Staff Technical Operations Scientist

Freenome; Brisbane (CA); Hybrid; USD 158,000 - 222,000; Full time

Job summary

Freenome seeks a Staff Technical Operations Scientist to advance the Manufacturing Science and Technology (MSAT) team in a hybrid Brisbane, CA setting. You will lead technology transfer, root cause analysis of commercial issues, and support Manufacturing/QC and clinical lab operations in an NGS-driven environment.

You will influence process validation, equipment qualification, CAPA, and change controls while working cross-functionally to improve product quality and regulatory compliance.

Qualifications

• Bachelor's degree in a related scientific discipline.
• 12 years of regulated manufacturing experience in pharma/biotech/medical devices.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Cross-functional collaboration in a team environment.
• Proficiency with Excel and PowerPoint.
• NGS workflows and chemistry experience.
• GMP/CAP/CLIA/ISO13485 or IVD environment experience.
• Process validation and test method validation knowledge.
• Experience with manufacturing investigations, CAPA, change control, or quality systems.
• Experience with automated liquid handling (Hamilton/Tecan).
• Experience with JMP or Minitab/Python/R.

Responsibilities

• Provide scientific and technical guidance to day-to-day Manufacturing/QC and Clinical Lab operations.
• Monitor process performance and data to identify trends and improvement opportunities.
• Lead investigations on nonconformances, OOS results, and process excursions via root cause analysis.
• Author nonconformance reports, CAPAs, change controls, risk assessments, and technical docs.
• Collaborate with cross-functional teams to implement corrective actions for reliability and quality.
• Lead process validation, equipment qualification, and technology transfer activities.
• Prepare validation documentation for Manufacturing/QC and regulatory compliance.
• Develop statistical analyses and technical reports to support decision-making.
• Drive continuous improvement in process chemistry efficiency.
• Maintain knowledge of regulatory GMP requirements and company procedures.
• Present findings and project updates to stakeholders.

Skills

Analytical thinking

Problem solving

Communication skills

Cross-functional collaboration

GMP/CLIA knowledge

Statistical software (JMP/Minitab/R)

Experience with NGS workflows

Process validation knowledge

CAPA/change control quality systems

Automated liquid handling (Hamilton/TE

Education

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

Tools

Hamilton/Tecan

Excel

PowerPoint

LIMS/NetSuite/ELBR

Job description

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 CCAA Notice at Collection here:

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Freenome’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.