Director of Program Design Advanced Therapies will support the Sales and Program Design teams and partner with site technical and operations teams in acquiring new business for Fujifilm Biotechnologies Lifesciences. Internally and in collaboration with customers, the program design team provides technical guidance for customer program opportunities and are responsible for directing the proposal and program scoping processes.

The job holder will be focused on Fujifilm Biotechnologies’ Advanced Therapies business segment (i.e. cell and gene therapy) and will be US-based (remote or in proximity to FUJIFILM Biotechnologies sites).  Regular out of hours calls may be required and periodic travel to FUJIFILM sites (College Station, TX; Darlington, UK), industry conferences, and customer sites will be required. This a remote position based in Texas, USA. The candidate should be able to ideally travel regularly to our College Station, Texas facility.

Principal Accountabilities:

The job holder will be responsible for providing support to the acquisition of new customers:

• Responsible for leading the technical aspects of customer meetings and teleconferences
• Accountable for the review of RFPs and the design of customer programs, from Technology Transfer to cGMP manufacture and Process Validation.
• Perform assessment of customer programs to guide fit with Fujifilm capabilities and site requirements.
• Partner with site process sciences, engineering, and Quality teams in assessing customer programs.
• Prepare proposals in response to RFPs
• Define program scope, siting/location, timelines, and resources
• As needed, support the overall sales process, including SoW development, Stage Gates, Win Rooms, and customer meetings and requests
• As a Director you will lead and direct relevant aspects of the Program Design team’s improvement efforts and initiatives, including efforts to promote and maintain harmonization of work practices across sites
• Leading role in Program Design’s engagement with internal stakeholders and manufacturing teams to promote open communications and improvements of Fujifilm’s service offerings
• Attend webinars and conferences in support of FUJIFILM commercial teams, as well as keep up to date with current industry advancements

Education, Skills & Experience Requirements:

• A scientific degree or equivalent (e.g. BSc) and possibly also a higher degree (e.g. MSc, PhD) in a relevant biological science field (e.g. cell/molecular biology, biochemistry, virology)
• Understanding of modality-specific process development, analytics, scale-up, GMP manufacturing, and regulatory considerations for cell/gene therapy products.
• Minimum of 3+ years (Associate Director) and 5+ years (Director) of technical experience in an applicable role (e.g. within Fujifilm, other CDMO, or technical position) supporting the development of advanced therapy products.
• Experience in at least one of the following: cell-culture-based production, gene therapy, cell therapy virology, microbial production, purification, or analytical technology.
• Excellent written communication skills, accurate and concise and able to strike the balance between sales and technical writing.
• The ability to interact with external customers in a professional and personable manner and to present a competent image of Fujifilm at all times.
• Understanding of, and experience with cGMP manufacturing a plus.
• Ability to analyze complex technical problems and present clear solutions.
• Ability to influence customers and colleagues at all levels.
• Willingness and ability to travel regularly to our College Station, Texas facility.

Benefits

Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth!

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.