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Salary: USD 157,675 - 221,550 / annual
Freenome is seeking a Staff Technical Operations Scientist to join the Manufacturing Science and Technology (MSAT) team. This role is critical to supporting the company's mission of developing life-saving early cancer detection diagnostics through next-generation sequencing (NGS) workflows.
You will report to the Senior Manager of Technical Operations and serve as a technical expert supporting day-to-day manufacturing, quality control, and clinical laboratory operations. Your responsibilities include:
• Provide scientific and technical guidance to manufacturing and QC teams
• Monitor process performance and analyze manufacturing/QC data to identify trends, variability, and improvement opportunities
• Lead investigations into manufacturing/QC nonconformances, out-of-specification results, and process excursions using root cause analysis tools
• Author nonconformance reports, CAPAs (Corrective and Preventive Actions), change controls, risk assessments, and technical documentation
• Collaborate cross-functionally to implement corrective and preventive actions that improve process reliability and product quality
• Lead process validation, equipment qualification, and technology transfer activities
• Participate in manufacturing/QC readiness for new products or process changes
• Create validation documentation ensuring accuracy and GMP compliance
• Perform statistical analyses and prepare technical reports to support process monitoring and decision-making
• Lead continuous improvement initiatives focused on process chemistry efficiency
• Maintain knowledge of applicable regulatory requirements, GMP guidelines, and company procedures
• Present technical findings and project updates to internal stakeholders
This is a hybrid role based in Brisbane, California headquarters.
REQUIREMENTS:
Must-Have:
• Bachelor's degree in Chemistry, Biology, Biochemistry, Biomedical Engineering, Chemical Engineering, Pharmaceutical Sciences, or related scientific discipline
• 12 years of experience in pharmaceutical, biotechnology, medical device, or related regulated manufacturing environments (internships and co-op experience may be considered)
• Strong analytical and problem-solving skills
• Excellent written and verbal communication skills
• Ability to work effectively in cross-functional, team-oriented environments
• Proficiency with Microsoft Office applications, particularly Excel and PowerPoint
• Experience with NGS workflows and chemistry
• Experience working in GMP-regulated environments (CAP/CLIA, ISO13485, or IVD)
• Knowledge of process validation principles and test method validation
• Experience with manufacturing investigations, CAPA, change control, or quality systems
• Experience with automated liquid handling systems (Hamilton/Tecan)
• Experience with statistical software (JMP, Minitab, Python, or R)
Nice-to-Have:
• Exposure to Lean, Six Sigma, or continuous improvement methodologies
• Experience with systems such as Netsuite, LIMS, or electronic batch records
