Molecular Biology Scientist, Analytical Development Lead

Kenai Therapeutics

San Diego (CA)

On-site

USD 110,000 - 135,000

Full time

12 days ago

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Job summary

Kenai Therapeutics seeks a Scientist to join the Analytical Development team in San Diego, on-site, to develop, optimize and validate molecular analytical methods for our programs from early development through commercial launch.

You will design ddPCR/qPCR assays, manage lab operations, analyze data and generate reports while maintaining rigorous documentation and complying with regulatory expectations for cell therapy programs.

Qualifications

Ph.D. or M.S. with relevant industry analytical development experience.
Strong molecular biology assay development and data interpretation.
Experience with cell handling and GMP concepts.
Familiarity with regulatory guidelines and method lifecycle.
Excellent scientific writing and collaboration skills.

Responsibilities

Lead design, development and qualification/validation of molecular biology assays.
Plan and execute lab activities including instrument setup and data analysis.
Maintain cell lines and banks used in assay development.
Design standardized workflows and robust assay strategies.
Perform phase-appropriate robustness studies per regulatory guidelines.
Generate and present data in cross-functional meetings.
Prepare reports, SOPs and other documentation.
Support transfers and validation in GMP environments.
Ensure assays meet regulatory expectations for cell therapy.