Research Development Process Engineer Jobs in Madison, WI

Lead Research & Development (R&D) organization to execute on business strategies, ensuring growth to meet sales and operating profitability goals. Reporting to the Chief Operating Officer, VP of R&D will oversee and enable innovation and product development across iPSC programming/line development, iCell portfolio, custom products, and CDMO services. As a key member of the Executive Leadership Team, creating agility and efficiency in resource management across R&D to ensure timely delivery of programs and initiatives. Builds talent and capabilities across R&D to ensure the current and future health of the organization, collaborating cross-functionally, and delivering a high level of performance.

At FUJIFILM Cellular Dynamics, we’re unlocking the power of human cells to change lives. Using revolutionary induced pluripotent stem cell (iPSC) technology, we drive advancements in drug discovery, disease modeling, cell therapy, research tools, and cell therapy manufacturing. Our mission is deeply meaningful, and we’re looking for bold innovators to join us.

At FUJIFILM Cellular Dynamics, you’ll thrive in a collaborative and cutting-edge environment that encourages creativity and celebrates breakthroughs. If you’re ready to do work that makes a real impact and propels healthcare forward, this is your chance to be part of something extraordinary for science, patients, and yourself.

Our headquarters is in Madison, Wisconsin, a dynamic city celebrated for its lakes, parks, cultural richness, biotech leadership, and access to world-class academia.

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

Essential Job Functions

• Oversee and deliver on R&D milestones, including Discovery Research new product development, CDMO milestones outlined agreements/SOWs, and DR custom projects
• Collaborate with Finance and Business Development to create and refine CDMO financial models to ensure profitable CDMO programs
• Plan and execute the development of new products and the improvement of existing products, in alignment with commercial team, and ensuring an efficient and effective NPI process is followed, and quality products are being released to the life science market
• Work closely with Executive team to develop and execute the long-term strategic business plan, ensuring communications to R&D team ang alignment to goal setting process
• Manage departments’ annual budgets and quarterly forecasting processes. Ensure sound management of head count and expenses to meet approved spending plan while achieving all departmental commitments, project objectives, and to drive operating profit for the company
• Identify, develop, and deploy best practices across all R&D functions, including advancing opportunities for innovation, finding ways to enhance development and accelerate time to market
• Communicate and manage program status, initiatives, roadblocks, and recovery plans with Senior Management to achieve projects on time and on budget
• Drive portfolio valuation process and prioritization analyses, and provide technical assessments and recommendations to optimize the return and risk of portfolio investments
• Facilitate where required, IND submissions and clinical development of partnered programs consistent with the highest regulatory standards
• Represent the company to prospective and current therapeutic/CDMO clients as the leader for iPSC and cell therapy development
• Drive innovation, ensuring FUJIFILM Cellular Dynamics stays a leader in advanced iPSC technologies and support to therapeutic developers.
• Support early-stage programs, including technology transfer, clinical manufacturing support, IND submissions, in partnership with therapeutic clients
• Drive execution of development programs and goals, developing and defining key “Go/No-go” criteria and managing matrix teams
• Proactively identify project issues and implement appropriate mitigation strategies. Ensure sound technical responses to information requests from regulatory bodies
• Implement key standard processes leading to positive and measurable impacts for clinical programs (e.g. quality, efficiency, consistency)
• Ensure employee engagement within and across teams in collaboration with HR and other senior management
• Select, develop, train, and retain capable staff of development and operations professionals to ensure all aspects of the company objectives and timelines are achieved
• In collaboration with HLUS Compliance, support the business in compliance issues, collaborating with other departments to ensure sound business continuity and planning.

Qualifications

• PhD in cell biology, molecular biology, biochemistry, biomedical engineering, or related field – stem cell experience a plus
• Minimum of 15 years of R&D experience in the pharmaceutical, biotech, life science or CDMO industry with at least 10 years of management/leadership experience
• Relevant experience building high-performing, cross functional teams responsible for optimizing portfolio delivery
• Strong familiarity with regulated pharmaceutical development and FDA, EMA, and other MOHs globally
• Ability to influence outcomes, utilizing effective communication skills across functions and on the executive team
• Demonstrated leadership capabilities to include a track record of hiring, retaining, developing and motivating top-tier scientific talent, team development, managing through adversity, effective communication across all levels of stakeholders to include external parties, all with a strategic outlook and ability to defend research positions while achieving program objectives
• Proven track record of driving accountability and fostering problem-solving within the team
• History of translating a corporate mission into specific team objectives, breaking down organizational boundaries through collaboration, building strong relationships based on trust with all levels of employees.
• Ability to become a strategic partner with business leaders; contributes not only by identifying strategic opportunities for R&D, but also demonstrates an ability to think beyond the status quo and conceptualize innovative and visionary approaches to broad business challenges
• Proficient in R&D planning and driving execution through the team
• Demonstrated proficiency in managing multiple projects, and changing priorities meet timelines and budgets
• Domestic and international travel – 10%

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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 (fcdi-hr@fujifilm.com).