<p><strong>About this opportunity:</strong><strong><br></strong></p> <p><span style="font-weight: 300;">At Freenome, we are seeking a Staff Technical Operations Scientist to help grow the Freenome Manufacturing Science and Technology (MSAT) team. The ideal candidate is in Next-Generation Sequencing (NGS) workflows, detail-orientated, and familiar working within a CLIA laboratory setting. This person is responsible for all things related to Technology transfer and supporting root cause analysis of commercial issues. You are passionate about contributing to developing life-saving diagnostics through early cancer detection, and you will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer.</span></p> <p><span style="font-weight: 300;">The role reports to the Senior Manager of Technical Operations. This role will be a Hybrid role based in our Brisbane, California headquarters.</span></p> <p><strong>What you’ll do:</strong></p> <ul> <li style="font-weight: 300;"><span style="font-weight: 300;">Support day-to-day Manufacturing/QC and Clinical Lab operations by providing scientific and technical guidance.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Monitor process performance and analyze manufacturing/QC data to identify trends, variability, and opportunities for improvement.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Lead investigations related to Manufacturing/QC nonconformances, out-of-specification (OOS) results, and process excursions using root cause analysis tools.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Author Nonconformances reports, CAPAs, change controls, risk assessments, and technical documentation.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Collaborate with cross-functional teams to implement corrective and preventive actions that improve process reliability and product quality.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Lead process validation, equipment qualification, and technology transfer activities.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Participate in Manufacturing/QC readiness activities for new products or process changes.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Create validation documentation for Manufacturing/QC and ensure accuracy and compliance with GMP requirements.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Create statistical analyses and preparation of technical reports to support process monitoring and decision-making.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Lead continuous improvement initiatives focused on process chemistry efficiency.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Maintain knowledge of applicable regulatory requirements, GMP guidelines, and company procedures.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Present technical findings and project updates to internal stakeholders.<br></span></li> </ul> <p><strong>Must haves:</strong></p> <ul> <li style="font-weight: 300;"><span style="font-weight: 300;">Bachelor's degree in Chemistry, Biology, Biochemistry, Biomedical Engineering, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">12 years of experience in pharmaceutical, biotechnology, medical device, or related regulated manufacturing environments (internships and co-op experience may be considered).<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Strong analytical and problem-solving skills.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Excellent written and verbal communication skills.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Ability to work effectively in a cross-functional, team-oriented environment.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Proficiency with Microsoft Office applications, particularly Excel and PowerPoint.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Experience with NGS workflows and chemistry.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Experience working in a GMP-regulated environment, CAP/CLIA, ISO13485 or IVD environment.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Knowledge of process validation principles and test method validation.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Experience with manufacturing investigations, CAPA, change control, or quality systems.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Experience with automated Liquid handling such as Hamilton/Tecan. <br></span></li> <li style="font-weight: 300;"><spa