Staff Technical Operations Scientist

Wwshemi; California; Hybrid; USD 158,000 - 222,000; Full time

Benefits offered by this job

Equity

Cash bonuses

Medical benefits

Job summary

Freenome Brisbane, California is seeking a Staff Technical Operations Scientist to grow the MSAT team in an NGS-focused CLIA environment. Hybrid role based in Brisbane, CA headquarters, reporting to the Senior Manager of Technical Operations.

You will lead technology transfer, investigations, CAPAs, validation, and cross-functional collaboration to ensure GMP-compliant manufacturing and QC performance, with a strong emphasis on data-driven process improvements and regulatory readiness.

Qualifications

• Bachelor's degree in a related scientific discipline and 12 years of industry experience in regulated environments.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication, and cross-functional collaboration.
• Experience in GMP, CAP/CLIA, ISO13485 or IVD environments.
• Experience with manufacturing investigations, CAPA, change control, and quality systems.

Responsibilities

• Support day-to-day Manufacturing/QC and Clinical Lab operations with scientific guidance.
• Monitor process performance and analyze data for trends and improvements.
• Lead investigations for nonconformances, OOS, and process excursions using root-cause tools.
• Author nonconformances, CAPAs, change controls, and risk assessments.
• Collaborate to implement corrective/preventive actions to improve reliability and quality.
• Lead process validation, equipment qualification, and technology transfer.
• Prepare validation documentation and regulatory-compliant records.
• Create statistical analyses and technical reports to support decisions.
• Lead continuous improvement initiatives in process chemistry.
• Maintain knowledge of GMP and company procedures.
• Present findings to internal stakeholders.

Skills

GMP experience

Root cause analysis

NGS workflows

CAPA

Process validation

Data analysis

Technical writing

Cross-functional teamwork

Education

Bachelor's degree in Chemistry, Biology, Biochemistry, Biomedical Engineering, Chemical Engineering, Pharmaceutical Sciences or related

Tools

Hamilton/Tecan

JMP

Minitab

Python

R

Netsuite

LIMS

Electronic batch records

Excel

PowerPoint

Job description

Freenome Brisbane, California Posted 2026-10-06

Location Brisbane, California

Lab Operations

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.

The role reports to the Senior Manager of Technical Operations. This role will be a Hybrid role based in our Brisbane, California headquarters.

What you’ll do:

• Support day-to-day Manufacturing/QC and Clinical Lab operations by providing scientific and technical guidance.
• 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.

Must haves:

• 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 (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 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 haves:

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

Benefits and additional information:

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. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.

Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.

California applicants please review the CCPA Notice at Collection here: