Job Title: Principal Scientist, Analytical Development

Location: Poway, CA

We are a recruitment agency working with a cutting-edge client in the regenerative medicine space, seeking a talented Principal Scientist to lead late-stage in-process and release analytical method development and validation. This is a fantastic opportunity to make an impact by driving key initiatives in analytical method lifecycle management, with a particular focus on cell-based potency assays.

As a scientific and strategic leader, you will collaborate with cross-functional teams, lead assay control strategies, and ensure the smooth transfer and validation of analytical methods at partner organizations. This role is perfect for someone with deep expertise in biotechnology, method validation, and commercial readiness in the field of regenerative therapy.

Key Responsibilities:

• Lead analytical method development, validation, and lifecycle management for late-stage and commercial programs.
• Oversee assay control strategies with a focus on cell-based potency methods.
• Collaborate with R&D and QC teams to improve test methods and troubleshoot issues.
• Author key technical documents such as SOPs, development reports, and risk assessments.
• Lead analytical method transfer and validation activities at partner organizations.
• Ensure regulatory compliance and prepare for health authority interactions.

Qualifications:

• Bachelor’s degree in Cell Biology, Analytical Chemistry, or a related field; advanced degree preferred.
• 8+ years of experience in developing analytical methods for biotechnology products, or 4+ years with a PhD.
• Expertise in cell biology, inflammation, and immunology, particularly in regenerative medicine.
• Proven success in managing late-stage to commercial analytical method validation and transfer.
• Strong communication skills and experience in cross-functional leadership.