Senior Analytical Development Scientist

Fujifilm•Madison, WI

2d•Onsite

About The Position

FCDI is seeking a Senior Analytical Development Scientist to support the company’s 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 team for analytical method development, qualification, validation, comparability, and lifecycle management. In this hands-on laboratory role, you will collaborate closely with AD management and senior technical staff to ensure that methods are adequately prepared for qualification or validation and analytical methods and validation strategies 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.

Requirements

PhD in in a scientific or engineering discipline or other closely related field plus at least three (3) years of related experience; or a Master’s degree in a comparable field plus at least seven (7) years of relevant experience; or a Bachelor’s 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.
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.

Nice To Haves

stem cell culture experience or experience with our differentiated cell product line is highly valuable.

Responsibilities

Independently conceive, plan, and lead analytical development activities for multiple internal and external programs, applying advanced scientific judgment to achieve project objectives and generate high-quality results.
Develop, optimize, and transfer analytical methods across 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 ICH, USP, ISO, FDA, and other relevant requirements to ensure analytical methods are scientifically sound, robust, fit for purpose, and compliant with regulatory expectations.
Lead analytical gap assessments and risk evaluations to 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 team’s 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 status to cross-functional teams, clients, and diverse internal or external audiences through technical presentations, written reports, and project summaries.
Collaborate effectively with cross-functional teams to 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 mentorship to 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 processes in support of the organization’s research and development objectives.
Perform other related duties as assigned.