Director Flow Cytometry, Analytical Development

Descripción del trabajo

We are seeking a highly experienced Director of Analytical Operations to lead the Flow Assay Development Team within Analytical Operations. This role will be responsible for the development, optimization, validation, and life cycle management of flow cytometry-based analytical methods to support cell therapy products from early-phase development through commercial launch. The successful candidate will provide strategic leadership, technical expertise, team leadership and cross-functional collaboration to ensure the robustness, scalability, and regulatory compliance of flow-based assays.

Responsibilities

• Lead a high-performing technical team, fostering mentorship, scientific guidance, and career development.
• Drive the development, optimization, and validation of flow cytometry assays for cell therapy release.
• Ensure assay robustness and reproducibility for commercial manufacturing through experimental design and execution.
• Oversee technical documentation, regulatory submissions, and alignment with commercial product lifecycle.
• Stay at the forefront of advancements in flow cytometry technology, instrumentation, and analytical methodologies.
• Provide strategic direction in assay development, panel design, troubleshooting, and data interpretation.
• Lead high-impact projects that advance organizational objectives and product timelines.
• Represent Analytical Operations in internal and external collaborations, ensuring compliance with industry standards.
• Cultivate a culture of excellence, innovation, and cross-functional collaboration.

Basic Qualifications

• Ph.D. in Immunology, Cell Biology, Bioengineering, or related field with 8+ years of experience or
• Master's degree in in Immunology, Cell Biology, Bioengineering, or related field with10+ years of experience or
• Bachelor's degree in in Immunology, Cell Biology, Bioengineering, or related field with12+ years of experience

Preferred Qualifications:

• 8+ years of related industry experience
• Extensive expertise in flow cytometry-based assay development with strong understanding of cytometry platforms, instrumentation, and fluorophore-based detection.
• Experience in analytical method validation for regulatory submissions (IND, BLA).
• Solid grasp of cGMP and regulatory guidelines related to analytical methods for biologics/cell therapy.
• Commercial experience in assay development for late-stage clinical trials and commercial manufacturing.
• Strong background in multi-parameter flow cytometry, immunology, and/or translational sciences.
• Proficiency in flow cytometry analysis software such as FlowJo, FCS Express, and/or OMIQ.
• Ability to interact with stakeholders to understand program needs, assay specifics, timelines, and data delivery.
• Experience in working with vendor labs to transfer in-house assays and oversee external data quality.
• Strong communication and scientific writing skills.
• Ability to effectively lead, mentor and develop a scientific team
• Excellent cross-functional collaboration skills