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Senior Analytical Development Scientist

Job Location:

Madison, OH - USA

Monthly Salary: Not provided by the employer

Posted: 30 August 2026 (18 hours ago)

Application Deadline: 27 November 2026

Vacancies: 1 Vacancy

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Job Summary

Position Overview

FCDI is seeking a Senior Analytical Development Scientist to support the companys continued growth and several ongoing projects within the Analytical Development (AD) team located in Madison Wisconsin.

The AD team works cross-functionally to design develop optimize qualify and validate analytical methods used to characterize and release a diverse portfolio of induced pluripotent stem cell (iPSC)-derived cell therapy products for ocular oncological neurological and other diseases.

We are seeking an experienced self-motivated and detail-oriented scientist who can serve as a technical authority within the analytical development team for method transfer and development in preparation for qualification and this hands-on laboratory role you will collaborate closely with Analytical Development leadership method validation and senior technical staff to ensure that methods are adequately prepared for technology transfer into QC. This will be achieved by collaborating with the organizations subject matter experts on analytical methods and validation strategies that are scientifically sound phase-appropriate compliant with regulatory expectations and executed consistently.

The successful candidate will be motivated by the opportunity to plan execute and lead impactful work to help advance life-changing iPSC-derived therapies from development towards patient administration and enable FCDI to deliver these therapies efficiently safely and with the highest standards of quality. This is an onsite role located at our sites in the Madison WI area.

Company Overview

At FUJIFILM Cellular Dynamics were 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 were looking for bold innovators to join us.

At FUJIFILM Cellular Dynamics youll thrive in a collaborative and cutting-edge environment that encourages creativity and celebrates breakthroughs. If youre 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 70000 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: Description

Essential Job Functions

Independently conceive plan and lead analytical development activitiesfor multiple internal and external programs applying advanced scientific judgment to achieve project objectives and generate high-quality results.
Develop optimize and transfer analytical methodsacross internal teams and external clients. Lead comparability studies to support method process or product changes. Partner closely with R&D and technical teams to support the deployment of new technologies and innovative development approaches
Provide technical leadership and subject matter expertise for analytical method qualification and lifecycle strategies including protocol development establishment of acceptance criteria execution and definition of readiness criteria for qualification and formal method validation.
Apply expert knowledge of relevant method guidance such as but not limited to ICH USP ISO and FDA to ensure analytical methods are scientifically sound robust fit for purpose and compliant with regulatory expectations.
Lead analytical gap assessments and risk evaluationsto identify prioritize and proactively address technical and regulatory gaps in support of technology transfer IND submission project advancement and product development objectives. Serve as a subject matter expert during technology transfer and analytical development activities.
Analyze and interpret complex scientific data troubleshoot technical challenges and implement improvements to analytical methods equipment and work practices. Contribute scientific decision-making and enhance the teams technical capabilities.
Prepare and maintain accurate complete and compliant documentation including experimental records protocols technical reports SOPs method development and qualification documents presentations and other project-related records.
Communicate scientific findings and project statusto cross-functional teams clients and diverse internal or external audiences through technical presentations written reports and project summaries.
Collaborate effectively with cross-functional teamsto ensure analytical development activities meet project timelines quality standards and program requirements.
Drive the execution of strategic initiatives that support business objectives and organizational growth within the AD function.
Provide technical leadership training and mentorshipto junior and mid-level scientists promote consistency in experimental design data analysis and documentation and lead small- to mid-sized project teams as assigned.
Identify and develop innovative potentially patentable components methods systems or processesin support of the organizations research and development objectives.
Perform other related duties as assigned.

Qualifications

PhD in in a scientific or engineering discipline or other closely related field plus at least three (3) years of related experience; or a Masters degree in a comparable field plus at least seven (7) years of relevant experience; or a Bachelors degree in a comparable field plus at least ten (10) years of related experience.
Demonstrated experience leading method qualification and validation-readiness efforts including protocol authorship acceptance criteria definition and application of ICH Q2 and Q14 principles to build risk-based analytical strategies in a relevant industry setting (preferably in a CDMO setting)
Experience transitioning methods from development to QC protocol execution required.
Demonstrated proficiency and independence with multiple molecular and/or cell-based analytical methods including flow cytometry PCR and ELISA; stem cell culture experience or experience with our differentiated cell product line is highly valuable.
Demonstrated work ethic initiative the ability to multi-task and intellectual curiosity to gain new technical skills.
Proficiency in written and oral communication with demonstrated ability to communicate effectively with internal and external stakeholders at all levels.
Able to work well independently and in a team with demonstrated experience training guiding and mentoring junior and mid-level staff.
Strong problem-solving skills with demonstrated ability to manage multiple technical projects independently including flexibility to change project objectives quickly and willingly.
Some evening and/or weekend work is required.
Able to work at computer for extended periods of time.
Able to work in laboratory hood for extended periods of time.
Able to work with hazardous materials (i.e. chemicals electrical equipment and human tissue) without endangering oneself or others. Training will be required.
Able to wear standard laboratory PPE.

EEO Information

Fujifilm is committedto 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 ().

Required Experience:

Senior IC

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About Company

Fujifilm

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