Scientist, Analytical Development

Responsibilities

• Independently design, plan and conduct multicolor flow cytometry-based laboratory experiments.
• Execute all aspects of flow cytometry daily activities, including instrument setup, sample preparation, staining, acquisition, and data analysis using different instrument software and/or external industry standard software packages.
• Maintain and manage cell lines and banks for use in analytical assay development work.
• Implement scientifically sound gating strategies and establish standardized analysis templates.
• Design and perform assay robustness studies and troubleshoot signal artifacts, background populations, and spectral overlap issues.
• Generate, analyze, and present scientific data in cross-functional meetings.
• Prepare assay development/technical reports, protocols, standard operating procedures and other relevant documents following industry standard documentation practices.
• Conduct risk/gap assessments for method development and optimization at various phases of program lifecycle.
• Ensure assays are fit-for-purpose and aligned with phase-appropriate regulatory expectations by exhibiting a strong understanding of regulatory principles as applicable to analytical development and validation activities.
• Keep current on relevant scientific literature, new technologies/capabilities and support their implementation, as appropriate.
• Maintain detailed records of executed lab work and reported results and data interpretation using electronic lab notebooks.
• Partner with Process Development, Quality, Research teams and external CRO's and vendors to ensure analytical readiness for clinical milestones.
• Demonstrate Excellent written, verbal and interpersonal communication skills.

Requirements

• Ph.D. in Immunology, Cell Biology, Neuroscience or related field with 2-5 years or M.S. with 6+ years of analytical development relevant industry experience.
• Deep expertise in multiparameter flow cytometry assay development, analysis, compensation and gating strategies.
• Strong understanding of ICH guidelines for analytical method development and validation and phase appropriate method lifecycle management.
• Scientifically strong technical writing skills.
• Strong analytical skills and experience in operating and maintaining advanced flow cytometry instruments, eg., CytoFLEX, MacsQuant, Attune, and/ or equivalent platforms.
• Strong understanding of cell therapy product characterization (e.g., iPSC/ESC-derived).
• Proficiency with FlowJo, CytExpert, and/or equivalent data analysis platforms.
• Excellent organization skills and time management skills to work independently and balance multiple tasks and projects.
• Hands-on experience with cell handling of suspension/adherent cultures in BSC operations.
• Ability to clearly convey scientific findings and development rationale.
• Ability to work in a small, fast-paced cross collaborative environment with strong listening, communication and collaboration skills.