Job Description
Personalis, Inc. is a leader in advanced genomics for precision oncology. NeXT Personal is an ultra-sensitive, tumor-informed, WGS-based liquid biopsy assay designed to detect minimal residual disease (MRD) and cancer recurrence. It leverages whole-genome sequencing of a patient’s tumor and matched normal samples to create personalized panel of up to 1,800 somatic variants, enabling the detection of circulating tumor DNA (ctDNA) at very low levels (down to ~1-3 PPM) in blood samples. To enable cancer and population sequencing, Personalis’ Clinical Laboratory was built with a focus on clinical accuracy, quality, big data, scale, and efficiency. Personalis is based in Fremont, California.
Days onsite: Mon/Tues/Thurs (3 days/week)
Duration: 6 Months
Position Summary:
We are seeking a detail-oriented Technical Writer with experience in next-generation sequencing (NGS) workflows and laboratory operations to lead the revision and standardization of Standard Operating Procedures (SOPs). This role will focus on updating existing documentation to align with the implementation of the Labbit Laboratory Information Management System (LIMS), ensuring accuracy, compliance, and usability across lab teams.
Responsibilities:
- Review, update, and standardize existing NGS SOPs to reflect new workflows enabled by Labbit LIMS
- Collaborate with laboratory scientists, quality assurance, and informatics teams to capture accurate process changes
- Translate complex laboratory and technical processes into clear, concise, and user-friendly documentation
- Ensure SOPs comply with regulatory and quality standards (e.g., CLIA, CAP, GxP, as applicable)
- Develop new SOPs, work instructions, and supporting documentation as needed for LIMS-integrated workflows
- Maintain version control, document traceability, and change history in accordance with quality systems
- Support document review cycles, incorporating stakeholder feedback and approvals
- Assist with training materials and job aids related to updated workflows and Labbit LIMS usage
- Identify gaps or inconsistencies in current documentation and recommend improvements
Required Qualifications:
- Bachelor’s degree in Life Sciences, Technical Communication, or a related field
- 5+ years of technical writing experience in a laboratory or regulated environment
- Familiarity with next-generation sequencing (NGS) workflows (e.g., library prep, sequencing, data handling)
- Experience writing and maintaining SOPs in a quality-controlled environment
- Strong understanding of LIMS concepts; experience with Labbit or similar LIMS platforms preferred
- Excellent written and verbal communication skills
- Strong attention to detail and ability to manage multiple document revisions simultaneously
Preferred Qualifications:
- Experience supporting LIMS implementation or system migrations
- Knowledge of regulatory standards (CLIA, CAP, FDA, GxP)
- Experience working in genomics, molecular diagnostics, or biotech environments
- Familiarity with document management systems (e.g., ComplianceQuest, MasterControl, or similar)
Key Competencies:
- Ability to distill complex technical workflows into clear documentation
- Strong collaboration and stakeholder management skills
- Highly organized with excellent version control discipline
- Adaptability in a fast-changing, implementation-driven environment
The hiring range for this position is$60.00 to $75.00 per hour.
Personalis is an equal opportunity employer and is committed to the full inclusion of all individuals. As part of this commitment, Personalis will ensure that persons with disabilities are provided with reasonable accommodations. If you need an accommodation to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please let your recruiter know, if/when they contacts you.
Protecting Our Candidates: At Personalis, we value your security. Please note that all official correspondence from our team will come exclusively from @ personalis.com email addresses. We will never ask for personal financial information or conduct interviews over text or chat platforms. If you receive a suspicious request, it is likely a scam. We are committed to a safe recruitment experience and actively work with authorities to investigate and prosecute cyber crimes targeting our community.
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