We are hiring a R&D Project Manager I. The R&D Project Manager I will execute calculated risks and overcome challenges. They will plan, manage and coordinate R&D projects in a new product development Project to ensure that overall Project goals are met, 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). They will be responsible for all new product development activities from concept through product launch, as well as tracking and reporting on post-launch activities.

At FUJIFILM Irvine Scientific, we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world’s biggest health challenges.

Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you’re ready to make an impact, your future belongs with us at FUJIFILM Irvine Scientific.

Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Responsibilities

• Coordinating and reporting on all project activities according to project scope, timelines and
• 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.

Required Skills/Education

• B.S. in Project Management, Cell Biology, Biochemistry, Biotechnology, Chemistry, Biomedical Engineering or equivalent.
• 5+ years relevant experience in industry or academic environment.
• 3+ years in Project Management in New Product Development utilizing a formal phase-gate process with demonstrated success preferred.
• 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.
• 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 preferred.
• Experience in technology licensing and contract negotiation.
• A Project Management certification such as a PMP certification preferred.
• Ability to speak, read, and write in English.
• Good oral and written communication skills and good presentation skills.

Salary and Benefits:

• For California, the base salary range for this position is $82,353 - $107,363. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off

*#LI-onsite

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (fisihr@fujifilm.com).