Associate Director/Director, Program Design Biologics
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Skills: Program Design, Biologics Manufacturing, Technology Transfer, cGMP Manufacturing, Process Validation
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Other
bachelor degree, postgraduate degree
Posted 30d ago
Apply by Jul 9
~40 hrs/week
Responsibilities
Lead the technical design of customer-tailored biologics programs from technology transfer through cGMP manufacturing and validation. Partner with commercial and operational teams to translate client needs into high-quality proposals and drive new business growth.
Requirements
Requires a bachelor's degree in biological sciences and 8+ years of technical experience in the pharmaceutical or biotechnology industry. Must have a strong understanding of CDMO models, cGMP requirements, and the ability to lead technical client discussions.
Full job description
Company Overview
The work we do at FUJIFILM Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Biotechnologies and help make the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what we call Genki. 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
Overview
We’re growing and seeking an accomplished biologics professional to join our Program Design team. In this role, you will partner closely with our global commercial sales organization and site technical/operations teams to shape winning, customer‑tailored programs—from technology transfer through cGMP manufacturing and process validation.
You will lead technical discussions with prospective and current clients, translate complex needs into clear program designs and proposals, and help drive new business across FUJIFILM Biotechnologies sites.
Associate Director or Director will be aligned to your experience; the Director level may include people leadership and broader cross‑site improvement initiatives.
External US
What You’ll Do
Lead the technical aspects of customer meetings and teleconferences, projecting FUJIFILM’s experience and expertise.
Review RFPs and design customer programs spanning process development, technology transfer, cGMP manufacturing, and process validation.
Assess customer programs for fit with FUJIFILM Biotechnologies’ capabilities and site requirements.
Partner with site operational/technical teams to evaluate program feasibility and requirements.
Prepare high-quality proposals in response to RFPs, tailored to customer goals and constraints.
Define program scope, siting/location, timelines, and resource needs in alignment with internal and client stakeholders.
Support the overall sales process as needed, including SoW development, internal commercial processes, and customer requests.
Engage proactively with internal stakeholders and manufacturing teams to promote open communication and enhance our service offerings.
Stay current with industry advancements; attend webinars and conferences in support of FUJIFILM commercial teams.
At the Director level, lead and direct Program Design team improvement efforts, including harmonization of work practices across sites.
At the Director level, manager 1-3 direct reports supporting the FUJIFILM Biotechnologies business.
Other duties as assigned.
Required Qualifications (Education and Experience)
Education: Scientific degree (Bachelor’s degree) in relevant biological science field.
Experience:
8+ years of technical experience in the pharmaceutical/biotechnology industry.
Broad understanding of CDMO business models and Biologics manufacturing (Microbial and/or Mammalian).
Working knowledge of the regulatory environment, process development, and analytical technologies for biopharmaceutical manufacturing.
Demonstrated understanding of, and experience with, cGMP manufacturing and associated requirements.
Excellent written and verbal communication skills with the ability to interact with external customers in a professional and personable manner and to present a competent image of FUJIFILM at all times.
Proven ability to analyze complex technical problems and present clear, actionable solutions.
Ability to influence and collaborate effectively with customers and colleagues at all levels.
Any combination of education and experience, which would provide an equivalent background to deliver against role expectations.
Preferred Qualifications
Education: Advanced scientific degree (e.g. MSc or PhD) in a relevant biological science field.
Experience:
6+ years of technical experience in a CDMO or closely related biopharmaceutical environment; experience working directly with customers in a client-facing capacity.
Prior experience within FUJIFILM Biotechnologies or another biologics CDMO.
Direct experience designing end-to-end programs from technology transfer through validation within a commercial environment.
Leadership experience, especially cross-site harmonization and/or managing a small team (for Director consideration).
Who You Are:
A customer-centric problem solver who thrives at the intersection of science, operations, and business development.
A clear communicator who can translate complex scientific concepts into compelling, solution-oriented proposals.
A collaborative partner who builds trust with technical, quality, and commercial teams to deliver on shared goals.
Why Join FUJIFILM Biotechnologies
Impact: Shape high-value biologics programs and help customers bring important therapies to patients.
Growth: Role scope and title (Associate Director or Director) tailored to your background, with opportunities to lead cross-site initiatives and people.
Collaboration: Work with a global, multidisciplinary team across leading biologics sites.
Research shows that some candidates hesitate to apply unless they check every box. If you’re excited about this role and have relevant experience in biologics/CDMO environments—even if your past experience doesn’t align perfectly with every requirement—we encourage you to apply. We’re committed to building a diverse, inclusive, and authentic workplace and welcome applicants from all backgrounds, including internal candidates exploring career 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.
EEO Information
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.
ADA Information
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 ([email protected]).
Related keywords
BiologicsCDMOcGMPTechnology TransferProcess ValidationMicrobial ManufacturingMammalian ManufacturingRFPStatement of WorkBiopharmaceuticalProcess DevelopmentAnalytical TechnologiesProgram DesignPharmaceuticalsBiotechnologyClient-Facing
FUJIFILM Electronic Materials supplies the world's top tier semiconductor manufacturers with a broad array of products.
Industry
Chemical Manufacturing
Company size
501-1,000 employees
Headquarters
North Kingstown, RI
LinkedIn followers
8,914
FUJIFILM Electronic Materials develops and manages chemical formulations that power the most critical processes of semiconductor technology. We are a diverse, global supplier that delivers tailored support where our customers need us most. The spirit of partnership drives everything we do — our commitment to the continued success and innovation of our customers is our primary focus. Through state-of-the-art systems, leading-edge technologies, and a commitment to the continuous development of environmentally friendly processes, FUJIFILM Electronic Materials is:
DEDICATED — to the success of our customers and team
CURIOUS — with a genuine interest in finding new ways to innovate
DRIVEN — motivated to push the boundaries of possibility
COLLABORATIVE — committed to working jointly to develop the best solutions
Headquartered in Yokohama, Japan, FUJIFILM Electronic Materials has 11 regional offices globally. As proud members of the FUJIFILM Group, we are one of the leading and most trusted producers of the chemical formulations that enable our partners to progress semiconductor technology to the next node and beyond. Our assured, stable supply is proven through our state-of-the-art quality system. Leveraging leading-edge technologies, our formulations help to power cell phones, computers, medical devices, cars, refrigerators and other goods essential to human life.
The engineers, scientists, manufacturing staff and other professionals who commit their skills and intellect to FUJIFILM Electronic Materials strive to make a difference in their jobs and in the world. Our organization offers the opportunity to pursue challenging and meaningful work in an environment that supports growth. With an internal culture that prioritizes teamwork, open communication and shared success, FUJIFILM Electronic Materials inspires both personal and customer advancement.
Offices: 80 Circuit Drive, North Kingstown, RI 02852, US · 6550 South Mountain Road, Mesa, AZ 85212, US · 1200 W Jackson Rd, Carrollton, Texas 75006, US · 1160 Commercial Pkwy, Castroville, California 95012, US · 250 William White Blvd, Pueblo, Colorado 81001, US
CMP SlurriesCleaners and EtchantsCVD PrecursorsPhotoresistsImage Sensor Color MosaicPhotoresist AncillariesPolyimides and PBO'sHigh Purity Primary SolventsPhotovoltaic Precursorsand Photovoltaic Precursor Equipment
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