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 R&D Project Manager II who can execute with calculated risks and overcome challenges with the Can-Do attitude. This position will plan, manage and coordinate R&D projects in a new product development Project to ensure that overall Project goals are met. This position will also 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), and regenerative medicine therapies (including stem cell therapy). This position is responsible for all new product development activities from Concept through Product Launch, as well as tracking and reporting on post-launch activities. This position will manage any other projects assigned by Supervisor.
- Coordinating and reporting on all project activities according to project scope, timelines and budget.
- Coordinating and managing routine new product development team meetings.
- Reporting project status of the Project to new product development committee (NPC) consisting of a senior level management team that manages the product portfolio.
- Maintaining knowledge of technologies appropriate for managing the development process for new products.
- Working across departments (cross-functionally) with key team members to complete projects.
- Working with the finance and marketing core team members to develop the financial analysis for projects, and to gather information justifying each product’s potential for commercial success.
- Working with cross-functional teams to efficiently and effectively complete projects on schedule and within approved budgets.
- Working with the operations team to efficiently and effectively transfer products from R&D to manufacturing.
- Communicating effectively with R&D management, commercial (sales and marketing), quality, regulatory, manufacturing, finance, and legal.
- Working to ensure that the project teams stays on track to deliver on objectives, meet timelines and stay within budget.
- Managing all stakeholders’ expectations.
- Ability to influence across departments without direct authority
- Providing needed administration support to all R&D new product development projects.
- Communicating externally with regulatory agencies, notified bodies, competent authorities, collaborators, vendors, beta-site testers, and customers on an as needed basis.
- Position requires substantial independent judgment, creativity and self-motivation.
- BS. in Cell Biology, Biochemistry, Biotechnology, Chemistry or equivalent.
- 5+ years relevant experience in industry or academic environment.
- 5+ years in Project Management in New Product Development utilizing a formal phase-gate process with demonstrated success
- Strong understanding and practical knowledge of Design Control including, but not limited to, design input, design output, verification and validation process, drug master files, risk assessments, technology transfer from R&D into manufacturing, and producing quality products that meet customers’ needs.
- Strong understanding of GMP and GLP is highly preferred.
- Understanding of cell culture media business environment is preferred.
- Understanding of cell culture techniques, technologies, concepts, practices and procedures is desirable.
- Strong problem-solving ability with can-do attitude.
- Ability to build collaborative relationships and facilitate a collaborative environment.
- Ability to work with team to address challenges, trouble-shoot and deliver on action items.
- Highly proficient in Microsoft Excel, Word, PowerPoint, Outlook, and Microsoft Project (or equivalent software).
- Excellent verbal, written, electronic communication, and oral presentation skills are required.
- Ability to communicate and interact at all levels from senior management to staff level.
- Experience in a regulated industry such as medical devices.
- Experience in technology licensing and contract negotiation.
- A Project Management certification such as a PMP certification.
- Experience in hiring and directly managing employees is desirable.
- Ability to speak, read, and write in English.
- Good oral and written communication skills and good presentation skills.
FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
- Cell Cultures
- Certified Project Management Professional