Job Application for Staff Technical Operations Scientist at Freenome

New

About this opportunity:

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:

California Consumer Privacy Act (CCPA)

#LI-HYBRID

Create a Job Alert

Interested in building your career at Freenome? Get future opportunities sent straight to your email.

First Name

Last Name

Country

Phone

Location (City)

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Do you have experience running, developing, transferring, validating, or troubleshooting NGS assays on automated liquid handlers such as Hamilton, Tecan, Bravo, or comparable platforms?

Select...

Do you have hands-on experience with test method validation and/or process validation in a regulated life science, diagnostics, medical device, or clinical laboratory environment?

Select...

Have you worked in an ISO 13485, IVD, FDA 510(k), or comparable regulated diagnostics/medical device quality system environment?

Select...

Are you legally authorized to work in the United States?

Select...

Will you now or in the future require sponsorship for an employment visa status (e.g., H-1B, TN, O-1, etc.) to work for our company?

Select...

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 hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential 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.

Gender

Select...

Are you Hispanic/Latino?

Select...

Race & Ethnicity Definitions

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 measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is 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.

Veteran Status

Select...

Staff Technical Operations Scientist

Apply for this job

Voluntary Self-Identification