# Staff Technical Operations Scientist

**Company**: Freenome
**Location**: Brisbane, California
**Work arrangement**: hybrid
**Experience**: staff
**Job type**: full-time
**Salary**: $157,675.00 - $221,550.00
**Category**: Operations
**Industry**: Healthcare

**Apply**: https://job-boards.greenhouse.io/freenome/jobs/8864622002?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_8865bfa7-597

## Description

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.

## Skills

### Required
- Next-Generation Sequencing (NGS) workflows
- CLIA laboratory setting
- GMP-regulated environment
- CAP/CLIA
- ISO13485 or IVD environment
- process validation principles
- test method validation
- manufacturing investigations
- CAPA
- change control
- quality systems
- automated Liquid handling
- statistical software

### Nice to have
- Lean
- Six Sigma
- continuous improvement methodologies
- Netsuite
- LIMS
- electronic batch records

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Source: [Apply at job-boards.greenhouse.io](https://job-boards.greenhouse.io/freenome/jobs/8864622002?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)