Senior Analytical Development Scientist

About the role

The Senior Analytical Development Scientist position is available at FCDI, supporting the company’s growth and various projects within the Analytical Development team in Madison, Wisconsin. The team focuses on developing and validating analytical methods for iPSC-derived cell therapy products.

Responsibilities

• Independently conceive, plan, and lead analytical development activities for multiple internal and external programs.
• 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.
• 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, promoting consistency in experimental design, data analysis, and documentation.
• Identify and develop innovative, potentially patentable components, methods, systems, or processes in support of the organization’s research and development objectives.

Requirements

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

Qualifications

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