Manager – Financial Planning & Analysis. The Sr. Manager – Financial Planning & Analysis manages, prepares, administers and directs the control of the budget. This role requires excellent communication skills - both verbally and in written form – to explain budget and forecast details to Senior Management. The Sr. Manager will effectively explain variances against budget, forecast or prior year. This person also manages the activities of the financial analyst staff, and reviews and approves recommendations for financial planning and control, providing relevant fiscal information to the executive management team. Additionally, the Sr. Manager is responsible for developing and managing internal financial audits of various business operations. This person will develop a formal reporting system to communicate results of audit activities to management and regulatory compliance agencies, and may be called upon to provide leadership and technical guidance for compliance with JSOX compliance. In addition, the Sr. Manager selects, develops and evaluates personnel to ensure the efficient operation of the function.   **
Requisition ID
2021-15442