Staff Technical Operations Scientist

We are seeking a Staff Technical Operations Scientist to join the Freenome Manufacturing Science and Technology (MSAT) team. As a key member, you will be responsible for technology transfer and supporting root cause analysis of commercial issues. Your expertise in Next-Generation Sequencing (NGS) workflows and experience working within a CLIA laboratory setting will be essential in this role.

Responsibilities:

• Provide scientific and technical guidance for day-to-day Manufacturing/QC and Clinical Lab operations.
• Monitor process performance and analyze manufacturing/QC data to identify trends, variability, and opportunities for improvement.
• Lead investigations related to Manufacturing/QC nonconformances, out-of-specification (OOS) results, and process excursions using root cause analysis tools.
• Author Nonconformances reports, CAPAs, change controls, risk assessments, and technical documentation.
• Collaborate with cross-functional teams 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 activities for new products or process changes.
• Create validation documentation for Manufacturing/QC and ensure accuracy and compliance with GMP requirements.
• Create statistical analyses and preparation of 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.

Requirements:

• Bachelor's degree in Chemistry, Biology, Biochemistry, Biomedical Engineering, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline.
• 12 years of experience in pharmaceutical, biotechnology, medical device, or related regulated manufacturing environments.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to work effectively in a cross-functional, team-oriented environment.
• Proficiency with Microsoft Office applications, particularly Excel and PowerPoint.
• Experience with NGS workflows and chemistry.
• Experience working in a GMP-regulated environment, CAP/CLIA, ISO13485 or IVD environment.
• Knowledge of process validation principles and test method validation.
• Experience with manufacturing investigations, CAPA, change control, or quality systems.
• Experience with automated Liquid handling such as Hamilton/Tecan.
• Experience with statistical software such as JMP or Minitab/Python/R.

Nice to Have:

• Exposure to Lean, Six Sigma, or continuous improvement methodologies.
• Experience using systems such as Netsuite, LIMS, or electronic batch records.

Benefits:

• The US target range of our base salary rate for new hires is $157,675.00 - $221,550.00.
• You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered.